SlideShare a Scribd company logo
1 of 6
Download to read offline
BUSINESS BENEFITS FOR 2015:
• LISTEN to keynote addresses from the leaders in human
factors engineering with expert input on reaching
certain patient populations, considerations and
compliance in device design and how can we ensure
the drug product is administered safely and effectively
• LEARN about the critical issues surrounding safety
assessments of pre-filled syringes from extractables
and leachables to sterility and needle stick prevention
requirements – NEW FOR 2015
• ENHANCE your understanding of labelling and pricing
considerations with the competitive market for
biosimilars set to storm with patent expiries due
• ASSESS the future of pre-filled syringes with case study
led presentations addressing the challenges faced
with parenteral packaging innovations and reviewing
the strategies needed to overcome the hurdles with
importance insights into autoinjectors and pens
• ADDRESS the use of lyophilisation in pre-filled syringes,
is this the future vision?
SMi presents its 2nd annual conference and exhibition on...
PLUS TWO INTERACTIVE HALF-DAY POST-CONFERENCE WORKSHOPS
Wednesday 29th April 2015, Renaissance Woodbridge Hotel, Iselin, New Jersey, USA
27 - 28
APRIL
2015
Assessing the future of pre-filled syringes to improve innovation
and device development
Renaissance Woodbridge Hotel, Iselin, New Jersey, USA
Pre-Filled Syringes
America
www.pfsamericas.com
BOOK BY 27TH FEBRUARY AND SAVE $100
Register online or call +448709090711 to speak to an account executive
"Excellent, informative and good quality"
Delegate 2014
Advanced Delivery Systems to Enable
Personalised Medicines
Workshop Leaders: Ravi S. Harapanhalli, Vice President, ParExel and
Mr. Sall, Principal Consultant, ParExel
8.30am – 12.30pm
Will Drug Delivery in Coming Days be an Integral Part of DDM?
- Diagnose, Deliver and Monitor
Workshop Leaders: Chanderkanth Gautham, Domain Lead of Medical Device Team,
Beroe Inc. and Saikrishna Garrepalli, Procurement Management Representative,
Beroe Inc.
1.30pm – 5.30pm
CHAIRS FOR 2015:
Ravi Harapanhalli,
Vice President,
ParExel
William Beierschmitt,
Research Fellow, Drug Safety Research
and Development,
Pfizer Inc.
KEY SPEAKERS FOR 2015:
• Natalia Mazaeva, Usability Leader, Sanofi
• Stephen Barat, Executive Director, Forest Laboratories,
a subsidiary of Actavis
• Ed Israelski, Director of Human Factors, AbbVie
• Scott Brown, Device Development Lead, Merck
• Li-Chun Tsou, Global Device Technical Director,
AstraZeneca Pharmaceuticals
• Kiran Singh, Associate Director, Sandoz
• Michel Mikhail, Former Chief Regulatory Officer,
Executive Vice President, Global Regulatory -
Governmental Relations, Fresenius Kabi NV/SA
• Mark Tsai, Principal Engineer, Drug Delivery, Janssen
Pharmaceuticals
Plus many more...
BOOK BY
27TH FEBRUARY
AND SAVE $100
@SMIPHARM
#USAPFSSMI
Sponsored by
Pharmaceutical industry’s perspectives:
• Drug stability (minimize drug-syringe interactions by
mitigating leachables and extractables, flakes (lamellae)
or deposits, glass fragments, and lubricant particles)
• Syringe durability
• Cost
Manufacturer’s perspectives:
• Simplified manufacturing/assembly processes to mitigate
batch variances
• Consider stringent sterilization and packaging processes
• Compliance of the mandatory "safety" PFS
Healthcare industry’s perspectives:
• Avoid needlestick injuries
• User-friendly
• Eco-friendly (minimum residual of medicine,
recyclable device material)
Patient's perspectives:
• User-friendly (convenience and safety in preparation
and self-administration)
• Eco-friendly (minimum residual of medicine,
recyclable device material)
• Price-friendly
Pre-Filled Syringes America
Day One | Monday 27th April 2015
8.30 Registration & Coffee
9.00 Chair’s Opening Remarks
William Beierschmitt, Research Fellow, Drug Safety Research and
Development, Pfizer Inc.
HUMAN FACTOR STUDIES
OPENING ADDRESS
9.10 The importance of the patient and how each individual differs
• Reviewing the patient populations and the needs of certain
individuals in device design
• How can we enhance products to ensure they’re
specifically designed for the patient’s needs?
• Evaluating the best outcome for the patients, what
factors should be considered
Ed Israelski, Director of Human Factors, AbbVie
9.50 Success Criteria – How can the FDA’s requirements be met?
• Demonstrating safety and effectiveness in the hands of the user
• Reviewing the design requirements for validation purposes
• Are the customer requirements being met in design transfer?
• Post –market surveillance – What observations can
be made?
Natalia Mazaeva, Sr. Usability Leader, Global Usability
and Risk Management, Device Development, Sanofi
CASE STUDY
10.30 End user needs and perspectives for device assembly
End User Needs and Perspectives are critical for final device delivery.
This presentation will address the injectable device trends and flexibility
required for an assembly machine to adapt to new market challenges
while incorporating the ‘Human Factor’. This presentation will also focus
on recent Regulatory updates (11608) for Combination Products
The lecture will show:
• Injectable Device Trends
• Human Factor - Increased focus on safety, usability and handling studies
• Flexible standardized platforms to handle customized
assembly of pens and auto-injectors
• Gentle handling of the filled glass container during
assembly of the device using proven liquid fill finish
handling technology
Dena Flamm, Product Manager, Robert Bosch GmbH
11.10 Morning Coffee
KEYNOTE ADDRESS
11.40 Convenience and compliance: empower the user
through good design
• Reducing concerns by the end user is critical, what steps can be
taken to increase patient satisfaction?
• Precision and safety go hand in hand, let’s address considerations
to ensure the product designed is safe and effective
• How do we ensure the patient receives the exact
dose intended?
Ben Bartfeld, Human Factors and Industrial Design
Consultant, Otsuka Consultant Pharmaceutical Companies
12.20 What makes a pre-filled syringes ergonomic?
• Addressing the importance of human factor studies
in device development
• Assessing the possibilities to ensure the drug product
is administered safely and effectively
• Working with clients concentrating on the design
based strategies
Saikrishna Garrepalli, Procurement Management
Representative, Beroe Inc.
1.00 The New Frontier: Advancing the quality and functionality
of drug delivery
Paul Chao, Core Team Leader, R&D Staff Engineer and
Justin Wright, Senior Director, Strategic Innovation,
BD Medical - Pharmaceutical Systems
1.40 BREAKOUT SESSION & OPPORTUNTY TO NETWORK PRE-LUNCH
• Are we seeing a growing trend in drug delivery being administered
outside traditional medical settings?
• How can we ensure this is safe?
Host: William Beierschmitt, Research Fellow, Drug Safety
Research and Development, Pfizer Inc.
2.00 Networking Lunch
CRITICAL ISSUES: SAFETY ASSESSMENT
3.00 Safety Evaluation of Leachables for Pre-Filled Syringe Drug Products
• Background on leachables and pre-filled syringes
• Why safety assessment for leachables is necessary
• How to approach and conduct a leachable safety
evaluation
• Current best practice recommendations and
examples
Stephen Barat, Executive Director, Forest Laboratories,
a subsidiary of Actavis
3.40 The Risk Assessment of Extractables - A Toxicological Window of
Opportunity
• Ensuring compatibility of the profile of the pre-filled
syringe with the biologic
• Avoiding changes in product quality
• Material selection and final assessment of leachables
William Beierschmitt, Research Fellow, Drug Safety
Research and Development, Pfizer Inc.
4.20 Innovating for safety: Let's be sharp to protect end-users with safe
injectable devices
• Needle stick injuries concerns and regulations
• Syringes breakage concerns:
- plastic as a glass alternative?
- injection devices to reduce stress on glass prefilled syringes
• Examples from prefilled syringes safety devices,
implanters and auto-injectors
• Balance value propositions for the patients and the
pharmaceutical perspective
Isabelle Delcroix, Business Development Director, Nemera
5.00 Afternoon Tea
5.30 CASE STUDY
Identifying incompatibility causes and challenges
• Assessing drug delivery studies and reflecting on the
impact
of incompatibility
• Assessing the specific fit of LAV valves and specific
issues surrounding prefilled syringe design
Kiran Singh, Associate Director, Sandoz GmbH
6.10 Assessing the safety of needle devices
• Looking at the global demand of safety needle
devices
• What necessary steps should be taken to ensure
a successful safety pre-filled syringe
• Creative design of safety pre-filled syringes
Pei-Yang Phillip Hsu, Chief Executive Officer, SaferMed
Technologies Co. Ltd.
6.50 ROUND TABLE DISCUSSION AND NETWORKING OPPORTUNITY
• Discussing the safety challenges surrounding pre-filled
syringes
Host: Pei-Yang Phillip Hsu, Chief Executive Officer,
SaferMed Technologies Co. Ltd
7.20 Chair's Closing Remarks and Close of Day One
NEW FOR
2015!
NEW FOR
2015!
Register online at: www.pfsamericas.com • Alternatively fax yo
Pre-Filled Syringes America
Day Two | Tuesday 28th April 2015
8.30 Registration & Coffee
9.00 Chair’s Opening Remarks
Ravi S. Harapanhalli, Vice President, ParExel
ENHANCING DEVICE DEVELOPMENT
OPENING ADDRESS
9.10 Getting to market: Regulatory perspective
• Defining a pre-filled syringe as a product or device
and its impact on regulatory approval
• Insight into the FDA’s current thoughts
Ravi S. Harapanhalli, Vice President, ParExel,
former FDA Senior Executive
9.50 Biosimilars and Delivery Devices…here we go!
• Patent expiries for biologics are creating a new
competitive market for biosimilars in particular
Monoclonal antibodies
• How to differentiate from the innovator with a device
• Factors to Review: e.g. Interchangeability studies
Michel Mikhail, Former Chief Regulatory Officer,
Executive Vice President, Global Regulatory
- Governmental Relations, Fresenius Kabi NV/SA
10.30 Room Temperature Sterilization of Pre-Filled Syringes
• The need for sterilization of prefilled syringes to be administered in
the sterile field
• Sterilization using Nitrogen Dioxide for temperature
sensitive products
• Regulatory pathways for nitrogen dioxide sterilization
Evan Goulet, Director, Sterilization Operations, Noxilizer, Inc.
11.00 Morning Coffee
CASE STUDY
11.30 The partnership reviewed between a pharmaceutical company and
the manufacturer/supplier
• Overview of the relationship and how it was managed
•An explanation on why the products have been developed
Shun Ogawa, Research Manager, Mitsubishi Gas
Chemical Company, Inc.
12.10 Combination Product Considerations- Starting with the End in Mind
• Evolving trends for the pre-filled syringe and self-injection markets
• Industry/Supplier partnership is key to successful development
outcomes
• Patient considerations and building strong product brands through
innovation
Royce Brockett, Senior Product Manager, West Pharmaceutical
Services, Inc.
ROUND TABLE DISCUSSION
12.50 The partnership reviewed between a pharmaceutical
company and the manufacturer/supplier
• Choosing a partner: What are the decision criteria?
• Who owns what: Equipment, IP, regulatory
requirements?
• Managing the partnership
Scott Brown, Executive Director/ Device Development
Lead, Merck Research Laboratories
1.20 Networking Lunch
KEYNOTE ADDRESS
2.20 Parenteral Device Strategy for Patient-Centric
Therapeutics
• Advantages and Constraints of Pre-filled Syringes
in Designing Cutting Edge Devices
• Global Design Control Process in Meeting Country
Specific Regulatory Expectations
• Concurrent Engineering Commercialization Model
in Achieving Successful New Product Launch
Li-Chun Tsou, Global Device Technical Director,
AstraZeneca Pharmaceuticals
3.00 Product Line Management, sustaining activities
• Engineering change plan
• Product enhancement, material change, CAPA
• Post market risk management
• Design control, sustaining activities
Mark Tsai, Principal Engineer, Cell Therapy, Janssen R&D
3.40 BREAKOUT SESSION & OPPORTUNTY TO NETWORK
• Glass v Plastic
• The advantages and disadvantages
• Is once still more favourable, if so why? Discuss
Host: Ravi Harapanhalli, Vice President, ParExel
4.20 Afternoon Tea
CASE STUDY
4.50 Process Development studies to optimize process
parameters and finalize presentation format
Case studies included:
• Development study to evaluate hold times on the
filing line
• Stopper movement studies to evaluate effect of
headspace
Aarti Gidh, Senior Scientific Investigator,
GlaxoSmithKline
5.30 Electronics and Mobile Apps role in drug delivery
and dosage adherence
• How electronics and mobile apps in device development are
going to affect dosage areas in the medical device space
• Some of major development in patch front which has circuitry
embedment and other innovative add on
• Increasing penetration of electronics in drug delivery
• Vision of leading device manufacturers and their take on
electronics future
• Role of mobile apps in complimenting the growth of
electronics in device arena
Chanderkanth Gautam, Domain Lead and Medical
Device Community Leader, Beroe Inc.
6.10 Chairman’s Closing Remarks and Close of Day Two
Official Platinum
Media Partner
NEW FOR
2015!
NEW FOR
2015!
NEW FOR
2015!
Supported by
ur registration to +44 (0)870 9090 712 or call +44 (0)870 9090 711
PHARMA
• What worked
(Existing Actions)
Pharma companies
sometimes use mono-layer
plastic containers to prevent
the below problems, but all
of them don’t have enough
oxygen barrier.
• What could’ve been
improved?
(Existing Problems for Glass
Container
- Breakage
- Heavy Weight
- Difficulty of disposal
- Protein Adsorption
- Inorganic Extractable, etc.
• Moving forward, what would
you have done differently?
(Future actions)
Some antioxidizing agent
might be used for injectable
drugs.
SUPPLIER
• What worked
(Existing solutions by suppliers)
Some supplies provide mono-
layer plastic containers
instead of glass, but all of
them don’t have enough
oxygen barrier.
• What could’ve been
improved?
- Oxygen Barrier
• Moving forward, what would
you have done differently?
(Our solutions)
- We developed an oxygen
absorbing polymer.
- We also developed 3 layers-
containers
- The oxygen absorbing
polymer is used for
the middle layer
- COP which is well-
known as a high
moisture
HALF-DAY POST CONFERENCE WORKSHOP AM
Wednesday 29th April 2015 | 8.30am – 12.30pm | Renaissance Woodbridge Hotel, Iselin, New Jersey, USA
Advanced Delivery Systems to Enable Personalised Medicines
Workshop Leaders: Ravi S. Harapanhalli, Vice President, ParExel and
Mr. Sall, Principal Consultant, ParExel
Workshop overview:
Run by one of the US’s leading figures in regulatory approval processes
and drug delivery systems, Dr. Ravi Harapanhalli. This industry leading
workshop will help you plan for smooth regulatory approvals and help with
avoiding pitfalls that can cause expensive delays in taking your product to
market.
Who should attend this workshop:
R&D Scientists, Regulatory Affairs, Device specialists, Formulators,
Business Development Staff
HALF-DAY POST CONFERENCE WORKSHOP PM
Wednesday 29th April 2015 | 1.30pm – 5.30pm | Renaissance Woodbridge Hotel, Iselin, New Jersey, USA
Will Drug Delivery in Coming Days be an Integral Part of DDM?
- Diagnose, Deliver and Monitor
Workshop Leaders: Chanderkanth Gautham, Domain Lead of Medical Device Team, Beroe Inc. and
Saikrishna Garrepalli, Procurement Management Representative, Beroe Inc.
Overview of workshop:
Drug delivery device market would no longer exist as standalone entity. As
healthcare longs to address all the solution through single gateway,
technologies such electronic bandage, artificial pancreas pave their way
into the market. They provide a holistic solution by diagnostic, delivering and
monitoring. This is likely to be future of healthcare.
Why you should attend this workshop:
• To understand the platform that will be face of healthcare in coming days.
• To understand how fast are new technologies are advancing in the space of
Medtech,andhowconsiderablethesedeviceswereinaddressingthegapthe
currently prevails will be the focus of the workshop.
About the workshop hosts:
Chanderkanth Gautham A Medical Device Procurement
Management Representative (Sr. Research Analyst) with
experiences in R&D, Human Factors, Contract Research Services
facilitating Medical Devices, Pharmaceutical, Cosmetics and
Herbal Companies with Product development, Regulatory and
Post Marketing (Medical Affairs) and Business Development
support activities across global regions.
Saikrishna Garrepalli Procurement Management Representative
(Sr. Research Analyst) of leading medical device companies, Sai
has experience in R&D, Human Factors, Contract Research
Services and regulatory pathways. Currently he is analyst at
Medical device team at Beroe handles various client initiatives
such as supplier relationship, negotiations and others.
About Beroe Inc.
Beroe is procurement pioneer which addresses USD 15 Billion+ spend of its
clients globally. It carefully monitors the market for any sort of trend at
supplier or buyers end. And is very instrumental in benchmarking markets
and supplier capabilities across various facets of value chain ranging from
design to manufacturing. beroeinc.com
Programme
8.30 Registration & Coffee
9.00 Introductions and Opening Remarks
9.45 Session 1: Quality-by-Design in the development
of drug delivery systems
10.30 Session 2: Regulatory pitfalls to avoid
11.00 Coffee break
11.30 Session 3: New combination product regulations
and how to comply with them
12.00 Session 4: How to accelerate approval through FDA
12.30 End of Workshop
Why you should attend this workshop:
• Accelerate the time it takes to
take your drug delivery system to
market
• Find out how to navigate new
combination product guidelines
• Assess the right time to start thinking
about your drug delivery
mechanism
• Develop a strategy for product life
cycle management by switching
over to PFS
• Understand how to apply the FDA
Quality SystemRegulation to
delivery device development
• Know how to apply FDA Design
Controls to delivery device
development
• Get to appreciate how to selection
of a delivery device development
partner
• Perform risk analysis and Human
Factors assessment
About the workshop host:
Dr. Ravi Harapanhalli advises bio/pharmaceutical companies on
CMC regulatory strategies and Quality-by-Design approaches to
medicinal product development and flexible regulatory
approaches.
About the workshop co-leader:
Mr. Sall is a Principal Consultant with PAREXEL Consulting in
Waltham, MA. PAREXEL provides clinical trial, clinical data
management, medical and regulatory services to the
pharmaceutical and medical device industries.
About ParExel:
Over the past 30 years, ParExel has developed significant expertise to
assist clients in the worldwide pharmaceutical, biotechnology and
medical device industries with the development and launch of their
products in order to bring safe and effective treatments to the global
marketplace for the patients who need them. Headquartered near
Boston, Massachusetts, ParExel operates over 77 locations throughout
more than 51 countries around the world, and has over 14,400
employees. www.parexel.com
Programme
1.30 Registration and Coffee
2.00 Will drug delivery in coming days be integral part of DDM
<diagnose, deliver and monitor>
Areas Covered
• Introduction on these developments
• Some case studies indicating the inception of the trend
• Will developments in non-invasive sensor based
technologies and automatic modes of delivery increase
inclination of patients and physicians to home care
technologies.
• Do acquisition of monitoring device companies by
Medtech giants’ indicate bigger role of DDM platforms
in future?
3.30 Coffee Break
4.00 Will artificial pancreas penetration in market pave way for
non-conventional diabetic therapy?
Areas to be covered
• Will the aforementioned platform challenge the
conventional, glucose measurement and injection
therapy to a significant amount?
• Does this mean that conventional modes insulin delivery
via auto injectors, pen injectors now needs a massive
scale up technology wise?
• Who are those technology pioneers that need special
mention on their recent developments in same space?
5.30 End of Workshop
SPONSORED BY:
SPONSORSHIP AND EXHIBITION OPPORTUNITIES
SMi offer sponsorship, exhibition, advertising and branding packages, uniquely
tailored to complement your company’s marketing strategy. Prime networking
opportunities exist to entertain, enhance and expand your client base within the
context of an independent discussion specific to your industry.
Should you wish to join the increasing number of companies benefiting from
sponsoring our conferences please call: Alia Malick on +44 (0) 20 7827 6168 or
email: amalick@smi-online.co.uk
Pre-Filled Syringes Americas
BD Medical – Pharmaceutical Systems provides high-quality, customized, clinically-proven drug delivery systems
to help pharmaceutical and biotechnology customers’ injectable drugs reach their full potential. BD offers a
range of products, including glass and plastic prefillable syringes and a variety of systems for the self-
administration of injectables. With a broad range of innovative systems and services, BD provides
pharmaceutical companies with support and resources to help them achieve their goals. www.bd.com
Bosch Packaging Technology is the world leader in the design and manufacture of pharmaceutical processing
and packaging systems. Bosch offers a range of syringe filling systems in both nested and bulk styles of systems.
Bosch also now offers syringe pen assembly systems and single use dosing systems with scalable solutions. With
Bosch one supplier solutions are a real possibility. www.boschpackaging.com
Ginolis provides automation solutions for manufacturing, laboratories and end-user instruments for medtech,
pharmaceutical and diagnostic companies. Ginolis also develops customer-specific disposable platform
solutions for high-volume applications. The company is privately owned and headquartered in Oulu, Finland,
with a subsidiary in Uppsala, Sweden and a sales and service site in San Diego, California.
http://ginolis.com/company-introduction
Mitsubishi Gas Chemical (MGC) is well-known as an expert in unique polymers and oxygen absorbers. Based on
our experience and expertise, MGC has successfully developed multilayer plastic vial and syringe with oxygen
absorbing function. MGC believes they will be an only solution to replace glass with plastic. www.mgc.co.jp/eng
Nemera is one of the world leaders in the design, development and manufacturing of drug delivery solutions. Its
expertise covers all five modes of delivery: parenteral (injectors, pens, safety devices) and also ophthalmic
(preservative free droppers), nasal, buccal, auricular (sprays pumps, etc.), pulmonary (inhalers), dermal and
transdermal (dispensers). Nemera provides solutions for the pharmaceutical industry, including standard
innovative products such as passive safety device for prefilled syringes Safe’n’Sound®, development of custom
devices and contract manufacturing. www.nemera.net
Noxilizer, Inc. provides a proprietary room temperature nitrogen dioxide sterilization technology that offers many
benefits over traditional methods. NO2 sterilization has shorter cycles (approximately 2 hours including aeration),
operates with/without vacuum and is easily installed—an ideal solution for prefilled syringes and drug-device
combination products. Noxilizer provides contract sterilization services and sells sterilization equipment. Noxilizer
Inc. was founded in 2004 and has offices in the US, United Kingdom, and Japan. www.noxilizer.com
West works side by side with its healthcare partners from concept to the patient, designing and manufacturing
packaging, diagnostic and delivery systems that promote the efficiency, reliability and safety of their products.
Every day, West is leading the way with cutting-edge technologies and quality systems, a thorough
understanding of global regulatory compliance, and an unmatched and growing knowledge base of relevant
pharmaceutical product testing, development and packaging. Based in Exton, Pa., West supports its customers
from sales, manufacturing, customer support and research and development locations in North and South
America, Europe, Asia and Australia. www.westpharma.com
Want to know how you can
get involved?
Interested in promoting your
services to this market?
Contact Julia Rotar, SMi Marketing
on +44 (0) 207 827 6088, or email:
jrotar@smi-online.co.uk
WHO SHOULD ATTEND:
Those involved in the following:
• Pharma Development
• Engineering
• Manufacturing
Technology
• Biopharma Operations
• Regulatory Affairs
• Parenterals
• Packaging
• Formulation Aseptic
• Device Development
• Device Design
• Labelling
• Manufacturing
• Drug Delivery
• Formulation & Aseptic
Filling Technologies
• Chemistry Manufacture
Controls (CMC)
• Quality Assurance
• Safe Medication
Practice
11
2BREAKOUT SESSIONS
4CASE STUDIES
LEADING PHARMA
COMPANIES SPEAKING
2KEYNOTE ADDRESSES
100+ATTENDEES
2 ROUND TABLE
DISCUSSIONS
Attendee by Location
USA 71%
Europe 17%
India 5%
Canada 7%
KEY HIGHLIGHTS:
FAX your booking form to +44 (0) 870 9090 712
PHONE on +44 (0) 870 9090 711
POST your booking form to: Events Team, SMi Group Ltd, 2nd Floor
South, Harling House, 47-51 Great Suffolk Street, London, SE1 0BS, UK
PRE-FILLED SYRINGES AMERICA
Conference: Monday 27th & Tuesday 28th April 2015, Renaissance Woodbridge Hotel, Iselin, New Jersey, USA Workshops: Wednesday 29th April 2015, USA
4 WAYS TO REGISTER
www.pfsamericas.com
If you have any further queries please call the Events Team on tel +44 (0) 870 9090 711 or you can email events@smi-online.co.uk
Payment: If payment is not made at the time of booking, then an invoice will be issued and must be
paid immediately and prior to the start of the event. If payment has not been received then credit
card details will be requested and payment taken before entry to the event. Bookings within 7 days
ofeventrequirepaymentonbooking.AccesstotheDocumentPortalwillnotbegivenuntilpayment
has been received.
Substitutions/Name Changes: If you are unable to attend you may nominate, in writing, another
delegate to take your place at any time prior to the start of the event. Two or more delegates may
not ‘share’ a place at an event. Please make separate bookings for each delegate.
Cancellation: If you wish to cancel your attendance at an event and you are unable to send a
substitute, then we will refund/credit 50% of the due fee less a £50 administration charge, providing
that cancellation is made in writing and received at least 28 days prior to the start of the event.
Regretfully cancellation after this time cannot be accepted. We will however provide the
conferences documentation via the Document Portal to any delegate who has paid but is unable
to attend for any reason. Due to the interactive nature of the Briefings we are not normally able to
provide documentation in these circumstances. We cannot accept cancellations of orders placed
for Documentation or the Document Portal as these are reproduced specifically to order. If we have
to cancel the event for any reason, then we will make a full refund immediately, but disclaim any
further liability.
Alterations: It may become necessary for us to make alterations to the content, speakers, timing,
venue or date of the event compared to the advertised programme.
Data Protection: The SMi Group gathers personal data in accordance with the UK Data Protection
Act 1998 and we may use this to contact you by telephone, fax, post or email to tell you about other
products and services. Unless you tick here □we may also share your data with third parties offering
complementary products or services. If you have any queries or want to update any of the data that
we hold then please contact our Database Manager databasemanager@smi-online.co.uk or visit
our website www.smi-online.co.uk/updates quoting the URN as detailed above your address on the
attached letter.
Unique Reference Number
Our Reference LVP-141
Terms and Conditions of Booking
DELEGATE DETAILS
Please complete fully and clearly in capital letters. Please photocopy for additional delegates.
Title: Forename:
Surname:
Job Title:
Department/Division:
Company/Organisation:
Email:
Company VAT Number:
Address:
Town/City:
Post/Zip Code: Country:
Direct Tel: Direct Fax:
Mobile:
Switchboard:
Signature: Date:
I agree to be bound by SMi's Terms and Conditions of Booking.
ACCOUNTS DEPT
Title: Forename:
Surname:
Email:
Address (if different from above):
Town/City:
Post/Zip Code: Country:
Direct Tel: Direct Fax:
VENUE Renaissance Woodbridge Hotel, Iselin, New Jersey, USA
□ Please contact me to book my hotel
Alternatively call us on +44 (0) 870 9090 711,
email: hotels@smi-online.co.uk or fax +44 (0) 870 9090 712
EARLY BIRD
DISCOUNT
Payment must be made to SMi Group Ltd, and received before the event, by one of
the following methods quoting reference P-141 and the delegate’s name. Bookings
made within 7 days of the event require payment on booking, methods of payment
are below. Please indicate method of payment:
A/C Name SMI GROUP LTD Sort Code 300009,
Account Number 11775391 CCY USD
□ Wire Transfer Lloyds TSB Bank plc, 39 Threadneedle Street, London, EC2R 8AU
IBAN GB75LOYD30000911775391
BIC LOYDGB21013
□ Cheque We can only accept cheques in US Dollars.
□ Credit Card □ Visa □ MasterCard □ American Express
All credit card payments will be subject to standard credit card charges.
Card No: □□□□ □□□□ □□□□ □□□□
Valid From □□/□□ Expiry Date □□/□□
CVV Number □□□□ 3 digit security on reverse of card, 4 digits for AMEX card
Cardholder’s Name:
Signature: Date:
I agree to be bound by SMi's Terms and Conditions of Booking.
Card Billing Address (If different from above):
DOCUMENTATION
I cannot attend but would like to purchase access to the following Document
Portal/paper copy documentation Price Total
□ Access to the conference documentation
on the Document Portal £499.00 + VAT £598.80
□ The Conference Presentations – paper copy £499.00 - £499.00
(or only £300 if ordered with the Document Portal)
PAYMENT
VAT
VAT at 20% is charged on Document Portal and literature distribution for all UK customers and
for those EU Customers not supplying a registration number for their own country here.
______________________________________________________________________________________________
CONFERENCE PRICES
I would like to attend: (Please tick as appropriate) Fee
□ Conference & 2 Workshops $2997.00
□ Conference & 1 Workshop AM □ PM □ $2398.00
□ Conference only $1799.00
□ 2 Workshops only $1198.00
□ 1 Workshop only AM □ PM □ $599.00
PROMOTIONAL LITERATURE DISTRIBUTION
□ Distribution of your company’s promotional
literature to all conference attendees £999.00 + VAT £1198.80
The conference fee includes refreshments, lunch, conference papers, and access to the
Document Portal. Presentations that are available for download will be subject to
distribution rights by speakers. Please note that some presentations may not be available
for download. Access information for the document portal will be sent to the e-mail
address provided during registration. Details are sent within 24 hours post conference.
□ Book by 27th February 2015 to receive $100 off the conference price

More Related Content

What's hot

Design is to do good not just be and look good: Bad Design is Smoke, Good Des...
Design is to do good not just be and look good: Bad Design is Smoke, Good Des...Design is to do good not just be and look good: Bad Design is Smoke, Good Des...
Design is to do good not just be and look good: Bad Design is Smoke, Good Des...Ajaz Hussain
 
Totality of Evidence & Theraputic Equivalence 15 October 2016
Totality of Evidence & Theraputic Equivalence 15 October 2016Totality of Evidence & Theraputic Equivalence 15 October 2016
Totality of Evidence & Theraputic Equivalence 15 October 2016Ajaz Hussain
 
QbR to QbD to CPV 16 February 2015
QbR to QbD to CPV 16 February 2015QbR to QbD to CPV 16 February 2015
QbR to QbD to CPV 16 February 2015Ajaz Hussain
 
Dr Venkateswarlu Memorial Lecture 2015
Dr Venkateswarlu Memorial Lecture 2015Dr Venkateswarlu Memorial Lecture 2015
Dr Venkateswarlu Memorial Lecture 2015Ajaz Hussain
 
IGPA Building a Culture of Quality Ajaz Hussain_5 Sept 2015_Rferences min
IGPA Building a Culture of Quality Ajaz Hussain_5 Sept 2015_Rferences minIGPA Building a Culture of Quality Ajaz Hussain_5 Sept 2015_Rferences min
IGPA Building a Culture of Quality Ajaz Hussain_5 Sept 2015_Rferences minAjaz Hussain
 
Product Quality & Patient Safety USP Workshop Mumbai 12 June 2015
Product Quality & Patient Safety USP Workshop Mumbai 12 June 2015Product Quality & Patient Safety USP Workshop Mumbai 12 June 2015
Product Quality & Patient Safety USP Workshop Mumbai 12 June 2015Ajaz Hussain
 
From Roadblocks to Roadmap 2017, with a 2020 Vision
From Roadblocks to Roadmap 2017, with a 2020 VisionFrom Roadblocks to Roadmap 2017, with a 2020 Vision
From Roadblocks to Roadmap 2017, with a 2020 VisionAjaz Hussain
 
Pharmaceutical Quality Assurance in the 21st Century, Sharper Focus Needed on...
Pharmaceutical Quality Assurance in the 21st Century, Sharper Focus Needed on...Pharmaceutical Quality Assurance in the 21st Century, Sharper Focus Needed on...
Pharmaceutical Quality Assurance in the 21st Century, Sharper Focus Needed on...Ajaz Hussain
 
FDA Trend: New Validation Strategies
FDA Trend: New Validation StrategiesFDA Trend: New Validation Strategies
FDA Trend: New Validation StrategiesAjaz Hussain
 
QbD and CoQ IDMA Mumbai 24 March 2015 slideshare
QbD and CoQ IDMA Mumbai 24 March 2015 slideshareQbD and CoQ IDMA Mumbai 24 March 2015 slideshare
QbD and CoQ IDMA Mumbai 24 March 2015 slideshareAjaz Hussain
 
Equivalence Assessment and Maturity of Quality Management Systems
Equivalence Assessment and Maturity of Quality Management SystemsEquivalence Assessment and Maturity of Quality Management Systems
Equivalence Assessment and Maturity of Quality Management SystemsAjaz Hussain
 
Continuous Manufacturing Regulatory Update
Continuous Manufacturing Regulatory Update Continuous Manufacturing Regulatory Update
Continuous Manufacturing Regulatory Update Ajaz Hussain
 
Chemometrics, Pharmacometrics and Econometrics Dimensions_of_Quality
Chemometrics, Pharmacometrics and Econometrics Dimensions_of_QualityChemometrics, Pharmacometrics and Econometrics Dimensions_of_Quality
Chemometrics, Pharmacometrics and Econometrics Dimensions_of_QualityAjaz Hussain
 
On FDA’s Guidance on Pharmaceutical Process Validation (2011)l
On FDA’s Guidance on Pharmaceutical Process Validation (2011)lOn FDA’s Guidance on Pharmaceutical Process Validation (2011)l
On FDA’s Guidance on Pharmaceutical Process Validation (2011)lAjaz Hussain
 
Critical Path Initiative Challenges: FDA ACPS Meeting 19 October 2004
Critical Path Initiative Challenges: FDA ACPS Meeting 19 October 2004Critical Path Initiative Challenges: FDA ACPS Meeting 19 October 2004
Critical Path Initiative Challenges: FDA ACPS Meeting 19 October 2004Ajaz Hussain
 
Sharpen your Unique Sensing Proclivity: Dissolution is a process in mind and ...
Sharpen your Unique Sensing Proclivity: Dissolution is a process in mind and ...Sharpen your Unique Sensing Proclivity: Dissolution is a process in mind and ...
Sharpen your Unique Sensing Proclivity: Dissolution is a process in mind and ...Ajaz Hussain
 
Defining a Commercially Viable Product | Manas Kanungo | Lunch & Learn
Defining a Commercially Viable Product | Manas Kanungo | Lunch & Learn Defining a Commercially Viable Product | Manas Kanungo | Lunch & Learn
Defining a Commercially Viable Product | Manas Kanungo | Lunch & Learn UCICove
 
CHIR Best Brains Exchange 22 January 2016
CHIR Best Brains Exchange 22 January 2016CHIR Best Brains Exchange 22 January 2016
CHIR Best Brains Exchange 22 January 2016Ajaz Hussain
 
SMi Group's Injectable Drug Delivery 2018 conference
SMi Group's Injectable Drug Delivery 2018 conferenceSMi Group's Injectable Drug Delivery 2018 conference
SMi Group's Injectable Drug Delivery 2018 conferenceDale Butler
 
SMi Group's 3rd annual Prefilled Syringes East Coast 2016
SMi Group's 3rd annual Prefilled Syringes East Coast 2016SMi Group's 3rd annual Prefilled Syringes East Coast 2016
SMi Group's 3rd annual Prefilled Syringes East Coast 2016Dale Butler
 

What's hot (20)

Design is to do good not just be and look good: Bad Design is Smoke, Good Des...
Design is to do good not just be and look good: Bad Design is Smoke, Good Des...Design is to do good not just be and look good: Bad Design is Smoke, Good Des...
Design is to do good not just be and look good: Bad Design is Smoke, Good Des...
 
Totality of Evidence & Theraputic Equivalence 15 October 2016
Totality of Evidence & Theraputic Equivalence 15 October 2016Totality of Evidence & Theraputic Equivalence 15 October 2016
Totality of Evidence & Theraputic Equivalence 15 October 2016
 
QbR to QbD to CPV 16 February 2015
QbR to QbD to CPV 16 February 2015QbR to QbD to CPV 16 February 2015
QbR to QbD to CPV 16 February 2015
 
Dr Venkateswarlu Memorial Lecture 2015
Dr Venkateswarlu Memorial Lecture 2015Dr Venkateswarlu Memorial Lecture 2015
Dr Venkateswarlu Memorial Lecture 2015
 
IGPA Building a Culture of Quality Ajaz Hussain_5 Sept 2015_Rferences min
IGPA Building a Culture of Quality Ajaz Hussain_5 Sept 2015_Rferences minIGPA Building a Culture of Quality Ajaz Hussain_5 Sept 2015_Rferences min
IGPA Building a Culture of Quality Ajaz Hussain_5 Sept 2015_Rferences min
 
Product Quality & Patient Safety USP Workshop Mumbai 12 June 2015
Product Quality & Patient Safety USP Workshop Mumbai 12 June 2015Product Quality & Patient Safety USP Workshop Mumbai 12 June 2015
Product Quality & Patient Safety USP Workshop Mumbai 12 June 2015
 
From Roadblocks to Roadmap 2017, with a 2020 Vision
From Roadblocks to Roadmap 2017, with a 2020 VisionFrom Roadblocks to Roadmap 2017, with a 2020 Vision
From Roadblocks to Roadmap 2017, with a 2020 Vision
 
Pharmaceutical Quality Assurance in the 21st Century, Sharper Focus Needed on...
Pharmaceutical Quality Assurance in the 21st Century, Sharper Focus Needed on...Pharmaceutical Quality Assurance in the 21st Century, Sharper Focus Needed on...
Pharmaceutical Quality Assurance in the 21st Century, Sharper Focus Needed on...
 
FDA Trend: New Validation Strategies
FDA Trend: New Validation StrategiesFDA Trend: New Validation Strategies
FDA Trend: New Validation Strategies
 
QbD and CoQ IDMA Mumbai 24 March 2015 slideshare
QbD and CoQ IDMA Mumbai 24 March 2015 slideshareQbD and CoQ IDMA Mumbai 24 March 2015 slideshare
QbD and CoQ IDMA Mumbai 24 March 2015 slideshare
 
Equivalence Assessment and Maturity of Quality Management Systems
Equivalence Assessment and Maturity of Quality Management SystemsEquivalence Assessment and Maturity of Quality Management Systems
Equivalence Assessment and Maturity of Quality Management Systems
 
Continuous Manufacturing Regulatory Update
Continuous Manufacturing Regulatory Update Continuous Manufacturing Regulatory Update
Continuous Manufacturing Regulatory Update
 
Chemometrics, Pharmacometrics and Econometrics Dimensions_of_Quality
Chemometrics, Pharmacometrics and Econometrics Dimensions_of_QualityChemometrics, Pharmacometrics and Econometrics Dimensions_of_Quality
Chemometrics, Pharmacometrics and Econometrics Dimensions_of_Quality
 
On FDA’s Guidance on Pharmaceutical Process Validation (2011)l
On FDA’s Guidance on Pharmaceutical Process Validation (2011)lOn FDA’s Guidance on Pharmaceutical Process Validation (2011)l
On FDA’s Guidance on Pharmaceutical Process Validation (2011)l
 
Critical Path Initiative Challenges: FDA ACPS Meeting 19 October 2004
Critical Path Initiative Challenges: FDA ACPS Meeting 19 October 2004Critical Path Initiative Challenges: FDA ACPS Meeting 19 October 2004
Critical Path Initiative Challenges: FDA ACPS Meeting 19 October 2004
 
Sharpen your Unique Sensing Proclivity: Dissolution is a process in mind and ...
Sharpen your Unique Sensing Proclivity: Dissolution is a process in mind and ...Sharpen your Unique Sensing Proclivity: Dissolution is a process in mind and ...
Sharpen your Unique Sensing Proclivity: Dissolution is a process in mind and ...
 
Defining a Commercially Viable Product | Manas Kanungo | Lunch & Learn
Defining a Commercially Viable Product | Manas Kanungo | Lunch & Learn Defining a Commercially Viable Product | Manas Kanungo | Lunch & Learn
Defining a Commercially Viable Product | Manas Kanungo | Lunch & Learn
 
CHIR Best Brains Exchange 22 January 2016
CHIR Best Brains Exchange 22 January 2016CHIR Best Brains Exchange 22 January 2016
CHIR Best Brains Exchange 22 January 2016
 
SMi Group's Injectable Drug Delivery 2018 conference
SMi Group's Injectable Drug Delivery 2018 conferenceSMi Group's Injectable Drug Delivery 2018 conference
SMi Group's Injectable Drug Delivery 2018 conference
 
SMi Group's 3rd annual Prefilled Syringes East Coast 2016
SMi Group's 3rd annual Prefilled Syringes East Coast 2016SMi Group's 3rd annual Prefilled Syringes East Coast 2016
SMi Group's 3rd annual Prefilled Syringes East Coast 2016
 

Similar to P 141 pre-filled syringes america revised

SMi Group's Pre-Filled Syringes and Injectable Drug Devices 2020
SMi Group's Pre-Filled Syringes and Injectable Drug Devices 2020SMi Group's Pre-Filled Syringes and Injectable Drug Devices 2020
SMi Group's Pre-Filled Syringes and Injectable Drug Devices 2020Dale Butler
 
SMi Group's Pre Filled Syringes West Coast 2016 conference
SMi Group's Pre Filled Syringes West Coast 2016 conferenceSMi Group's Pre Filled Syringes West Coast 2016 conference
SMi Group's Pre Filled Syringes West Coast 2016 conferenceDale Butler
 
Pre filled syringes americas
Pre filled syringes americasPre filled syringes americas
Pre filled syringes americasYulia Rotar
 
SMi Group's Prefilled Syringes West Coast 2019 conference
SMi Group's Prefilled Syringes West Coast 2019 conferenceSMi Group's Prefilled Syringes West Coast 2019 conference
SMi Group's Prefilled Syringes West Coast 2019 conferenceDale Butler
 
SMi Group's Pre-filled Syringes West Coast 2020 conference
SMi Group's Pre-filled Syringes West Coast 2020 conferenceSMi Group's Pre-filled Syringes West Coast 2020 conference
SMi Group's Pre-filled Syringes West Coast 2020 conferenceDale Butler
 
Pre-Filled Syringes West Coast 2017
Pre-Filled Syringes West Coast 2017Pre-Filled Syringes West Coast 2017
Pre-Filled Syringes West Coast 2017Teri Arri
 
SMi Group's 2nd annual Pre-filled Syringes West Coast 2017
SMi Group's 2nd annual Pre-filled Syringes West Coast 2017SMi Group's 2nd annual Pre-filled Syringes West Coast 2017
SMi Group's 2nd annual Pre-filled Syringes West Coast 2017Dale Butler
 
SMi Group's Prefilled Syringes East Coast 2018 conference
SMi Group's Prefilled Syringes East Coast 2018 conferenceSMi Group's Prefilled Syringes East Coast 2018 conference
SMi Group's Prefilled Syringes East Coast 2018 conferenceDale Butler
 
5th Annual Pre-Filled Syringes East Coast
5th Annual Pre-Filled Syringes East Coast5th Annual Pre-Filled Syringes East Coast
5th Annual Pre-Filled Syringes East CoastTeri Arri
 
Pre-Filled Syringes West Coast 2017
Pre-Filled Syringes West Coast 2017Pre-Filled Syringes West Coast 2017
Pre-Filled Syringes West Coast 2017Fateja Begum
 
Biomanufacturing in China: Technologies and Facility Design
Biomanufacturing in China: Technologies and Facility DesignBiomanufacturing in China: Technologies and Facility Design
Biomanufacturing in China: Technologies and Facility DesignRita Barry
 
SMi Group's PreFilled Syringes Americas conference & exhibition
SMi Group's PreFilled Syringes Americas conference & exhibitionSMi Group's PreFilled Syringes Americas conference & exhibition
SMi Group's PreFilled Syringes Americas conference & exhibitionDale Butler
 
SMi Group's Adaptive Designs in Clinical Trials 2019
SMi Group's Adaptive Designs in Clinical Trials 2019 SMi Group's Adaptive Designs in Clinical Trials 2019
SMi Group's Adaptive Designs in Clinical Trials 2019 Dale Butler
 
SMi Group's Pre-filled Syringes East Coast 2019
SMi Group's Pre-filled Syringes East Coast 2019SMi Group's Pre-filled Syringes East Coast 2019
SMi Group's Pre-filled Syringes East Coast 2019Dale Butler
 
SMi Group's Pre-Filled Syringes Conference & Exhibition
SMi Group's Pre-Filled Syringes Conference & ExhibitionSMi Group's Pre-Filled Syringes Conference & Exhibition
SMi Group's Pre-Filled Syringes Conference & ExhibitionDale Butler
 
Avoca Quality Consortium Meeting Topics Day 2, May 7
Avoca Quality Consortium Meeting Topics Day 2, May 7Avoca Quality Consortium Meeting Topics Day 2, May 7
Avoca Quality Consortium Meeting Topics Day 2, May 7The Avoca Group
 
SMi Group's 9th annual Pre-filled Syringes Europe 2017
SMi Group's 9th annual Pre-filled Syringes Europe 2017 SMi Group's 9th annual Pre-filled Syringes Europe 2017
SMi Group's 9th annual Pre-filled Syringes Europe 2017 Dale Butler
 
SMi Group's Pre-Filled Syringes East Coast 2016 conference
SMi Group's Pre-Filled Syringes East Coast 2016 conferenceSMi Group's Pre-Filled Syringes East Coast 2016 conference
SMi Group's Pre-Filled Syringes East Coast 2016 conferenceDale Butler
 
Ophthalmic Drugs 2017
Ophthalmic Drugs 2017Ophthalmic Drugs 2017
Ophthalmic Drugs 2017Pavan Solanki
 

Similar to P 141 pre-filled syringes america revised (20)

SMi Group's Pre-Filled Syringes and Injectable Drug Devices 2020
SMi Group's Pre-Filled Syringes and Injectable Drug Devices 2020SMi Group's Pre-Filled Syringes and Injectable Drug Devices 2020
SMi Group's Pre-Filled Syringes and Injectable Drug Devices 2020
 
SMi Group's Pre Filled Syringes West Coast 2016 conference
SMi Group's Pre Filled Syringes West Coast 2016 conferenceSMi Group's Pre Filled Syringes West Coast 2016 conference
SMi Group's Pre Filled Syringes West Coast 2016 conference
 
Pre filled syringes americas
Pre filled syringes americasPre filled syringes americas
Pre filled syringes americas
 
SMi Group's Prefilled Syringes West Coast 2019 conference
SMi Group's Prefilled Syringes West Coast 2019 conferenceSMi Group's Prefilled Syringes West Coast 2019 conference
SMi Group's Prefilled Syringes West Coast 2019 conference
 
SMi Group's Pre-filled Syringes West Coast 2020 conference
SMi Group's Pre-filled Syringes West Coast 2020 conferenceSMi Group's Pre-filled Syringes West Coast 2020 conference
SMi Group's Pre-filled Syringes West Coast 2020 conference
 
Pre-Filled Syringes West Coast 2017
Pre-Filled Syringes West Coast 2017Pre-Filled Syringes West Coast 2017
Pre-Filled Syringes West Coast 2017
 
SMi Group's 2nd annual Pre-filled Syringes West Coast 2017
SMi Group's 2nd annual Pre-filled Syringes West Coast 2017SMi Group's 2nd annual Pre-filled Syringes West Coast 2017
SMi Group's 2nd annual Pre-filled Syringes West Coast 2017
 
SMi Group's Prefilled Syringes East Coast 2018 conference
SMi Group's Prefilled Syringes East Coast 2018 conferenceSMi Group's Prefilled Syringes East Coast 2018 conference
SMi Group's Prefilled Syringes East Coast 2018 conference
 
5th Annual Pre-Filled Syringes East Coast
5th Annual Pre-Filled Syringes East Coast5th Annual Pre-Filled Syringes East Coast
5th Annual Pre-Filled Syringes East Coast
 
Pre-Filled Syringes West Coast 2017
Pre-Filled Syringes West Coast 2017Pre-Filled Syringes West Coast 2017
Pre-Filled Syringes West Coast 2017
 
Biomanufacturing in China: Technologies and Facility Design
Biomanufacturing in China: Technologies and Facility DesignBiomanufacturing in China: Technologies and Facility Design
Biomanufacturing in China: Technologies and Facility Design
 
SMi Group's PreFilled Syringes Americas conference & exhibition
SMi Group's PreFilled Syringes Americas conference & exhibitionSMi Group's PreFilled Syringes Americas conference & exhibition
SMi Group's PreFilled Syringes Americas conference & exhibition
 
SMi Group's Adaptive Designs in Clinical Trials 2019
SMi Group's Adaptive Designs in Clinical Trials 2019 SMi Group's Adaptive Designs in Clinical Trials 2019
SMi Group's Adaptive Designs in Clinical Trials 2019
 
SMi Group's Pre-filled Syringes East Coast 2019
SMi Group's Pre-filled Syringes East Coast 2019SMi Group's Pre-filled Syringes East Coast 2019
SMi Group's Pre-filled Syringes East Coast 2019
 
SMi Group's Pre-Filled Syringes Conference & Exhibition
SMi Group's Pre-Filled Syringes Conference & ExhibitionSMi Group's Pre-Filled Syringes Conference & Exhibition
SMi Group's Pre-Filled Syringes Conference & Exhibition
 
Avoca Quality Consortium Meeting Topics Day 2, May 7
Avoca Quality Consortium Meeting Topics Day 2, May 7Avoca Quality Consortium Meeting Topics Day 2, May 7
Avoca Quality Consortium Meeting Topics Day 2, May 7
 
SMi Group's 9th annual Pre-filled Syringes Europe 2017
SMi Group's 9th annual Pre-filled Syringes Europe 2017 SMi Group's 9th annual Pre-filled Syringes Europe 2017
SMi Group's 9th annual Pre-filled Syringes Europe 2017
 
2nd Annual NPD Agenda
2nd Annual NPD Agenda2nd Annual NPD Agenda
2nd Annual NPD Agenda
 
SMi Group's Pre-Filled Syringes East Coast 2016 conference
SMi Group's Pre-Filled Syringes East Coast 2016 conferenceSMi Group's Pre-Filled Syringes East Coast 2016 conference
SMi Group's Pre-Filled Syringes East Coast 2016 conference
 
Ophthalmic Drugs 2017
Ophthalmic Drugs 2017Ophthalmic Drugs 2017
Ophthalmic Drugs 2017
 

More from Alia Malick

Pharmaceutical microbiology west coast
Pharmaceutical microbiology west coastPharmaceutical microbiology west coast
Pharmaceutical microbiology west coastAlia Malick
 
P 215 peptides final
P 215 peptides finalP 215 peptides final
P 215 peptides finalAlia Malick
 
P 156 cold chain distribution flyer
P 156 cold chain distribution flyerP 156 cold chain distribution flyer
P 156 cold chain distribution flyerAlia Malick
 
Helicopter technology eastern europe 2015.brochure.
Helicopter technology eastern europe 2015.brochure.Helicopter technology eastern europe 2015.brochure.
Helicopter technology eastern europe 2015.brochure.Alia Malick
 
Helicopter technology eastern europe 2015.brochure.
Helicopter technology eastern europe 2015.brochure.Helicopter technology eastern europe 2015.brochure.
Helicopter technology eastern europe 2015.brochure.Alia Malick
 
E 060 oil gas cyber security north america
E 060 oil gas cyber security north americaE 060 oil gas cyber security north america
E 060 oil gas cyber security north americaAlia Malick
 
Helicopter technology eastern europe 2015.brochure.
 Helicopter technology eastern europe 2015.brochure. Helicopter technology eastern europe 2015.brochure.
Helicopter technology eastern europe 2015.brochure.Alia Malick
 
E 060 oil gas cyber security north america
E 060 oil gas cyber security north americaE 060 oil gas cyber security north america
E 060 oil gas cyber security north americaAlia Malick
 
E 060 oil gas cyber security north america
E 060 oil gas cyber security north americaE 060 oil gas cyber security north america
E 060 oil gas cyber security north americaAlia Malick
 
D 079 helicopter technology eastern europe 2015.brochure.compressed
D 079 helicopter technology eastern europe 2015.brochure.compressedD 079 helicopter technology eastern europe 2015.brochure.compressed
D 079 helicopter technology eastern europe 2015.brochure.compressedAlia Malick
 

More from Alia Malick (11)

Pharmaceutical microbiology west coast
Pharmaceutical microbiology west coastPharmaceutical microbiology west coast
Pharmaceutical microbiology west coast
 
admet
admet admet
admet
 
P 215 peptides final
P 215 peptides finalP 215 peptides final
P 215 peptides final
 
P 156 cold chain distribution flyer
P 156 cold chain distribution flyerP 156 cold chain distribution flyer
P 156 cold chain distribution flyer
 
Helicopter technology eastern europe 2015.brochure.
Helicopter technology eastern europe 2015.brochure.Helicopter technology eastern europe 2015.brochure.
Helicopter technology eastern europe 2015.brochure.
 
Helicopter technology eastern europe 2015.brochure.
Helicopter technology eastern europe 2015.brochure.Helicopter technology eastern europe 2015.brochure.
Helicopter technology eastern europe 2015.brochure.
 
E 060 oil gas cyber security north america
E 060 oil gas cyber security north americaE 060 oil gas cyber security north america
E 060 oil gas cyber security north america
 
Helicopter technology eastern europe 2015.brochure.
 Helicopter technology eastern europe 2015.brochure. Helicopter technology eastern europe 2015.brochure.
Helicopter technology eastern europe 2015.brochure.
 
E 060 oil gas cyber security north america
E 060 oil gas cyber security north americaE 060 oil gas cyber security north america
E 060 oil gas cyber security north america
 
E 060 oil gas cyber security north america
E 060 oil gas cyber security north americaE 060 oil gas cyber security north america
E 060 oil gas cyber security north america
 
D 079 helicopter technology eastern europe 2015.brochure.compressed
D 079 helicopter technology eastern europe 2015.brochure.compressedD 079 helicopter technology eastern europe 2015.brochure.compressed
D 079 helicopter technology eastern europe 2015.brochure.compressed
 

Recently uploaded

Software Engineering Methodologies (overview)
Software Engineering Methodologies (overview)Software Engineering Methodologies (overview)
Software Engineering Methodologies (overview)eniolaolutunde
 
Incoming and Outgoing Shipments in 1 STEP Using Odoo 17
Incoming and Outgoing Shipments in 1 STEP Using Odoo 17Incoming and Outgoing Shipments in 1 STEP Using Odoo 17
Incoming and Outgoing Shipments in 1 STEP Using Odoo 17Celine George
 
How to Make a Pirate ship Primary Education.pptx
How to Make a Pirate ship Primary Education.pptxHow to Make a Pirate ship Primary Education.pptx
How to Make a Pirate ship Primary Education.pptxmanuelaromero2013
 
Employee wellbeing at the workplace.pptx
Employee wellbeing at the workplace.pptxEmployee wellbeing at the workplace.pptx
Employee wellbeing at the workplace.pptxNirmalaLoungPoorunde1
 
Introduction to ArtificiaI Intelligence in Higher Education
Introduction to ArtificiaI Intelligence in Higher EducationIntroduction to ArtificiaI Intelligence in Higher Education
Introduction to ArtificiaI Intelligence in Higher Educationpboyjonauth
 
भारत-रोम व्यापार.pptx, Indo-Roman Trade,
भारत-रोम व्यापार.pptx, Indo-Roman Trade,भारत-रोम व्यापार.pptx, Indo-Roman Trade,
भारत-रोम व्यापार.pptx, Indo-Roman Trade,Virag Sontakke
 
POINT- BIOCHEMISTRY SEM 2 ENZYMES UNIT 5.pptx
POINT- BIOCHEMISTRY SEM 2 ENZYMES UNIT 5.pptxPOINT- BIOCHEMISTRY SEM 2 ENZYMES UNIT 5.pptx
POINT- BIOCHEMISTRY SEM 2 ENZYMES UNIT 5.pptxSayali Powar
 
Earth Day Presentation wow hello nice great
Earth Day Presentation wow hello nice greatEarth Day Presentation wow hello nice great
Earth Day Presentation wow hello nice greatYousafMalik24
 
Types of Journalistic Writing Grade 8.pptx
Types of Journalistic Writing Grade 8.pptxTypes of Journalistic Writing Grade 8.pptx
Types of Journalistic Writing Grade 8.pptxEyham Joco
 
Computed Fields and api Depends in the Odoo 17
Computed Fields and api Depends in the Odoo 17Computed Fields and api Depends in the Odoo 17
Computed Fields and api Depends in the Odoo 17Celine George
 
Final demo Grade 9 for demo Plan dessert.pptx
Final demo Grade 9 for demo Plan dessert.pptxFinal demo Grade 9 for demo Plan dessert.pptx
Final demo Grade 9 for demo Plan dessert.pptxAvyJaneVismanos
 
CARE OF CHILD IN INCUBATOR..........pptx
CARE OF CHILD IN INCUBATOR..........pptxCARE OF CHILD IN INCUBATOR..........pptx
CARE OF CHILD IN INCUBATOR..........pptxGaneshChakor2
 
Hierarchy of management that covers different levels of management
Hierarchy of management that covers different levels of managementHierarchy of management that covers different levels of management
Hierarchy of management that covers different levels of managementmkooblal
 
Roles & Responsibilities in Pharmacovigilance
Roles & Responsibilities in PharmacovigilanceRoles & Responsibilities in Pharmacovigilance
Roles & Responsibilities in PharmacovigilanceSamikshaHamane
 
call girls in Kamla Market (DELHI) 🔝 >༒9953330565🔝 genuine Escort Service 🔝✔️✔️
call girls in Kamla Market (DELHI) 🔝 >༒9953330565🔝 genuine Escort Service 🔝✔️✔️call girls in Kamla Market (DELHI) 🔝 >༒9953330565🔝 genuine Escort Service 🔝✔️✔️
call girls in Kamla Market (DELHI) 🔝 >༒9953330565🔝 genuine Escort Service 🔝✔️✔️9953056974 Low Rate Call Girls In Saket, Delhi NCR
 
ECONOMIC CONTEXT - PAPER 1 Q3: NEWSPAPERS.pptx
ECONOMIC CONTEXT - PAPER 1 Q3: NEWSPAPERS.pptxECONOMIC CONTEXT - PAPER 1 Q3: NEWSPAPERS.pptx
ECONOMIC CONTEXT - PAPER 1 Q3: NEWSPAPERS.pptxiammrhaywood
 
Historical philosophical, theoretical, and legal foundations of special and i...
Historical philosophical, theoretical, and legal foundations of special and i...Historical philosophical, theoretical, and legal foundations of special and i...
Historical philosophical, theoretical, and legal foundations of special and i...jaredbarbolino94
 
Capitol Tech U Doctoral Presentation - April 2024.pptx
Capitol Tech U Doctoral Presentation - April 2024.pptxCapitol Tech U Doctoral Presentation - April 2024.pptx
Capitol Tech U Doctoral Presentation - April 2024.pptxCapitolTechU
 

Recently uploaded (20)

Software Engineering Methodologies (overview)
Software Engineering Methodologies (overview)Software Engineering Methodologies (overview)
Software Engineering Methodologies (overview)
 
Incoming and Outgoing Shipments in 1 STEP Using Odoo 17
Incoming and Outgoing Shipments in 1 STEP Using Odoo 17Incoming and Outgoing Shipments in 1 STEP Using Odoo 17
Incoming and Outgoing Shipments in 1 STEP Using Odoo 17
 
9953330565 Low Rate Call Girls In Rohini Delhi NCR
9953330565 Low Rate Call Girls In Rohini  Delhi NCR9953330565 Low Rate Call Girls In Rohini  Delhi NCR
9953330565 Low Rate Call Girls In Rohini Delhi NCR
 
How to Make a Pirate ship Primary Education.pptx
How to Make a Pirate ship Primary Education.pptxHow to Make a Pirate ship Primary Education.pptx
How to Make a Pirate ship Primary Education.pptx
 
ESSENTIAL of (CS/IT/IS) class 06 (database)
ESSENTIAL of (CS/IT/IS) class 06 (database)ESSENTIAL of (CS/IT/IS) class 06 (database)
ESSENTIAL of (CS/IT/IS) class 06 (database)
 
Employee wellbeing at the workplace.pptx
Employee wellbeing at the workplace.pptxEmployee wellbeing at the workplace.pptx
Employee wellbeing at the workplace.pptx
 
Introduction to ArtificiaI Intelligence in Higher Education
Introduction to ArtificiaI Intelligence in Higher EducationIntroduction to ArtificiaI Intelligence in Higher Education
Introduction to ArtificiaI Intelligence in Higher Education
 
भारत-रोम व्यापार.pptx, Indo-Roman Trade,
भारत-रोम व्यापार.pptx, Indo-Roman Trade,भारत-रोम व्यापार.pptx, Indo-Roman Trade,
भारत-रोम व्यापार.pptx, Indo-Roman Trade,
 
POINT- BIOCHEMISTRY SEM 2 ENZYMES UNIT 5.pptx
POINT- BIOCHEMISTRY SEM 2 ENZYMES UNIT 5.pptxPOINT- BIOCHEMISTRY SEM 2 ENZYMES UNIT 5.pptx
POINT- BIOCHEMISTRY SEM 2 ENZYMES UNIT 5.pptx
 
Earth Day Presentation wow hello nice great
Earth Day Presentation wow hello nice greatEarth Day Presentation wow hello nice great
Earth Day Presentation wow hello nice great
 
Types of Journalistic Writing Grade 8.pptx
Types of Journalistic Writing Grade 8.pptxTypes of Journalistic Writing Grade 8.pptx
Types of Journalistic Writing Grade 8.pptx
 
Computed Fields and api Depends in the Odoo 17
Computed Fields and api Depends in the Odoo 17Computed Fields and api Depends in the Odoo 17
Computed Fields and api Depends in the Odoo 17
 
Final demo Grade 9 for demo Plan dessert.pptx
Final demo Grade 9 for demo Plan dessert.pptxFinal demo Grade 9 for demo Plan dessert.pptx
Final demo Grade 9 for demo Plan dessert.pptx
 
CARE OF CHILD IN INCUBATOR..........pptx
CARE OF CHILD IN INCUBATOR..........pptxCARE OF CHILD IN INCUBATOR..........pptx
CARE OF CHILD IN INCUBATOR..........pptx
 
Hierarchy of management that covers different levels of management
Hierarchy of management that covers different levels of managementHierarchy of management that covers different levels of management
Hierarchy of management that covers different levels of management
 
Roles & Responsibilities in Pharmacovigilance
Roles & Responsibilities in PharmacovigilanceRoles & Responsibilities in Pharmacovigilance
Roles & Responsibilities in Pharmacovigilance
 
call girls in Kamla Market (DELHI) 🔝 >༒9953330565🔝 genuine Escort Service 🔝✔️✔️
call girls in Kamla Market (DELHI) 🔝 >༒9953330565🔝 genuine Escort Service 🔝✔️✔️call girls in Kamla Market (DELHI) 🔝 >༒9953330565🔝 genuine Escort Service 🔝✔️✔️
call girls in Kamla Market (DELHI) 🔝 >༒9953330565🔝 genuine Escort Service 🔝✔️✔️
 
ECONOMIC CONTEXT - PAPER 1 Q3: NEWSPAPERS.pptx
ECONOMIC CONTEXT - PAPER 1 Q3: NEWSPAPERS.pptxECONOMIC CONTEXT - PAPER 1 Q3: NEWSPAPERS.pptx
ECONOMIC CONTEXT - PAPER 1 Q3: NEWSPAPERS.pptx
 
Historical philosophical, theoretical, and legal foundations of special and i...
Historical philosophical, theoretical, and legal foundations of special and i...Historical philosophical, theoretical, and legal foundations of special and i...
Historical philosophical, theoretical, and legal foundations of special and i...
 
Capitol Tech U Doctoral Presentation - April 2024.pptx
Capitol Tech U Doctoral Presentation - April 2024.pptxCapitol Tech U Doctoral Presentation - April 2024.pptx
Capitol Tech U Doctoral Presentation - April 2024.pptx
 

P 141 pre-filled syringes america revised

  • 1. BUSINESS BENEFITS FOR 2015: • LISTEN to keynote addresses from the leaders in human factors engineering with expert input on reaching certain patient populations, considerations and compliance in device design and how can we ensure the drug product is administered safely and effectively • LEARN about the critical issues surrounding safety assessments of pre-filled syringes from extractables and leachables to sterility and needle stick prevention requirements – NEW FOR 2015 • ENHANCE your understanding of labelling and pricing considerations with the competitive market for biosimilars set to storm with patent expiries due • ASSESS the future of pre-filled syringes with case study led presentations addressing the challenges faced with parenteral packaging innovations and reviewing the strategies needed to overcome the hurdles with importance insights into autoinjectors and pens • ADDRESS the use of lyophilisation in pre-filled syringes, is this the future vision? SMi presents its 2nd annual conference and exhibition on... PLUS TWO INTERACTIVE HALF-DAY POST-CONFERENCE WORKSHOPS Wednesday 29th April 2015, Renaissance Woodbridge Hotel, Iselin, New Jersey, USA 27 - 28 APRIL 2015 Assessing the future of pre-filled syringes to improve innovation and device development Renaissance Woodbridge Hotel, Iselin, New Jersey, USA Pre-Filled Syringes America www.pfsamericas.com BOOK BY 27TH FEBRUARY AND SAVE $100 Register online or call +448709090711 to speak to an account executive "Excellent, informative and good quality" Delegate 2014 Advanced Delivery Systems to Enable Personalised Medicines Workshop Leaders: Ravi S. Harapanhalli, Vice President, ParExel and Mr. Sall, Principal Consultant, ParExel 8.30am – 12.30pm Will Drug Delivery in Coming Days be an Integral Part of DDM? - Diagnose, Deliver and Monitor Workshop Leaders: Chanderkanth Gautham, Domain Lead of Medical Device Team, Beroe Inc. and Saikrishna Garrepalli, Procurement Management Representative, Beroe Inc. 1.30pm – 5.30pm CHAIRS FOR 2015: Ravi Harapanhalli, Vice President, ParExel William Beierschmitt, Research Fellow, Drug Safety Research and Development, Pfizer Inc. KEY SPEAKERS FOR 2015: • Natalia Mazaeva, Usability Leader, Sanofi • Stephen Barat, Executive Director, Forest Laboratories, a subsidiary of Actavis • Ed Israelski, Director of Human Factors, AbbVie • Scott Brown, Device Development Lead, Merck • Li-Chun Tsou, Global Device Technical Director, AstraZeneca Pharmaceuticals • Kiran Singh, Associate Director, Sandoz • Michel Mikhail, Former Chief Regulatory Officer, Executive Vice President, Global Regulatory - Governmental Relations, Fresenius Kabi NV/SA • Mark Tsai, Principal Engineer, Drug Delivery, Janssen Pharmaceuticals Plus many more... BOOK BY 27TH FEBRUARY AND SAVE $100 @SMIPHARM #USAPFSSMI Sponsored by
  • 2. Pharmaceutical industry’s perspectives: • Drug stability (minimize drug-syringe interactions by mitigating leachables and extractables, flakes (lamellae) or deposits, glass fragments, and lubricant particles) • Syringe durability • Cost Manufacturer’s perspectives: • Simplified manufacturing/assembly processes to mitigate batch variances • Consider stringent sterilization and packaging processes • Compliance of the mandatory "safety" PFS Healthcare industry’s perspectives: • Avoid needlestick injuries • User-friendly • Eco-friendly (minimum residual of medicine, recyclable device material) Patient's perspectives: • User-friendly (convenience and safety in preparation and self-administration) • Eco-friendly (minimum residual of medicine, recyclable device material) • Price-friendly Pre-Filled Syringes America Day One | Monday 27th April 2015 8.30 Registration & Coffee 9.00 Chair’s Opening Remarks William Beierschmitt, Research Fellow, Drug Safety Research and Development, Pfizer Inc. HUMAN FACTOR STUDIES OPENING ADDRESS 9.10 The importance of the patient and how each individual differs • Reviewing the patient populations and the needs of certain individuals in device design • How can we enhance products to ensure they’re specifically designed for the patient’s needs? • Evaluating the best outcome for the patients, what factors should be considered Ed Israelski, Director of Human Factors, AbbVie 9.50 Success Criteria – How can the FDA’s requirements be met? • Demonstrating safety and effectiveness in the hands of the user • Reviewing the design requirements for validation purposes • Are the customer requirements being met in design transfer? • Post –market surveillance – What observations can be made? Natalia Mazaeva, Sr. Usability Leader, Global Usability and Risk Management, Device Development, Sanofi CASE STUDY 10.30 End user needs and perspectives for device assembly End User Needs and Perspectives are critical for final device delivery. This presentation will address the injectable device trends and flexibility required for an assembly machine to adapt to new market challenges while incorporating the ‘Human Factor’. This presentation will also focus on recent Regulatory updates (11608) for Combination Products The lecture will show: • Injectable Device Trends • Human Factor - Increased focus on safety, usability and handling studies • Flexible standardized platforms to handle customized assembly of pens and auto-injectors • Gentle handling of the filled glass container during assembly of the device using proven liquid fill finish handling technology Dena Flamm, Product Manager, Robert Bosch GmbH 11.10 Morning Coffee KEYNOTE ADDRESS 11.40 Convenience and compliance: empower the user through good design • Reducing concerns by the end user is critical, what steps can be taken to increase patient satisfaction? • Precision and safety go hand in hand, let’s address considerations to ensure the product designed is safe and effective • How do we ensure the patient receives the exact dose intended? Ben Bartfeld, Human Factors and Industrial Design Consultant, Otsuka Consultant Pharmaceutical Companies 12.20 What makes a pre-filled syringes ergonomic? • Addressing the importance of human factor studies in device development • Assessing the possibilities to ensure the drug product is administered safely and effectively • Working with clients concentrating on the design based strategies Saikrishna Garrepalli, Procurement Management Representative, Beroe Inc. 1.00 The New Frontier: Advancing the quality and functionality of drug delivery Paul Chao, Core Team Leader, R&D Staff Engineer and Justin Wright, Senior Director, Strategic Innovation, BD Medical - Pharmaceutical Systems 1.40 BREAKOUT SESSION & OPPORTUNTY TO NETWORK PRE-LUNCH • Are we seeing a growing trend in drug delivery being administered outside traditional medical settings? • How can we ensure this is safe? Host: William Beierschmitt, Research Fellow, Drug Safety Research and Development, Pfizer Inc. 2.00 Networking Lunch CRITICAL ISSUES: SAFETY ASSESSMENT 3.00 Safety Evaluation of Leachables for Pre-Filled Syringe Drug Products • Background on leachables and pre-filled syringes • Why safety assessment for leachables is necessary • How to approach and conduct a leachable safety evaluation • Current best practice recommendations and examples Stephen Barat, Executive Director, Forest Laboratories, a subsidiary of Actavis 3.40 The Risk Assessment of Extractables - A Toxicological Window of Opportunity • Ensuring compatibility of the profile of the pre-filled syringe with the biologic • Avoiding changes in product quality • Material selection and final assessment of leachables William Beierschmitt, Research Fellow, Drug Safety Research and Development, Pfizer Inc. 4.20 Innovating for safety: Let's be sharp to protect end-users with safe injectable devices • Needle stick injuries concerns and regulations • Syringes breakage concerns: - plastic as a glass alternative? - injection devices to reduce stress on glass prefilled syringes • Examples from prefilled syringes safety devices, implanters and auto-injectors • Balance value propositions for the patients and the pharmaceutical perspective Isabelle Delcroix, Business Development Director, Nemera 5.00 Afternoon Tea 5.30 CASE STUDY Identifying incompatibility causes and challenges • Assessing drug delivery studies and reflecting on the impact of incompatibility • Assessing the specific fit of LAV valves and specific issues surrounding prefilled syringe design Kiran Singh, Associate Director, Sandoz GmbH 6.10 Assessing the safety of needle devices • Looking at the global demand of safety needle devices • What necessary steps should be taken to ensure a successful safety pre-filled syringe • Creative design of safety pre-filled syringes Pei-Yang Phillip Hsu, Chief Executive Officer, SaferMed Technologies Co. Ltd. 6.50 ROUND TABLE DISCUSSION AND NETWORKING OPPORTUNITY • Discussing the safety challenges surrounding pre-filled syringes Host: Pei-Yang Phillip Hsu, Chief Executive Officer, SaferMed Technologies Co. Ltd 7.20 Chair's Closing Remarks and Close of Day One NEW FOR 2015! NEW FOR 2015! Register online at: www.pfsamericas.com • Alternatively fax yo
  • 3. Pre-Filled Syringes America Day Two | Tuesday 28th April 2015 8.30 Registration & Coffee 9.00 Chair’s Opening Remarks Ravi S. Harapanhalli, Vice President, ParExel ENHANCING DEVICE DEVELOPMENT OPENING ADDRESS 9.10 Getting to market: Regulatory perspective • Defining a pre-filled syringe as a product or device and its impact on regulatory approval • Insight into the FDA’s current thoughts Ravi S. Harapanhalli, Vice President, ParExel, former FDA Senior Executive 9.50 Biosimilars and Delivery Devices…here we go! • Patent expiries for biologics are creating a new competitive market for biosimilars in particular Monoclonal antibodies • How to differentiate from the innovator with a device • Factors to Review: e.g. Interchangeability studies Michel Mikhail, Former Chief Regulatory Officer, Executive Vice President, Global Regulatory - Governmental Relations, Fresenius Kabi NV/SA 10.30 Room Temperature Sterilization of Pre-Filled Syringes • The need for sterilization of prefilled syringes to be administered in the sterile field • Sterilization using Nitrogen Dioxide for temperature sensitive products • Regulatory pathways for nitrogen dioxide sterilization Evan Goulet, Director, Sterilization Operations, Noxilizer, Inc. 11.00 Morning Coffee CASE STUDY 11.30 The partnership reviewed between a pharmaceutical company and the manufacturer/supplier • Overview of the relationship and how it was managed •An explanation on why the products have been developed Shun Ogawa, Research Manager, Mitsubishi Gas Chemical Company, Inc. 12.10 Combination Product Considerations- Starting with the End in Mind • Evolving trends for the pre-filled syringe and self-injection markets • Industry/Supplier partnership is key to successful development outcomes • Patient considerations and building strong product brands through innovation Royce Brockett, Senior Product Manager, West Pharmaceutical Services, Inc. ROUND TABLE DISCUSSION 12.50 The partnership reviewed between a pharmaceutical company and the manufacturer/supplier • Choosing a partner: What are the decision criteria? • Who owns what: Equipment, IP, regulatory requirements? • Managing the partnership Scott Brown, Executive Director/ Device Development Lead, Merck Research Laboratories 1.20 Networking Lunch KEYNOTE ADDRESS 2.20 Parenteral Device Strategy for Patient-Centric Therapeutics • Advantages and Constraints of Pre-filled Syringes in Designing Cutting Edge Devices • Global Design Control Process in Meeting Country Specific Regulatory Expectations • Concurrent Engineering Commercialization Model in Achieving Successful New Product Launch Li-Chun Tsou, Global Device Technical Director, AstraZeneca Pharmaceuticals 3.00 Product Line Management, sustaining activities • Engineering change plan • Product enhancement, material change, CAPA • Post market risk management • Design control, sustaining activities Mark Tsai, Principal Engineer, Cell Therapy, Janssen R&D 3.40 BREAKOUT SESSION & OPPORTUNTY TO NETWORK • Glass v Plastic • The advantages and disadvantages • Is once still more favourable, if so why? Discuss Host: Ravi Harapanhalli, Vice President, ParExel 4.20 Afternoon Tea CASE STUDY 4.50 Process Development studies to optimize process parameters and finalize presentation format Case studies included: • Development study to evaluate hold times on the filing line • Stopper movement studies to evaluate effect of headspace Aarti Gidh, Senior Scientific Investigator, GlaxoSmithKline 5.30 Electronics and Mobile Apps role in drug delivery and dosage adherence • How electronics and mobile apps in device development are going to affect dosage areas in the medical device space • Some of major development in patch front which has circuitry embedment and other innovative add on • Increasing penetration of electronics in drug delivery • Vision of leading device manufacturers and their take on electronics future • Role of mobile apps in complimenting the growth of electronics in device arena Chanderkanth Gautam, Domain Lead and Medical Device Community Leader, Beroe Inc. 6.10 Chairman’s Closing Remarks and Close of Day Two Official Platinum Media Partner NEW FOR 2015! NEW FOR 2015! NEW FOR 2015! Supported by ur registration to +44 (0)870 9090 712 or call +44 (0)870 9090 711 PHARMA • What worked (Existing Actions) Pharma companies sometimes use mono-layer plastic containers to prevent the below problems, but all of them don’t have enough oxygen barrier. • What could’ve been improved? (Existing Problems for Glass Container - Breakage - Heavy Weight - Difficulty of disposal - Protein Adsorption - Inorganic Extractable, etc. • Moving forward, what would you have done differently? (Future actions) Some antioxidizing agent might be used for injectable drugs. SUPPLIER • What worked (Existing solutions by suppliers) Some supplies provide mono- layer plastic containers instead of glass, but all of them don’t have enough oxygen barrier. • What could’ve been improved? - Oxygen Barrier • Moving forward, what would you have done differently? (Our solutions) - We developed an oxygen absorbing polymer. - We also developed 3 layers- containers - The oxygen absorbing polymer is used for the middle layer - COP which is well- known as a high moisture
  • 4. HALF-DAY POST CONFERENCE WORKSHOP AM Wednesday 29th April 2015 | 8.30am – 12.30pm | Renaissance Woodbridge Hotel, Iselin, New Jersey, USA Advanced Delivery Systems to Enable Personalised Medicines Workshop Leaders: Ravi S. Harapanhalli, Vice President, ParExel and Mr. Sall, Principal Consultant, ParExel Workshop overview: Run by one of the US’s leading figures in regulatory approval processes and drug delivery systems, Dr. Ravi Harapanhalli. This industry leading workshop will help you plan for smooth regulatory approvals and help with avoiding pitfalls that can cause expensive delays in taking your product to market. Who should attend this workshop: R&D Scientists, Regulatory Affairs, Device specialists, Formulators, Business Development Staff HALF-DAY POST CONFERENCE WORKSHOP PM Wednesday 29th April 2015 | 1.30pm – 5.30pm | Renaissance Woodbridge Hotel, Iselin, New Jersey, USA Will Drug Delivery in Coming Days be an Integral Part of DDM? - Diagnose, Deliver and Monitor Workshop Leaders: Chanderkanth Gautham, Domain Lead of Medical Device Team, Beroe Inc. and Saikrishna Garrepalli, Procurement Management Representative, Beroe Inc. Overview of workshop: Drug delivery device market would no longer exist as standalone entity. As healthcare longs to address all the solution through single gateway, technologies such electronic bandage, artificial pancreas pave their way into the market. They provide a holistic solution by diagnostic, delivering and monitoring. This is likely to be future of healthcare. Why you should attend this workshop: • To understand the platform that will be face of healthcare in coming days. • To understand how fast are new technologies are advancing in the space of Medtech,andhowconsiderablethesedeviceswereinaddressingthegapthe currently prevails will be the focus of the workshop. About the workshop hosts: Chanderkanth Gautham A Medical Device Procurement Management Representative (Sr. Research Analyst) with experiences in R&D, Human Factors, Contract Research Services facilitating Medical Devices, Pharmaceutical, Cosmetics and Herbal Companies with Product development, Regulatory and Post Marketing (Medical Affairs) and Business Development support activities across global regions. Saikrishna Garrepalli Procurement Management Representative (Sr. Research Analyst) of leading medical device companies, Sai has experience in R&D, Human Factors, Contract Research Services and regulatory pathways. Currently he is analyst at Medical device team at Beroe handles various client initiatives such as supplier relationship, negotiations and others. About Beroe Inc. Beroe is procurement pioneer which addresses USD 15 Billion+ spend of its clients globally. It carefully monitors the market for any sort of trend at supplier or buyers end. And is very instrumental in benchmarking markets and supplier capabilities across various facets of value chain ranging from design to manufacturing. beroeinc.com Programme 8.30 Registration & Coffee 9.00 Introductions and Opening Remarks 9.45 Session 1: Quality-by-Design in the development of drug delivery systems 10.30 Session 2: Regulatory pitfalls to avoid 11.00 Coffee break 11.30 Session 3: New combination product regulations and how to comply with them 12.00 Session 4: How to accelerate approval through FDA 12.30 End of Workshop Why you should attend this workshop: • Accelerate the time it takes to take your drug delivery system to market • Find out how to navigate new combination product guidelines • Assess the right time to start thinking about your drug delivery mechanism • Develop a strategy for product life cycle management by switching over to PFS • Understand how to apply the FDA Quality SystemRegulation to delivery device development • Know how to apply FDA Design Controls to delivery device development • Get to appreciate how to selection of a delivery device development partner • Perform risk analysis and Human Factors assessment About the workshop host: Dr. Ravi Harapanhalli advises bio/pharmaceutical companies on CMC regulatory strategies and Quality-by-Design approaches to medicinal product development and flexible regulatory approaches. About the workshop co-leader: Mr. Sall is a Principal Consultant with PAREXEL Consulting in Waltham, MA. PAREXEL provides clinical trial, clinical data management, medical and regulatory services to the pharmaceutical and medical device industries. About ParExel: Over the past 30 years, ParExel has developed significant expertise to assist clients in the worldwide pharmaceutical, biotechnology and medical device industries with the development and launch of their products in order to bring safe and effective treatments to the global marketplace for the patients who need them. Headquartered near Boston, Massachusetts, ParExel operates over 77 locations throughout more than 51 countries around the world, and has over 14,400 employees. www.parexel.com Programme 1.30 Registration and Coffee 2.00 Will drug delivery in coming days be integral part of DDM <diagnose, deliver and monitor> Areas Covered • Introduction on these developments • Some case studies indicating the inception of the trend • Will developments in non-invasive sensor based technologies and automatic modes of delivery increase inclination of patients and physicians to home care technologies. • Do acquisition of monitoring device companies by Medtech giants’ indicate bigger role of DDM platforms in future? 3.30 Coffee Break 4.00 Will artificial pancreas penetration in market pave way for non-conventional diabetic therapy? Areas to be covered • Will the aforementioned platform challenge the conventional, glucose measurement and injection therapy to a significant amount? • Does this mean that conventional modes insulin delivery via auto injectors, pen injectors now needs a massive scale up technology wise? • Who are those technology pioneers that need special mention on their recent developments in same space? 5.30 End of Workshop
  • 5. SPONSORED BY: SPONSORSHIP AND EXHIBITION OPPORTUNITIES SMi offer sponsorship, exhibition, advertising and branding packages, uniquely tailored to complement your company’s marketing strategy. Prime networking opportunities exist to entertain, enhance and expand your client base within the context of an independent discussion specific to your industry. Should you wish to join the increasing number of companies benefiting from sponsoring our conferences please call: Alia Malick on +44 (0) 20 7827 6168 or email: amalick@smi-online.co.uk Pre-Filled Syringes Americas BD Medical – Pharmaceutical Systems provides high-quality, customized, clinically-proven drug delivery systems to help pharmaceutical and biotechnology customers’ injectable drugs reach their full potential. BD offers a range of products, including glass and plastic prefillable syringes and a variety of systems for the self- administration of injectables. With a broad range of innovative systems and services, BD provides pharmaceutical companies with support and resources to help them achieve their goals. www.bd.com Bosch Packaging Technology is the world leader in the design and manufacture of pharmaceutical processing and packaging systems. Bosch offers a range of syringe filling systems in both nested and bulk styles of systems. Bosch also now offers syringe pen assembly systems and single use dosing systems with scalable solutions. With Bosch one supplier solutions are a real possibility. www.boschpackaging.com Ginolis provides automation solutions for manufacturing, laboratories and end-user instruments for medtech, pharmaceutical and diagnostic companies. Ginolis also develops customer-specific disposable platform solutions for high-volume applications. The company is privately owned and headquartered in Oulu, Finland, with a subsidiary in Uppsala, Sweden and a sales and service site in San Diego, California. http://ginolis.com/company-introduction Mitsubishi Gas Chemical (MGC) is well-known as an expert in unique polymers and oxygen absorbers. Based on our experience and expertise, MGC has successfully developed multilayer plastic vial and syringe with oxygen absorbing function. MGC believes they will be an only solution to replace glass with plastic. www.mgc.co.jp/eng Nemera is one of the world leaders in the design, development and manufacturing of drug delivery solutions. Its expertise covers all five modes of delivery: parenteral (injectors, pens, safety devices) and also ophthalmic (preservative free droppers), nasal, buccal, auricular (sprays pumps, etc.), pulmonary (inhalers), dermal and transdermal (dispensers). Nemera provides solutions for the pharmaceutical industry, including standard innovative products such as passive safety device for prefilled syringes Safe’n’Sound®, development of custom devices and contract manufacturing. www.nemera.net Noxilizer, Inc. provides a proprietary room temperature nitrogen dioxide sterilization technology that offers many benefits over traditional methods. NO2 sterilization has shorter cycles (approximately 2 hours including aeration), operates with/without vacuum and is easily installed—an ideal solution for prefilled syringes and drug-device combination products. Noxilizer provides contract sterilization services and sells sterilization equipment. Noxilizer Inc. was founded in 2004 and has offices in the US, United Kingdom, and Japan. www.noxilizer.com West works side by side with its healthcare partners from concept to the patient, designing and manufacturing packaging, diagnostic and delivery systems that promote the efficiency, reliability and safety of their products. Every day, West is leading the way with cutting-edge technologies and quality systems, a thorough understanding of global regulatory compliance, and an unmatched and growing knowledge base of relevant pharmaceutical product testing, development and packaging. Based in Exton, Pa., West supports its customers from sales, manufacturing, customer support and research and development locations in North and South America, Europe, Asia and Australia. www.westpharma.com Want to know how you can get involved? Interested in promoting your services to this market? Contact Julia Rotar, SMi Marketing on +44 (0) 207 827 6088, or email: jrotar@smi-online.co.uk WHO SHOULD ATTEND: Those involved in the following: • Pharma Development • Engineering • Manufacturing Technology • Biopharma Operations • Regulatory Affairs • Parenterals • Packaging • Formulation Aseptic • Device Development • Device Design • Labelling • Manufacturing • Drug Delivery • Formulation & Aseptic Filling Technologies • Chemistry Manufacture Controls (CMC) • Quality Assurance • Safe Medication Practice 11 2BREAKOUT SESSIONS 4CASE STUDIES LEADING PHARMA COMPANIES SPEAKING 2KEYNOTE ADDRESSES 100+ATTENDEES 2 ROUND TABLE DISCUSSIONS Attendee by Location USA 71% Europe 17% India 5% Canada 7% KEY HIGHLIGHTS:
  • 6. FAX your booking form to +44 (0) 870 9090 712 PHONE on +44 (0) 870 9090 711 POST your booking form to: Events Team, SMi Group Ltd, 2nd Floor South, Harling House, 47-51 Great Suffolk Street, London, SE1 0BS, UK PRE-FILLED SYRINGES AMERICA Conference: Monday 27th & Tuesday 28th April 2015, Renaissance Woodbridge Hotel, Iselin, New Jersey, USA Workshops: Wednesday 29th April 2015, USA 4 WAYS TO REGISTER www.pfsamericas.com If you have any further queries please call the Events Team on tel +44 (0) 870 9090 711 or you can email events@smi-online.co.uk Payment: If payment is not made at the time of booking, then an invoice will be issued and must be paid immediately and prior to the start of the event. If payment has not been received then credit card details will be requested and payment taken before entry to the event. Bookings within 7 days ofeventrequirepaymentonbooking.AccesstotheDocumentPortalwillnotbegivenuntilpayment has been received. Substitutions/Name Changes: If you are unable to attend you may nominate, in writing, another delegate to take your place at any time prior to the start of the event. Two or more delegates may not ‘share’ a place at an event. Please make separate bookings for each delegate. Cancellation: If you wish to cancel your attendance at an event and you are unable to send a substitute, then we will refund/credit 50% of the due fee less a £50 administration charge, providing that cancellation is made in writing and received at least 28 days prior to the start of the event. Regretfully cancellation after this time cannot be accepted. We will however provide the conferences documentation via the Document Portal to any delegate who has paid but is unable to attend for any reason. Due to the interactive nature of the Briefings we are not normally able to provide documentation in these circumstances. We cannot accept cancellations of orders placed for Documentation or the Document Portal as these are reproduced specifically to order. If we have to cancel the event for any reason, then we will make a full refund immediately, but disclaim any further liability. Alterations: It may become necessary for us to make alterations to the content, speakers, timing, venue or date of the event compared to the advertised programme. Data Protection: The SMi Group gathers personal data in accordance with the UK Data Protection Act 1998 and we may use this to contact you by telephone, fax, post or email to tell you about other products and services. Unless you tick here □we may also share your data with third parties offering complementary products or services. If you have any queries or want to update any of the data that we hold then please contact our Database Manager databasemanager@smi-online.co.uk or visit our website www.smi-online.co.uk/updates quoting the URN as detailed above your address on the attached letter. Unique Reference Number Our Reference LVP-141 Terms and Conditions of Booking DELEGATE DETAILS Please complete fully and clearly in capital letters. Please photocopy for additional delegates. Title: Forename: Surname: Job Title: Department/Division: Company/Organisation: Email: Company VAT Number: Address: Town/City: Post/Zip Code: Country: Direct Tel: Direct Fax: Mobile: Switchboard: Signature: Date: I agree to be bound by SMi's Terms and Conditions of Booking. ACCOUNTS DEPT Title: Forename: Surname: Email: Address (if different from above): Town/City: Post/Zip Code: Country: Direct Tel: Direct Fax: VENUE Renaissance Woodbridge Hotel, Iselin, New Jersey, USA □ Please contact me to book my hotel Alternatively call us on +44 (0) 870 9090 711, email: hotels@smi-online.co.uk or fax +44 (0) 870 9090 712 EARLY BIRD DISCOUNT Payment must be made to SMi Group Ltd, and received before the event, by one of the following methods quoting reference P-141 and the delegate’s name. Bookings made within 7 days of the event require payment on booking, methods of payment are below. Please indicate method of payment: A/C Name SMI GROUP LTD Sort Code 300009, Account Number 11775391 CCY USD □ Wire Transfer Lloyds TSB Bank plc, 39 Threadneedle Street, London, EC2R 8AU IBAN GB75LOYD30000911775391 BIC LOYDGB21013 □ Cheque We can only accept cheques in US Dollars. □ Credit Card □ Visa □ MasterCard □ American Express All credit card payments will be subject to standard credit card charges. Card No: □□□□ □□□□ □□□□ □□□□ Valid From □□/□□ Expiry Date □□/□□ CVV Number □□□□ 3 digit security on reverse of card, 4 digits for AMEX card Cardholder’s Name: Signature: Date: I agree to be bound by SMi's Terms and Conditions of Booking. Card Billing Address (If different from above): DOCUMENTATION I cannot attend but would like to purchase access to the following Document Portal/paper copy documentation Price Total □ Access to the conference documentation on the Document Portal £499.00 + VAT £598.80 □ The Conference Presentations – paper copy £499.00 - £499.00 (or only £300 if ordered with the Document Portal) PAYMENT VAT VAT at 20% is charged on Document Portal and literature distribution for all UK customers and for those EU Customers not supplying a registration number for their own country here. ______________________________________________________________________________________________ CONFERENCE PRICES I would like to attend: (Please tick as appropriate) Fee □ Conference & 2 Workshops $2997.00 □ Conference & 1 Workshop AM □ PM □ $2398.00 □ Conference only $1799.00 □ 2 Workshops only $1198.00 □ 1 Workshop only AM □ PM □ $599.00 PROMOTIONAL LITERATURE DISTRIBUTION □ Distribution of your company’s promotional literature to all conference attendees £999.00 + VAT £1198.80 The conference fee includes refreshments, lunch, conference papers, and access to the Document Portal. Presentations that are available for download will be subject to distribution rights by speakers. Please note that some presentations may not be available for download. Access information for the document portal will be sent to the e-mail address provided during registration. Details are sent within 24 hours post conference. □ Book by 27th February 2015 to receive $100 off the conference price