This document provides an agenda for the 5th annual Pre-Filled Syringes West Coast conference taking place June 15-17, 2020 in San Diego, CA. The conference will focus on innovations in device design and technology, advances in human factors engineering, combination product regulatory insights, and design controls and risk management. It will feature presentations from industry leaders at companies like Genentech and AstraZeneca as well as regulators from the FDA. There will also be two post-conference workshops on June 17th focusing on navigating FDA requirements for connected devices and digital health, and post-market safety reporting for combination products.
EPANDING THE CONTENT OF AN OUTLINE using notes.pptx
Optimising Device Design and Delivery at Pre-Filled Syringes West Coast 2020
1. HIGHLIGHTS FOR 2020:
• ENGAGE in case study presentations from leading
pharma and biotech companies on complex
product formulation and optimising device design to
aid delivery
• DISCUSS show to optimise current processes to align
with global regulatory updates
• DISCOVER human factors engineering best practices
through case study examples
• UNCOVER how industry is incorporating connectivity
and digital health to optimise the user experience
CHAIRS FOR 2020:
• Tina Rees, Associate Director – Human Factors, Ferring Pharmaceuticals
• Natalie Abts, Head of Human Factors Engineering, Genentech
FEATURED 2020 SPEAKERS INCLUDE:
• Jace Blackburn, Smart Device Engineer, Genentech
• Brittney Pachucki, Device Engineer, AstraZeneca
• Sarah Mollo, Combination Product Policy Analyst, Food and Drug
Administration
• Robert Ovadia, Engineer II, Genentech
• James P. Wabby, Executive Director, Regulatory Affairs – Device/
Combination Products, Allergan
• Tracy Hsu, Associate Director, Ionis Pharmaceuticals
• Khaudeja Bano, Sr. Medical Director, Abbott Molecular
• Mark DeStefano, Assoc. Dir. CPD – Feasibility, New Technology and
Prototyping Development, Teva
• Maggie Reiff, Manager, Device Engineering, Pfizer
• Jian Liu, Senior Scientist, Amgen
www.prefilled-syringes-westcoast.com
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#SMiPFSUSA
Hyatt Regency Mission Bay, San Diego, CA, USA
SMi Group Proudly Present the 5th annual...
CONFERENCE:
15TH - 16TH
WORKSHOPS: 17TH
JUNE
2020Assessing Device Development and Regulation for Advanced Innovation
Pre-Filled Syringes
West Coast
PLUS TWO INTERACTIVE POST CONFERENCE WORKSHOPS
WEDNESDAY 17TH JUNE 2020, HYATT REGENCY MISSION BAY, SAN DIEGO, CA, USA
A: Connected Devices and Digital Health: How to Navigate the U.S.
FDA usability Engineering Requirements
Workshop Leader: Shannon Clark¸ Principal, UserWise, Inc.
08.30 - 12.30
B: Postmarket Safety Reporting: The Current Regulatory Environment
with a Global Impact
Workshop Leader: Khaudeja Bano, Sr. Medical Director, Abbott Molecular
13.00 - 17.00
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SPONSORED BY
2. 8.00 Registration & Coffee
9.00 Chairs’ Opening Remarks
Natalie Abts, Head of Human Factors Engineering,
Genentech
Tina Rees, Associate Director – Human Factors,
Ferring Pharmaceuticals
INNOVATIONS IN DEVICE DESIGN AND TECHNOLOGY
OPENING ADDRESS
9.10 Designing a Smart Pre-Filled Syringe Platform to Create
Value for Patients and Industry
• Establishing an internal market research plan to understand
the value of Smart Devices for your organization
• Structuring and executing an external market research
program to understand value to users
• Following a defined process for selecting platform features
• What to consider when creating a platform to serve
multiple different digital strategies for the business
Jace Blackburn, Smart Device Engineer, Genentech
9.50 Leveraging Platforms for Combination Product Development
• Devices suitable for platform approach
• Design control documentation efficiencies
• Clinical and Human Factors considerations and case
studies
Tracy Hsu, Associate Director, Ionis Pharma
10.30 Morning Coffee - Sponsored by
11.00 Spotlight: PATH’s Initiatives in Developing Next
Generation Injectables – The Journey from
Needle Free to Micro-Array Patches
• PATH’s overview of work on injectable device and vaccine
innovations, and Center of Excellence for Microarray Patch
(microneedle) technology
• Value proposition and cost modelling of alternatives to
traditional PFS
• Clinical data to demonstrate efficacy of novel vaccine
delivery devices
• Engineering challenges and opportunities ahead
Darin Zehrung, Global Program Leader, Medical Devices
and Health Technologies, PATH
PANEL DISCUSSION
11.40 Platform approaches for combination products
and pre-filled syringes
• When is it appropriate to develop a platform for a device?
• Design and development considerations
• Preparing the technical development of the platform
• Selecting a design and development partner for platform
devices
Panel Moderator: Jace Blackburn, Smart Device Engineer,
Genentech
Panel Members: James P. Wabby, Executive Director,
Regulatory Affairs – Device/Combination Products, Allergan
Tracy Hsu, Associate Director, Ionis Pharma
Mark DeStefano, Assoc. Dir. CPD – Feasibility, New
Technology and Prototyping Development, Teva
James P. Wabby, Executive Director, Regulatory Affairs –
Device/Combination Products, Allergan
ADVANCES IN HUMAN FACTORS ENGINEERING
12.20 Using Comparative Analysis to Streamline Human Factors
Activities
• Description of comparative analysis method
• Regulatory guidance on comparative analysis
• When and how to apply the method
• Case examples
Natalie Abts, Head of Human Factors Engineering,
Genentech
13.00 Networking Lunch
14.00 Leveraging the patient journey to optimize device use in
home care environment
Severine Duband, Global Category Manager, Nemera
14.40 Human factors – best practices
• Human factors regulatory requirements
• Timing of Human Factors studies during development
• Attributes for good pre-filled syringe design considering
common syringe tasks
• Key considerations for future best practices
Tina Rees, Associate Director – Human Factors,
Ferring Pharmaceuticals
15.20 Afternoon Tea - Sponsored by
15.50 Design Characterization and Verification Best Practices to
Maximize Patient Centered Design
• Test device in design phase on specific technical
characteristics
• Create model from characterization testing to ensure full
understanding of design element(s)
• Redesign (if necessary) to ensure patient’s interest is being
met
• Verify design elements to increase confidence that design
is patient friendly
Brittney Pachucki, Device Engineer, AstraZeneca
16.30 Usability considerations for large-volume injectors
• Target users vs right technology
• How easy can you make it, simpler is better but users need
to know what is happening
• Familiarity, leveraging what user already know or have
seen
• Dosing frequency considerations vs technology complexity
What does the user remember
Mark DeStefano, Assoc. Dir. CPD – Feasibility, New
Technology and Prototyping Development, Teva
17.10 Chairs’ Closing Remarks and Close of Day One
18.00 End of Day One Networking Dinner - Invitation Only
Register online at www.prefilled-syringes-westcoast.com
Pre-Filled Syringes West Coast Conference
DAY ONE | MONDAY 15TH JUNE 2020 www.prefilled-syringes-westcoast.com
Hear from pharma and regulatory KOLs
leading the way in Pre-Filled Syringes
Engage in case studies, regulatory outlooks
and panel discussions exploring the industry
We keep networking at the forefront when it
comes to our attendees. Expand your
community, benefit from the right people and
secure future collaborations
3. 8.30 Registration & Coffee
9.00 Chairs’ Opening Remarks
Natalie Abts, Head of Human Factors Engineering,
Genentech
Tina Rees, Associate Director – Human Factors,
Ferring Pharmaceuticals
COMBINATION PRODUCT REGULATORY INSIGHTS
OPENING ADDRESS
9.10 Regulatory considerations for combination products
• Overview of combination products
• Update on current FDA guidance for combination
products
• Review considerations for combination products
• Recommendations for engagement with the Agency
Sarah Mollo, Combination Product Policy Analyst, Food and
Drug Administration
9.50 Post-Market safety reporting (PMSR) for combination products
- FDA perspective and the global impact
• FDA has pushed out their post-market reporting for the
second year in a row – how has it changed and what does
industry need to be aware of?
• How does FDA review and regulate combination
products?
• How can industry adapt to the global divergence of
reporting in the marketplace?
• Considerations for PMSR compliance and drug/device
application
• We are now close to implementation – what are some of
the immediate things you can do as a preparation check?
Khaudeja Bano, Sr. Medical Director, Abbott Molecular
10.30 Morning Coffee - Sponsored by
11.00 FDA training decay research initiative – an update
• An overview of the pilot study
• A review and assessment of the findings
• How the findings can be applied in practice
Shannon Clark, Principal, Userwise
PROCESS DEVELOPMENT CHALLENGES AND CONSIDERATIONS
11.40 Technical Overview of COP for Prefilled Syringes
• Key properties of COP
• Case Study (New):
- Protein Adsorption of Abatacept – COP vs Glass
- Immunogenicity test of the aggregates
• Case Study: Protein Adsorption of Humira, Embrel,
Remicade – COP vs Glass
• Case Study: Protein Adsorption with/without Polysorbate
(Surfactant) – COP vs Glass
• Leachable data on COP syringes
Larry Atupem, Sr. Business Development Specialist,
Zeon Specialty Materials
12.20 Networking Lunch
13.20 Qualifying the Vial Capping Process: Residual Seal Force and
Container Closure Integrity
• How RSF relates to CCI and how to apply RSF
measurements in a manufacturing environment
• A method capable of differentiating these two sealing
surfaces, which allows the relationship between RSF and
CCI for a single configuration to be established
• A statistical approach for setting a lower RSF limit as an
acceptable criterion
Robert Ovadia, Engineer II, Genentech
14.00 Latest data on OXYCAPT Multilayer Plastic Vial & Syringe
• New Extractables Study
• Oxygen and Ultraviolet Barrier
• Container Closure Integrity by Dye and Helium
• Staked Needle Syringe
Takuya Minezaki, Research Manager,
Mitsubishi Gas Chemical Company, Inc.
14.40 Evaluation of Extractables and Leachables in
Biopharmaceutical Development: General Strategy and
Case Studies
• Performing a holistic E&L assessment to understand your
primary container and single use systems
• How can your E&L study integrate with your toxicity and
immunogenicity study?
• Gaining an understanding of your final drug products
• E&L evaluation to ensure drug-device safety and quality
Jian Liu, Senior Scientist, Amgen
15.20 Afternoon Tea - Sponsored by
DESIGN CONTROLS AND RISK MANAGEMENT
15.50 How Safe Are My Devices? Regulatory Compliance Lifecycle
Management of Combination Products
• Understanding User Needs and Usability
• Quality System Requirements
• Design Control and Product Development Management
• Case Studies on Clinical Trials and Complaint Management
James P. Wabby, Executive Director, Regulatory Affairs –
Device/Combination Products, Allergan
16.30 Managing Changes of Today
• Regulatory expectations for design changes
• Developing a robust design change management process
• Managing design changes & design history file
maintenance
Maggie Reiff, Manager, Device Engineering, Pfizer
17.10 Chairs’ Closing Remarks and Close of Day Two
Alternatively fax your registration to +44 (0)870 9090 712 or call +44 (0)870 9090 711
Pre-Filled Syringes West Coast Conference
DAY TWO | TUESDAY 16TH JUNE 2020 www.prefilled-syringes-westcoast.com
Boston, USA
CONFERENCE:
19TH - 20TH
OCT
2020
Wearable Injectors
& Connected
Devices
San Francisco, USA
CONFERENCE:
14TH - 15TH
SEPT
2020
Pre Filled Syringes
San Francisco
SMi’s Upcoming events in the Pre-Filled USA Series:
4. Overview of the workshop:
Shannon has conducted numerous workshops on human factors and usability testing throughout the
world, from Stockholm to Shanghai. This workshop will discuss the U.S. FDA Human Factors Engineering
Process in the context of digital health and connected devices, as well as unique U.S. FDA regulatory
hurdles related to this domain.
The workshop will include case studies related to emergent digital health innovations currently coming
out of Silicon Valley, software apps connected to drug delivery platforms, and new applications for
medical software.
Reasons to Attend:
• Review all applications for connected devices
• Discuss the unique U.S. FDA regulatory requirements related to phone applications and
connected devices
• Discover common software and device development pitfalls related to connected devices and
digital health
• Walk through the unique considerations for your human factors strategy and the details of
usability testing for Apps and connected devices
About the workshop Leader:
Shannon E. Clark is founder and CEO of UserWise, a consultancy that helps medical device
manufacturers and start-ups to design safe and easy-to-use medical devices. The consultants at
UserWise conduct usability testing for a variety of medical devices ranging from surgical robots
to home-use injection platforms. UserWise consultants also perform safety assessments to comply
with U.S. and international regulations related to Human Factors. Before founding UserWise in 2015,
Shannon was a Human Factors Engineer at Intuitive Surgical and Abbott Laboratories. Shannon
graduated from UCLA with a B.S. in Mechanical Engineering and a technical breadth in Technology
Management. Shannon is additionally a Certified Professional Industrial Engineer, holds two patents,
and has written and published three books.
UserWise is a team of Human Factors Engineers dedicated to designing best-in-class medical
products, packaging, and labelling. With experience ranging from home-use injectables and
diagnostics to robotic surgery platforms, our consultants successfully
navigate medical device and combination product regulations via
usability testing, use-related risk analysis, and compliance documentation.
www.userwiseconsulting.com
Connected Devices and Digital Health: How to Navigate the U.S. FDA Usability Engineering Requirements
POST CONFERENCE WORKSHOP A
08.30 - 12.30
www.prefilled-syringes-westcoast.com
Pre-Filled Syringes West Coast Conference
Wednesday 17th June 2020, Hyatt Regency Mission Bay, San Diego, CA, USA
Workshop Leader:
Shannon Clark, Principal,
Userwise
POST CONFERENCE WORKSHOP B
13.00 - 17.00
Postmarket Safety Reporting: The Current Regulatory Environment with a Global Impact
Overview of the workshop:
With FDA’s guidance document Postmarketing Safety Reporting for Combination Products (PMSR)
recently finalized, it is imperative for companies to be aware of relevant requirements and how
this will need to be implemented for combination products in industry. This workshop will allow for
an in-depth assessment of the finalized guidance, introducing key updates and FDA perspectives.
An interactive analysis of two case studies will allow delegates to evaluate challenges in
implementation and discuss solutions and suggestions from a leading industry expert.
Why You Should Attend:
• Understand key updates and new requirements of FDA’s Postmarketing Safety Reporting
guidance for Combination Products
• Engage in regulatory and industry recommendations for effective implementation
• Assess the new guidance through two interactive case studies
• Discuss challenges, potential solutions and the global impact
About the Workshop Leader:
Khaudeja is a Physician with a Masters in Clinical Research, Pharmaceutical engineering
Certification, a Database Administrator and a certified Project Management Professional. She is
an Abbott President’s award winner, avid Toastmaster and Coach. Khaudeja has more than 25
years’ professional experience, including clinical practice. She has held several global medical
positions at Guidant, Abbott, and AbbVie Inc. Her career includes global medical / clinical and
safety leadership roles in devices, diagnostics, pharmaceuticals and combination products. She
currently serves as the chair for the Post Marketing Safety working group for the Combination
Product Coalition (CPC).
Programme
13.00 Registration and Coffee
13.30 Opening Remarks
13.40 Session 1: Introductory session
• What is the latest news on postmarket safety reporting?
• An update on FDA’s recent perspective
• Understanding the finalized FDA guidance
14.20 Session 2: Case Study introduction and preliminary discussion
• Delegates will be presented with two case studies which
will be used to explore concepts from the final guidance
• Case Study 1: an example of a device primary mode of
action combination product
• Case Study 2: an example of a drug/biologic
15.00 Afternoon Tea
15.30 Session 3: An interactive look at the two case studies
• Delegates will be split into two groups, each focusing on
one of the case studies
• The groups will review best approaches for effective
implementation, assess the applicable requirements and
identify challenges and variations of different reports that
need to be filled
• The groups will present and review their findings for both
case studies
16.30 Session 4: Open Q&A
• Delegates will have the chance to discuss and benchmark
concepts and challenges of postmarket safety reporting
and the surrounding global issues
16.50 Closing Remarks
17.00 End of Workshop
Workshop Leader:
Khaudeja Bano, Sr. Medical Director,
Abbott Molecular
Programme
08.30 Registration and Coffee
09.00 Opening Remarks and Introductions
09.10 Session 1: Connected devices and digital Health - Current
and future Applications
• What’s the digital health landscape and latest buzz in
Silicon Valley, California, as well as the rest of the world?
• What innovations are currently tackling issues of
medication adherence, medical product adherence,
clinical decision support, and remote patient monitoring?
• How are innovators solving patient needs via user
centered design of digital health apps?
09.50 Session 2: Overview of Applicable U.S. FDA usability
Engineering Requirements & Regulatory Requirements for
Connected devices and digital Health
• What U.S. FDA Regulations and Guidance do we need to
know about when developing connected devices and
digital health applications?
• What digital health applications are NOT governed by
the U.S. FDA
10.30 Morning Coffee
11.00 Session 3: Review unique usability engineering considerations
related to connected devices
• Case Study: What are some unique human factors and
usability engineering considerations when developing an
app and connected device?
• Case Study: What are some best practices and design
considerations (i.e. heuristics) to take into account when
developing digital health applications and connected
devices?
• Looking Ahead: What can we expect in 2029?
11.40 Session 4: Q&A
12.30 Closing Remarks and end of workshop
5. PROUDLY SPONSORED BY:
SPONSORSHIP AND EXHIBITION OPPORTUNITIES
SMi offer sponsorship, exhibition, advertising and branding packages, uniquely tailored to compliment you 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 conference please call:
Alia Malick, Director, on +44 (0) 20 7827 6168 or email: amalick@smi-online.co.uk
MARKETING OPPORTUNITIES
Want to know how you can get involved? Interested in promoting your services to this market?
Contact Jinna Sidhu, Marketing Manager, +44 (0) 20 7827 6088 or email: hsidhu@smi-online.co.uk
Pre-Filled Syringes West Coast Conference
www.prefilled-syringes-westcoast.com
Register online at www.prefilled-syringes-westcoast.com
Almac is an established contract development and manufacturing organization that provides an extensive range of integrated services to the pharmaceutical
and biotech sectors globally. From our Audubon, PA facilities, Almac provides innovative commercial packaging solutions built upon quality & flexibility to support
all your packing needs, from niche/orphan drug launches to high volume products. Our specialized packaging solutions for all biopharmaceutical dosage forms
(vials, ampoules, pre-filled syringes, auto-injector pens) includes:
• Pack design and prototype generation • Temperature sensitive storage • Complex kit assembly
• Labeling, assembly and secondary packaging • Serialization
Our wide range of services and flexibility to handle projects of any size, makes us your preferred US packaging partner. www.almacgroup.com
Credence MedSystems is an innovator in injectable drug delivery devices. Credence’s philosophy of Innovation Without Change results in products that impress
and protect end-users while preserving pharma’s existing processes, sourcing strategies and preferred primary package components. The Companion® family
of syringe systems includes proprietary needle-retraction technology, reuse prevention and other critical safety and usability features in Staked and Luer needle
formats. The Dual Chamber platform offers single-step mixing and injection for drugs requiring reconstitution at the time of delivery. Additional products such as
metered dose devices, multi-length staked needles and other novel devices address the needs of specific therapeutic markets. www.credencemed.com
Mitsubishi Gas Chemical is a leading company in the field of oxygen barrier and absorbing technologies. Based on these technologies and experiences, we have
successfully developed multilayer plastic vial and syringe having excellent oxygen, ultra violet and water vapor barrier. The products make it possible to replace
glass with plastic for injectable drugs. https://www.mgc.co.jp/eng/products/abd/oxycapt.html
Nemera is a world leader in the design, development and manufacturing of drug delivery devices for the pharmaceutical, biotechnology & generics industries.
Nemera always puts patients first, providing services and products for several key delivery routes: Parenteral, Ophthalmic, Nasal, Buccal, Auricular, Inhalation,
Dermal/Transdermal. Nemera leverages decades of experience in the parenteral device segment from full development to pure contract manufacturing,
through customized solutions. Nemera developed: - Safe’n’Sound®, a fully passive safety device for prefilled syringes to avoid accidental needle-sticks. - Safelia®,
a new generation of 2-steps auto-injector for fluid and viscous formulations. www.nemera.net
Owen Mumford Pharmaceutical Services is a specialist in the design, development and manufacture of injectable drug delivery systems for the pharmaceutical,
biotech & generics industries. These include single dose and multidose reusable and disposable auto-injectors, pens and syringes for subcutaneous and
intramuscular administration. Our innovative products are designed to meet both the need of our pharmaceutical partners and their patients by facilitating ease
of use and improving safety and patient compliance. Our devices are also designed with aim of reducing complexity and risk for the pharmaceutical & biotech
industry in the development of their combination products. www.ompharmaservices.com
PHC Corporation of North America is a subsidiary of PHC Holdings Corporation, Tokyo, Japan, a global leader in Medical Devices, Healthcare IT and Life Sciences.
With drug delivery devices, ultra-low temperature freezers, biomedical refrigerators and incubators, PHC offers technologies and solutions for pharmaceutical, life
science and biotechnology applications across industries. www.phchd.com/global/
Steri-Tek is a high-volume E-beam/X-Ray contract sterilizer and R&D innovation center serving the medical device, biotech, pharmaceutical and other industries.
Steri-Tek is a ISO 11137 and ISO 13485 certified, FDA registered, DEA registered as well as State of California Medical Device and Drug Manufacturing licensed
facility. Particularly with sensitive materials and complex devices, Steri-Tek has developed a proprietary system for optimizing E-beam/X-Ray sterilization of drugs/
biologics in combination devices, pre-filled syringes, implantables, bioabsorbables and other complex products. www.steri-tek.com
ZEON’s Zeonex® and Zeonor® cyclo olefin polymer (COP) allow for advanced, break-resistant syringes, vials and lyophilization containers for protein-based
biopharmaceuticals, high viscosity drugs, and contrast media. They also offer high purity, “glass-like” transparency, sterilization, low water absorption, and superior
moldability, as well as overcome protein adsorption and ph shift concerns. www.zeonex.com
SUPPORTED BYOFFICIAL
MEDIA PARTNERS
KEY MEDIA PARTNERS
110+
Industry
professionals
7+
Dedicated hours
of networking
Attendee Geography:
USA 77%
Europe 10%
United
Kingdom 7%
Asia
Pacific 6%
Breakdown by Job Function
C-level 9%
Vice President 3%
Director 17%
Product Manager 15%
Senior Device Manager 6%
Senior Principal Scientist 11%
Supply Chain Manager 1%
Quality Assurance 4%
Packaging Expert 3%
Regulatory Affairs 2%
Business Development Manager 16%
Senior Engineer 13%
Pre-Filled Syringes
West Coast
Past Attendee
Breakdown
6. PRE-FILLED SYRINGES WEST COAST 2020
Conference: Monday 15th & Tuesday 16th June 2020, Hyatt Regency Mission Bay, San Diego, CA, USA
Workshops: Wednesday 17th June 2020, Hyatt Regency Mission Bay, San Diego, CA, USA
4 WAYS TO REGISTER
www.prefilled-syringes-westcoast.com
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,
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If you have any further queries please call the Events Team on tel +44 (0) 870 9090 711 or you can email them at events@smi-online.co.uk
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address provided during registration. Details are sent within 24 hours post conference.