Hear from a selection of carefully handpicked keynote addresses and case studies presented by big pharma such as Genentech, Allergan, Medimmune and Roche as well leading industry KOL's including Nemera, Nipro PharmaPackaging, Terumo, Worrell, Zeon + more!
SMi Group are thrilled to announce the return of Pre-Filled Syringes West Coast 2017 which arrives to California on June 5th & 6th.
Following on from sell-out shows in Europe and Boston, Pre-Filled Syringes West Coast will once again gather a global audience of medical device experts and PFS industry leaders to discuss new developments and showcase cutting edge advances, keeping you at the forefront of a booming industry.
The competitive PFS market has sparked great improvements as devices strive for higher quality, safety, and patient satisfaction. Innovation and excellence is requested at every level making Pre-Filled Syringes West Coast the perfect platform to strengthen knowledge in key principles such as human factor engineering, manufacturing and complex biologics, whilst honing in on emerging trends for parenteral devices, including auto injectors, pens, pumps and smart devices.
5th Annual Pre-Filled Syringes East CoastTeri Arri
Building on the success of previous sell-out shows, SMi Group is delighted to announce the return of the 5th annual conference and exhibition: Pre-Filled Syringes - East Coast, taking place on April 11th – 12th 2018 in Boston, Massachusetts, USA.
A rise in chronic diseases, improvements in technology and a growing demand for easy to use drug administration products has in recent years, created a booming Pre-Filled Syringes industry.
Some notable areas of increased attention have been the broader trends for combination products and biologics, as well as the move towards digital health and improving patient adherence due to increased self-administration figures. As well as these areas of lucrative opportunity, there are still several ongoing challenges that the key-thought leaders are battling to overcome such as chemical compatibility, user safety, high-volume and highly viscous formulation, and non-compliance.
Pre-Filled Syringes East Coast will once again play host to an international audience of drug delivery, medical device and PFS experts to discuss emerging trends and offer innovative solutions to the challenges facing the prefilled industry, helping attendees to secure global success for their PFS device.
SMi Group are thrilled to announce the return of Pre-Filled Syringes West Coast 2017 which arrives to California on June 5th & 6th.
Following on from sell-out shows in Europe and Boston, Pre-Filled Syringes West Coast will once again gather a global audience of medical device experts and PFS industry leaders to discuss new developments and showcase cutting edge advances, keeping you at the forefront of a booming industry.
The competitive PFS market has sparked great improvements as devices strive for higher quality, safety, and patient satisfaction. Innovation and excellence is requested at every level making Pre-Filled Syringes West Coast the perfect platform to strengthen knowledge in key principles such as human factor engineering, manufacturing and complex biologics, whilst honing in on emerging trends for parenteral devices, including auto injectors, pens, pumps and smart devices.
5th Annual Pre-Filled Syringes East CoastTeri Arri
Building on the success of previous sell-out shows, SMi Group is delighted to announce the return of the 5th annual conference and exhibition: Pre-Filled Syringes - East Coast, taking place on April 11th – 12th 2018 in Boston, Massachusetts, USA.
A rise in chronic diseases, improvements in technology and a growing demand for easy to use drug administration products has in recent years, created a booming Pre-Filled Syringes industry.
Some notable areas of increased attention have been the broader trends for combination products and biologics, as well as the move towards digital health and improving patient adherence due to increased self-administration figures. As well as these areas of lucrative opportunity, there are still several ongoing challenges that the key-thought leaders are battling to overcome such as chemical compatibility, user safety, high-volume and highly viscous formulation, and non-compliance.
Pre-Filled Syringes East Coast will once again play host to an international audience of drug delivery, medical device and PFS experts to discuss emerging trends and offer innovative solutions to the challenges facing the prefilled industry, helping attendees to secure global success for their PFS device.
SMi proudly presents due to the huge success of our Pharmaceutical Microbiology UK event the launch of SMi's Pharmaceutical Microbiology USA Conference in San Diego on 8th and 9th June 2017. Latest reports show that global rapid microbiology tests market to reach a net worth USD 19.5 Bn by 2022.* With the field growing at such a rapid rate SMi would like to take this opportunity to invite you to join us as we address the hot topics of the industry such as RMM, low endotoxin recovery, risk assessment and many more! With the forthcoming changes to annexe 1, take this opportunity to hear direct regulatory feedback and benchmark your strategies amongst industry peers. Our 2 day event will include presentations from both regulatory and industry experts sharing recent case studies and developing trends in the field of pharmaceutical microbiology
P 141 pre-filled syringes america revisedAlia Malick
The global prefilled syringe market is estimated to reach $6.9bn by 2018. This figure is reflective of manufacturers striving to improve their technologies to meet the increasing number of biologic drugs reaching the market. The rising demand for prefilled syringes is driving the manufacturers to introduce improvements in technology and with the focus still on the safety for the user, innovation improvements for device development and ease of use for the patient are key areas to be addressed.
SMi’s leading prefilled syringes conference will focus on a number of hot talking points that will no doubt cause controversy and debate and on reflection open the floor to discussion in our breakout sessions. In addition, with a new competitive market just around the corner for biosimilars we look at this new session for 2015 in addition to the vision and benefit of lyophilisation in a prefilled syringe.
World ADC Frankfurt 2015 - sample brochureWorld ADC
The World ADC Frankfurt meeting has been established with the simple mission of speeding up the development of more potent and safe antibody drug conjugates.
Learn not only how to make an ADC, but how to make a great one. With insights on numerous novel payload technologies, robust strategies for preclinical evaluation and emerging clinical data, there is no better opportunity to accelerate your research.
Program - American Chemical Manufacturing Summit 2013, PittsburghMark Blendheim
The American Chemical Manufacturing Summit brings together industry leaders to discuss the current state of the industry and the impact of new regulations. The summit provides chemical manufacturing, quality and supply chain executives valuable insight into new manufacturing strategies, technology and Operational Excellence.
“A key source of growth in biologics over the next several years will be Biomanufacturing” Ge Li, Chairman and CEO, Wuxi” <outsourcing-pharma.com,>
“Other issues with single-use include standardization of systems, the dependability to vendors, and the supply chain and waste management but if we can overcome extractables and leachables, we will eventually be able to scale up to many thousands of liters.” Jason Li, Senior Director, Downstream Processing, Genor Biopharma <biopharma-reporter.com,>
Industry experts will discuss these and more at the 5th Annual Biomanufacturing Conference in Grand Hyatt Shanghai, China on 19 – 22 May 2015 during IBC’s Biopharma Development & Production (BDP) Week.
Highly Potent Active Pharmaceutical Ingredients 2017Fateja Begum
The Highly Potent Active Pharmaceutical Ingredients conference features key speakers of the industry presenting challenges, issues, innovation and new developments in various areas of HPAPI production, development and manufacturing.
A recent survey commissioned by Synopsys was designed to understand the risks to clinicians and patients due to insecure medical devices. The resulting report identified some expected findings, but others were extremely surprising. For instance, 67% of medical device manufacturers and 56% of healthcare delivery organizations believe an attack on a medical device built or in use by their organization is likely to occur over the next 12 months. Join Larry Ponemon of the Ponemon Institute and Mike Ahmadi of Synopsys as they discuss report highlights. They provide insight and predictions regarding the future of security in the medical device and healthcare industries.
This International Women's Day, INSEAD takes a look at persistent myths about women in business that need to be shattered and replaced with clear facts. Because when women have the same opportunities to rise up the ranks and take the lead, organisations do better.
#IWD2017 #BeBoldForChange
Learn more about the INSEAD's degree programmes:
MBA - http://inse.ad/NoJOuh
Global Executive MBA - http://inse.ad/sCUvQU
Executive Master in Finance - http://inse.ad/YIp7yF
SMi proudly presents due to the huge success of our Pharmaceutical Microbiology UK event the launch of SMi's Pharmaceutical Microbiology USA Conference in San Diego on 8th and 9th June 2017. Latest reports show that global rapid microbiology tests market to reach a net worth USD 19.5 Bn by 2022.* With the field growing at such a rapid rate SMi would like to take this opportunity to invite you to join us as we address the hot topics of the industry such as RMM, low endotoxin recovery, risk assessment and many more! With the forthcoming changes to annexe 1, take this opportunity to hear direct regulatory feedback and benchmark your strategies amongst industry peers. Our 2 day event will include presentations from both regulatory and industry experts sharing recent case studies and developing trends in the field of pharmaceutical microbiology
P 141 pre-filled syringes america revisedAlia Malick
The global prefilled syringe market is estimated to reach $6.9bn by 2018. This figure is reflective of manufacturers striving to improve their technologies to meet the increasing number of biologic drugs reaching the market. The rising demand for prefilled syringes is driving the manufacturers to introduce improvements in technology and with the focus still on the safety for the user, innovation improvements for device development and ease of use for the patient are key areas to be addressed.
SMi’s leading prefilled syringes conference will focus on a number of hot talking points that will no doubt cause controversy and debate and on reflection open the floor to discussion in our breakout sessions. In addition, with a new competitive market just around the corner for biosimilars we look at this new session for 2015 in addition to the vision and benefit of lyophilisation in a prefilled syringe.
World ADC Frankfurt 2015 - sample brochureWorld ADC
The World ADC Frankfurt meeting has been established with the simple mission of speeding up the development of more potent and safe antibody drug conjugates.
Learn not only how to make an ADC, but how to make a great one. With insights on numerous novel payload technologies, robust strategies for preclinical evaluation and emerging clinical data, there is no better opportunity to accelerate your research.
Program - American Chemical Manufacturing Summit 2013, PittsburghMark Blendheim
The American Chemical Manufacturing Summit brings together industry leaders to discuss the current state of the industry and the impact of new regulations. The summit provides chemical manufacturing, quality and supply chain executives valuable insight into new manufacturing strategies, technology and Operational Excellence.
“A key source of growth in biologics over the next several years will be Biomanufacturing” Ge Li, Chairman and CEO, Wuxi” <outsourcing-pharma.com,>
“Other issues with single-use include standardization of systems, the dependability to vendors, and the supply chain and waste management but if we can overcome extractables and leachables, we will eventually be able to scale up to many thousands of liters.” Jason Li, Senior Director, Downstream Processing, Genor Biopharma <biopharma-reporter.com,>
Industry experts will discuss these and more at the 5th Annual Biomanufacturing Conference in Grand Hyatt Shanghai, China on 19 – 22 May 2015 during IBC’s Biopharma Development & Production (BDP) Week.
Highly Potent Active Pharmaceutical Ingredients 2017Fateja Begum
The Highly Potent Active Pharmaceutical Ingredients conference features key speakers of the industry presenting challenges, issues, innovation and new developments in various areas of HPAPI production, development and manufacturing.
A recent survey commissioned by Synopsys was designed to understand the risks to clinicians and patients due to insecure medical devices. The resulting report identified some expected findings, but others were extremely surprising. For instance, 67% of medical device manufacturers and 56% of healthcare delivery organizations believe an attack on a medical device built or in use by their organization is likely to occur over the next 12 months. Join Larry Ponemon of the Ponemon Institute and Mike Ahmadi of Synopsys as they discuss report highlights. They provide insight and predictions regarding the future of security in the medical device and healthcare industries.
This International Women's Day, INSEAD takes a look at persistent myths about women in business that need to be shattered and replaced with clear facts. Because when women have the same opportunities to rise up the ranks and take the lead, organisations do better.
#IWD2017 #BeBoldForChange
Learn more about the INSEAD's degree programmes:
MBA - http://inse.ad/NoJOuh
Global Executive MBA - http://inse.ad/sCUvQU
Executive Master in Finance - http://inse.ad/YIp7yF
GICSA es la empresa líder en el desarrollo, inversión, comercialización y operación de centros comerciales, oficinas corporativas y naves industriales.
Getting more customers is the first thing that comes to mind when someone says making more money for a business. So, to increase your customer retention rates, I've compiled a list of top 7 efficient techniques for retaining customers.
GICSA es la empresa líder en el desarrollo, inversión, comercialización y operación de centros comerciales, oficinas corporativas y naves industriales.
Podczas zorganizowanych (na początku 2014 r.) w pięciu placówkach dla dzieci i młodzieży Biblioteki Publicznej w Dzielnicy Targówek warsztatów w formie zabawy, powstało 14 bajek z ilustracjami, których autorami są uczniowie szkół podstawowych na warszawskim Targówku, a ich redaktorem pisarz – Marek Samselski.
GICSA es la empresa líder en el desarrollo, inversión, comercialización y operación de centros comerciales, oficinas corporativas y naves industriales.
See the best parts of Montenegro on this mini tour! We take you to visit three places with a great history - three places with a soul. This is tour where you will learn about the old customs in Montenegro, and also those who maintain till today. See the incredible landscapes and old buildings that will not leave you indifferent.
Every Montenegrin will say: "Who didn't saw Cetinje, haven't been in Montenegro!" So don't miss to visit the most significant city in the history and culture of Montenegro and it's numerous monuments: The Cetinje monastery, from which Montenegrin bishops ruled through the centuries; Palace of King Nikola, Montenegrin king who together with his daughters made connection with 4 European courts; Vladin Dom, art museum with huge collection of art paintings and historical symbols, numerous embassies and museums... After meeting your guide at the pier, you walk to your awaiting vehicle which will take you to Njegusi, a quiet mountain village.
Pharmaceutical Quality - The Office ofAjaz Hussain
The keynote address at the Fall meeting of the CPPR Industrial Advisory Board and the Site Directors held yesterday (27 October 2014) at Purdue University. The talk provides a perspective on the recent organizational changes announced by FDA CDER - the Office of Pharmaceutical Quality.
Join us in learning the newest trends and technical advances in the use of Polymeric Materials in Medical Applications; speakers are from premier institutions such as the world-class Ronald Reagan Medical Center at UCLA, ABBOTT Vascular, JOHNSON & JOHNSON-Cordis, BOSTON SCIENTIFIC, MEDTRONIC, REVA Medical, MiMEDX, BECKTON DICKINSON, ROCHE Diagnostics and more.
For Registration / Sponsorship / Details, please CLICK the link below:
http://www.MediPlastConference.com
Precision Medicine & Biomarkers Leaders Summit - Boston USA - 7th & 8th MayTony Couch
Tracks focus on R&D strategies, Biomarker development, Immuno-oncology, CDx development, AI and Big data analysis and approaches – Attending this Summit will provide you with the opportunity to mix and interact with experts working in all facets of Precision Medicine through the individual, panel and roundtable discussions on offer.
Why you should attend:
1. Learn from in-depth case studies on strategic partnering and effective collaboration
2. Explore new business opportunities and strategies to reach the biosimilars market in the region
3. Gain insights into the regulatory landscape for biosimilars in China, India, Korea, Taiwan and more
4. Gather the latest market intelligence and analysis and identify new trends and opportunities in Biosimilars R&D, contract manufacturing and commercialization in Asia
报名参加的五大理由
1. 深入学习有关与亚洲公司建立战略合作和有效协作的案例研究
2. 探索新的商机和战略,以便进入当地的生物仿制药市场
3. 深入了解中国、印度、韩国、台湾以及更多国家或地区的生物仿制药监管形势
4. 收集最新的市场情报和分析,确定生物仿制药研发、合同制造和商业化在亚洲的新趋势和机会
Hear about:
Biopharma Regulatory Updates and Development
Victoria Elegant, VP Medical & Regulatory Affairs, Baxter, China
Andrea Laslop, Head of Scientific Office, Austrian Agency for Food and Health Safety, Austrian Member, European Medicines Agency
Arvind Mishra, Global Head of Quality & Regulatory & Head of Strategic Business Unit, Biologicals, Cadilla Pharmaceutical, India
Advances in Biosimilars R&D
Jeffrey Su, CSO, Cytovance Biologics, USA
Wenzhi Tian, CEO, Huabo Biopharma, China
Ming Wang, President and COO, Gan & Lee Pharmaceuticals, China
Feng Li, CEO, Beijing Mabworks, China
Shaligram Rane, Vice President for Quality, Intas Pharmaceuticals, India
Understanding Obstacles and Hurdles for Entering the Biosimilars Market
Khai Meng Ang, Vice President Asia, Hospira, China
Jason Li, Senior Director, Genor Biopharma, China
Sachidananda Moorthy, Vice President - Clinical Research, Medical and Regulatory Affairs, Avesthagen, India
Sameer Agarwal, Senior Vice President, Business Center Strategic Marketing, Business Unit Generic Drugs & Standard Solutions, Fresenius Kabi, Germany
What can Asia Learn from Global Biosimilars Development and Litigation?
Li Cai, Regional R&D Counsel, Pfizer, China
Vivek Mittal, Head – Legal, Lupin, India
Viren Mahurkar, Managing Director, HitechnRock Advisors, Singapore
http://www.biosimilarsasia.com
Pre-Conference Special Focus Day, 20 May 2014
Clinical Development for Biosimilars
Post-Conference Workshops, 23 May 2014
A: Challenges in Demonstrating Biosimilarity and Interchangeability of Biosimilar Products
B: Successfully Bringing Biosimilars to Market
会前特别关注日,2014 年 5 月 20 日
生物仿制药的临床开发
会后研讨会,2014 年 5 月 23 日
A:在展示生物仿制药产品的生物相似性和可互换性方面所面临的挑战
B:成功地将生物仿制药推向市场
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Factory Supply Best Quality Pmk Oil CAS 28578–16–7 PMK Powder in Stockrebeccabio
Factory Supply Best Quality Pmk Oil CAS 28578–16–7 PMK Powder in Stock
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Hot Selling Organic intermediates
ARTIFICIAL INTELLIGENCE IN HEALTHCARE.pdfAnujkumaranit
Artificial intelligence (AI) refers to the simulation of human intelligence processes by machines, especially computer systems. It encompasses tasks such as learning, reasoning, problem-solving, perception, and language understanding. AI technologies are revolutionizing various fields, from healthcare to finance, by enabling machines to perform tasks that typically require human intelligence.
Title: Sense of Smell
Presenter: Dr. Faiza, Assistant Professor of Physiology
Qualifications:
MBBS (Best Graduate, AIMC Lahore)
FCPS Physiology
ICMT, CHPE, DHPE (STMU)
MPH (GC University, Faisalabad)
MBA (Virtual University of Pakistan)
Learning Objectives:
Describe the primary categories of smells and the concept of odor blindness.
Explain the structure and location of the olfactory membrane and mucosa, including the types and roles of cells involved in olfaction.
Describe the pathway and mechanisms of olfactory signal transmission from the olfactory receptors to the brain.
Illustrate the biochemical cascade triggered by odorant binding to olfactory receptors, including the role of G-proteins and second messengers in generating an action potential.
Identify different types of olfactory disorders such as anosmia, hyposmia, hyperosmia, and dysosmia, including their potential causes.
Key Topics:
Olfactory Genes:
3% of the human genome accounts for olfactory genes.
400 genes for odorant receptors.
Olfactory Membrane:
Located in the superior part of the nasal cavity.
Medially: Folds downward along the superior septum.
Laterally: Folds over the superior turbinate and upper surface of the middle turbinate.
Total surface area: 5-10 square centimeters.
Olfactory Mucosa:
Olfactory Cells: Bipolar nerve cells derived from the CNS (100 million), with 4-25 olfactory cilia per cell.
Sustentacular Cells: Produce mucus and maintain ionic and molecular environment.
Basal Cells: Replace worn-out olfactory cells with an average lifespan of 1-2 months.
Bowman’s Gland: Secretes mucus.
Stimulation of Olfactory Cells:
Odorant dissolves in mucus and attaches to receptors on olfactory cilia.
Involves a cascade effect through G-proteins and second messengers, leading to depolarization and action potential generation in the olfactory nerve.
Quality of a Good Odorant:
Small (3-20 Carbon atoms), volatile, water-soluble, and lipid-soluble.
Facilitated by odorant-binding proteins in mucus.
Membrane Potential and Action Potential:
Resting membrane potential: -55mV.
Action potential frequency in the olfactory nerve increases with odorant strength.
Adaptation Towards the Sense of Smell:
Rapid adaptation within the first second, with further slow adaptation.
Psychological adaptation greater than receptor adaptation, involving feedback inhibition from the central nervous system.
Primary Sensations of Smell:
Camphoraceous, Musky, Floral, Pepperminty, Ethereal, Pungent, Putrid.
Odor Detection Threshold:
Examples: Hydrogen sulfide (0.0005 ppm), Methyl-mercaptan (0.002 ppm).
Some toxic substances are odorless at lethal concentrations.
Characteristics of Smell:
Odor blindness for single substances due to lack of appropriate receptor protein.
Behavioral and emotional influences of smell.
Transmission of Olfactory Signals:
From olfactory cells to glomeruli in the olfactory bulb, involving lateral inhibition.
Primitive, less old, and new olfactory systems with different path
New Directions in Targeted Therapeutic Approaches for Older Adults With Mantl...i3 Health
i3 Health is pleased to make the speaker slides from this activity available for use as a non-accredited self-study or teaching resource.
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STATEMENT OF NEED
Mantle cell lymphoma (MCL) is a rare, aggressive B-cell non-Hodgkin lymphoma (NHL) accounting for 5% to 7% of all lymphomas. Its prognosis ranges from indolent disease that does not require treatment for years to very aggressive disease, which is associated with poor survival (Silkenstedt et al, 2021). Typically, MCL is diagnosed at advanced stage and in older patients who cannot tolerate intensive therapy (NCCN, 2022). Although recent advances have slightly increased remission rates, recurrence and relapse remain very common, leading to a median overall survival between 3 and 6 years (LLS, 2021). Though there are several effective options, progress is still needed towards establishing an accepted frontline approach for MCL (Castellino et al, 2022). Treatment selection and management of MCL are complicated by the heterogeneity of prognosis, advanced age and comorbidities of patients, and lack of an established standard approach for treatment, making it vital that clinicians be familiar with the latest research and advances in this area. In this activity chaired by Michael Wang, MD, Professor in the Department of Lymphoma & Myeloma at MD Anderson Cancer Center, expert faculty will discuss prognostic factors informing treatment, the promising results of recent trials in new therapeutic approaches, and the implications of treatment resistance in therapeutic selection for MCL.
Target Audience
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Learning Objectives
1.) Identify clinical and biological prognostic factors that can guide treatment decision making for older adults with MCL
2.) Evaluate emerging data on targeted therapeutic approaches for treatment-naive and relapsed/refractory MCL and their applicability to older adults
3.) Assess mechanisms of resistance to targeted therapies for MCL and their implications for treatment selection
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Pre-Filled Syringes West Coast 2017
1. Successful Incorporation of Human Factors in Prefilled Devices
08.30 - 12.30
Workshop Leader:
Melanie Turieo, Director, Global MedTech Division, Cambridge Consultants
PLUS ONE INTERACTIVE HALF-DAY POST-CONFERENCE WORKSHOP
Wednesday 7th June, Hyatt Regency, Mission Bay, San Diego, CA, USA
REGISTER BY 28TH FEBRUARY AND SAVE $300
REGISTER BY 31ST MARCH AND SAVE $200
REGISTER BY 28TH APRIL AND SAVE $100
Sponsored by:
Enabling quality excellence through innovation
SMi proudly present their 2nd annual conference and exhibition...
Pre-Filled Syringes
West Coast
5TH - 6TH
JUNE
2017Hyatt Regency, Mission Bay, San Diego, CA, USAHyatt Regency, Mission Bay, San Diego, CA, USA
CHAIR:
• Mike Stelmah, Senior Manager, Combination
Products Regulatory Affairs, Regeneron
KEYNOTE SPEAKERS:
• John Smith, Director, Global Regulatory Affairs, Allergan
• Anand Subramony, Vice President Drug Delivery & Device
Development, MedImmune
• Benir Ruano, VP, Global Manufacturing and Technical
Operations, Xeris Pharmaceuticals
• Ron Forster, Executive Director, Amgen
• Sara McNew, Director, Human Factors and Industrial
Design, Eli Lilly
• Alasdair Young, Device Engineer, Genentech
• Lori de los Reyes, Global Regulatory Affairs, Amgen
• Ariel Waitz, Senior Engineer, Genentech
• Aaron Chesterman, Principal Engineer, Device
Development, Genentech
• Tina Rees, Associate Director – Human Factors, Ferring
• Mayumi Bowen, Senior Engineer, Genentech
• Monica de Bardi, Postdoctoral Researcher, Roche
To attend, contact Fateja Begum on Tel +44 (0) 20 7827 6184,
Fax +44 (0) 20 7827 6185, email fbegum@smi-online.co.uk
or visit www.smi-online.co.uk/ts05.asp to register online @SMIPHARM
#smipfsusa
HIGHLIGHTS IN 2017:
• Explore and harness the global regulatory ecosystem;
global compliance requirements for product safety and
risk analysis
• Assess data bridging and risk based control strategies
for combination products
• Map the importance of Human factors and patient
centricity in device design
• Highlight the emerging trends of connected health and
the future of patient centric drug delivery
• Cutting edge industry insight on silicone free devices,
virtual reality, and laser cutting in the design and
manufacture of prefilled devices
Enabling quality excellence through innovation
CHAIR:
• Mike Stelmah, Senior Manager, Combination
Products Regulatory Affairs, Regeneron
KEYNOTE SPEAKERS:
• John Smith, Director, Global Regulatory Affairs, Allergan
• Anand Subramony, Vice President Drug Delivery & Device
Development, MedImmune
• Benir Ruano, VP, Global Manufacturing and Technical
Operations, Xeris Pharmaceuticals
HIGHLIGHTS IN 2017:
• Explore and harness the global regulatory ecosystem;
global compliance requirements for product safety and
risk analysis
2. Pre-Filled Syringes West Coast
Day One | Monday 5th June 2017 www.smi-online.co.uk/ts05.asp
08.30 Registration & Coffee
09.00 Chairman’s Session Opening Remarks
Mike Stelmah, Senior Manager, Combination Products
Regulatory Affairs, Regeneron
OPENING ADDRESS
09.10 Navigating the global regulatory ecosystem
• Taking into account regulatory requirements for USA,
Europe and ROW to ensure your product’s success on
a global market
• Update on key points from different regulatory bodies
• What to consider when seeking approval; safety
assessments, human factors considerations
John Smith, Director, Global Regulatory Affairs, Allergan
09.50 Navigating technical complaints, product safety and
regulatory requirements
• Taking into account regulatory requirements for product
safety and complaint handling
• Update on key product failures and challenges
• What to consider while planning safety assessments, risk
analysis and complaint handling for clinical studies and
commercial
Mike Stelmah, Senior Manager, Combination Products
Regulatory Affairs, Regeneron
10.30 Morning Coffee and
Networking Break sponsored by
11.00 Large volume subcutaneous infusion devices; in vivo and in
vitro challenges
• Drivers for large volume subcutaneous delivery
• Technical criteria when evaluating devices for large
volume subcutaneous delivery
• Use of large volume subcutaneous devices in clinic,
including potential complicating factors
Ariel Waitz, Senior Engineer, Genentech
Aaron Chesterman, Principal Engineer, Device
Development, Genentech
11.40 PLAJEX with safe ‘n’ sound; safe delivery of biotherapeutics
• Polymer PFS are developed for providing an
appropriate primary drug container, particularly for
biopharmaceuticals
• A platform of add-on passive sharps injury protection
devices for PFS are serving the patients and healthcare
providers for minimizing the risks of needle-stick injuries
• A cooperation to establish and confirm compatibility
between PLAJEX COP prefillable syringes and the
Safe’n’Sound device platform
William Dierick, Director of Technology Development, Terumo
Adrien Tisserand, Global Category Manager – Parenteral &
CMO, Nemera
12.20 Networking Lunch sponsored by Worrell
13.30 Combination product data bridging
• Guidance on clinical bridging, examples of when clinical
bridging may be necessary
• Clinical home use study design
• Examples of FDA feedback on the need for clinical home
use
• Leveraging pre-existing data and human factors
Lori de los Reyes, Director, Global Regulatory Affairs, Amgen
14.10 Combination product, a need for innovative and
customizable drug delivery devices
Adrien Tisserand, Global Category Manager - Parenteral &
CMO, Nemera
14.50 OXYCAPT™ multilayer plastic vial & syringe with glass-like
gas barrier for biologics
• Glass vs. plastic
• Disadvantages of plastic
• How to overcome the disadvantages of plastic
Shota Arakawa, Researcher, Mitsubishi Gas Chemical
15.30 Afternoon Tea and
Networking Break sponsored by
16.00 An approach to developing risk-based control strategies for
combination products
• Defining and establishing critical quality attributes for a
combination product
• Utilizing a risk-based approach to defining a control
system
• A case study on deployment of the control strategy
process for a combination product
Alasdair Young, Device Engineer, Genentech
16.40 Glucagon synthetic peptide formulation in PFS filled
auto-injector combination product platform
• Challenges with a non-aqueous drug formulation
compatibility with PFS components
• Challenges with manufacturing aseptically filled low
fill volume PFS
• Challenges with an international supply chain
Benir Ruano, VP, Global Manufacturing and Technical
Operations, Xeris Pharmaceuticals
17.20 Panel Discussion: Combination products
– challenges and opportunities
• On the road to patient-centric drug delivery -
understanding the patient’s interaction with
the delivery system to be able to incorporate
features which promote adherence to treatments
• Identifying the good manufacturing regulations that
apply to combination products
• Technical challenges for developing and manufacturing
combination products
• Regulatory hurdles in obtaining approval for pre-filled
syringes and pens in human factors studies
Moderated by: John Smith, Director, Global Regulatory
Affairs, Allergan
Anand Subramony, Vice President Drug Delivery & Device
Development, MedImmune
Tina Rees, Associate Director - Human Factors, Ferring
Sara McNew, Director, Human Factors and Industrial Design,
Eli Lilly
18.00 Chairman’s Closing Remarks and Close of Day One
REGULATION & STRATEGY
DESIGN CONSIDERATIONS FOR PFS
To attend, contact Fateja Begum on Tel +44 (0) 20 7827 6184, Fax +44 (0) 20 7827 6185,
email fbegum@smi-online.co.uk or visit www.smi-online.co.uk/ts05.asp to register online
BIOLOGICS – CHALLENGES AND OPPORTUNITIES
Conference Chairman’s Welcome Letter
Dear Participants,
Pre-filled syringe (PFS) role in pharmaceutical industry has become more
critical in the recent years. Syringes are no longer used just as a standalone
product, but are key aspects of autoinjectors and safety systems that provide
improved usability and safety for the patients. With these improvements,
come the technical, regulatory and drug development challenges
associated with using a PFS.
Pre-filled Syringes may seem as simple products, but as each process and
feature of the syringe increases the complexity of the product and needs
significant focus to achieve a successful launch on the market. From glass
cane creation, syringe forming, siliconization, leachable and extractable
studies, to device integration, regulatory filing and functional testing; all
play a vital role to make a functional product approved on the market and
safely used by patients. It is critical to develop working relationships and
collaborations, as an industry, to bring knowledge to the suppliers and drug
developers worldwide, so that we can address these challenges. Thank
you to everyone who contributes to this goal and looking forward to your
participation at the conference.
Sincerely,
Mike Stelmah, MBA, PMP, RAC (US & Global)
Sr. Manager, Combination Products Regulatory Affairs
Regeneron Pharmaceutical, Inc.
Mike Stelmah, MBA, PMP, RAC (US & Global)
3. Pre-Filled Syringes West Coast
www.smi-online.co.uk/ts05.asp Day Two | Tuesday 6th June 2017
GIVING YOUR DEVICE A HUMAN TOUCH
08.30 Registration & Coffee
09.00 Chairman’s Opening Remarks
Mike Stelmah, Senior Manager, Combination Products
Regulatory Affairs, Regeneron
09.10 Creating patient centric combination products
• Patient centricity
• Connected health
• Drug delivery
Anand Subramony, Vice President Drug Delivery & Device
Development, MedImmune
09.50 How Mixed Reality will drive the future of drug delivery
product development
• What does virtual reality mean for ethnography and
human factors testing?
• How can we use augmented reality to impact device
development & sales?
• How can we apply this to the frontlines of healthcare?
Derek Mathers, Director of Advanced Applications
Development, Worrell
Matt Gottschalk, Medical Device Consultant, Worrell
10.30 Morning Coffee and
Networking Break sponsored by
11.00 Giving the device a human touch
• The role of patient centricity in drug delivery and device
development
• Successfully incorporating human factors into device
design
• Human factors regulations and guidelines for successful
approval
Sara McNew, Director, Human Factors and Industrial
Design, Eli Lilly
11.40 Human factors implications of innovative delivery systems
for biologics
• Overview of alternatives to prefilled syringes in parenteral
drug delivery, such as autoinjectors, patches, pumps,
and pens
• Performing formative and summative human factors
studies with alternative delivery systems
• Examples of development and human factors validation
of innovative delivery systems
Tina Rees, Associate Director, Human Factors, Ferring
12.20 Networking Lunch sponsored by Worrell
13.30 Driving Particles to Zero
• Intrinsic particles: what are the specific challenges
presented by the silicone layer, and silicone oil free
systems?
• Extrinsic particles: supplier to fill finish
• Considerations for combination products
• Case study examples of silicone free devices; what are
the pros and cons?
Ron Forster, Executive Director, Amgen
14.10 COP- Technical data update
• Key properties of COP – demonstrating the value and
characteristics of COP compared with glass
• Case study: Study on protein adsorption/aggregation with
actual protein drug – COP vs. glass
• Case study: study on delamination with glass syringe vs.
COP syringe
• Leachable data on COP syringe with various chemicals
Toshiro Katayama, Senior Product Manager, Zeon
14.50 Controlled depth radiation sterilization for external surface
of ocular syringes
• Challenges for external surface sterilization for syringes
filled with biologics
• Technology concept of controlled depth radiation
• Study results: effect of controlled depth radiation on
lethality, biologic quality, and syringe discoloration
Mayumi Bowen, Senior Engineer, Genentech
15.30 Afternoon Tea and
Networking Break sponsored by
16.00 Innovative technologies in the manufacturing process of
glass pre-filled syringes
• Introduction of a laser-assisted glass cutting technology
resulting in reduced glass particle count, mechanically
stronger and more dimensionally stable finger flanges
• Features and benefits of an innovative X-ray inspection
unit addressing increasing regulatory requirements for CCI
and for drug delivery systems safety
Philippe Lauwers, Business Unit Director Pre-fillable Syringes,
Nipro Pharma Packaging
Matteo Falgari, Business Development Manager Pre-fillable
Syringes, Nipro PharmaPackaging
16.40 Needle clogging in SIN-PFS filled with high concentration
protein solution
• Understanding of the solidification process of mAb
solutions
• Influence of water vapour diffusion through the RNS
during storage
• Considerations on RNS leachables migrating in the drug
product
Monica di Bardi, Postdoctoral Researcher, Roche
17.20 Panel Discussion: The future of parenteral
drug delivery
• Addressing the need and challenges of high
volume injectables:
- Commercial opportunity and challenges
- User considerations
- Technologies: wearable injectors, hand held auto-
injectors & syringes etc.
• Connectivity and connected devices:
- Are they the future of parenteral drug delivery?
Moderated by: Mike Stelmah, Senior Manager,
Combination Products Regulatory Affairs, Regeneron
Derek Mathers, Director of Advanced Applications
Development, Worrell
18.00 Chairman’s Closing Remarks and Close of Day Two
MANUFACTURING DEVELOPMENTS & OPPORTUNITIES
To attend, contact Fateja Begum on Tel +44 (0) 20 7827 6184, Fax +44 (0) 20 7827 6185,
email fbegum@smi-online.co.uk or visit www.smi-online.co.uk/ts05.asp to register online
4. Successful incorporation of Human Factors in prefilled devices
Overview of the workshop:
This workshop will provide guidance
and advice on how to successfully
incorporate human factors into prefilled
devices. Improve your understanding of
human factors for pre-filled syringes in
the context of the whole user interface;
including instructional material, training
and packaging. Learn to succeed in
the application of human factors in pre-
filled devices to enable delivery of high
quality, market leading devices.
Why should you attend this workshop:
• How to successfully incorporate
human factors into device
development
• Considerations for design and
evaluation
• Navigating regulations and seeking
approval
• Ensuring success; case study examples
• How to balance safety, usability and
commercial success
About the workshop leader:
Melanie Turieo is a Director in Cambridge
Consultants’ Global MedTech division,
and Department Leader for Human
Centered Design. Melanie has over 20
years’ experience providing Human
Factors expertise to the design and
development of regulated and safety-
critical items, including medical, military
and consumer products. Her technical
expertise has focused for the last 10
years on human factors engineering
in the design and development of
medical products, and she has extensive
experience designing and conducting
user research for medical devices,
especially drug delivery systems including
injection and inhalation technology.
About the organisation:
Cambridge Consultants develops
breakthrough products, creates IP,
and provides business consultancy in
technology-critical issues for clients
worldwide. For more than 50 years,
they have been helping clients turn
business opportunities into commercial
successes, from launching first-to-market
products, entering new markets to
expanding existing markets through new
technologies. Their auto-injector, inhaler
and injection device development
programs extend from concept creation
through to industrialisation, with a ‘quality
by design’ approach and full compliance
with international regulatory standards.
www.cambridgeconsultants.com
Programme
8.30 Registration & Coffee
9.00 Workshop leaders’ opening remarks
and introduction
9.10 Incorporating human factors
into prefilled device development
• What to consider when making your
device human
- Design intent
- Tests and evaluations
- Seeking regulatory approval – what to
provide to gain regulatory approval
9.40 Case study examples
– common pitfalls vs success stories
10.10 Discussion
10.30 Morning Coffee
11.00 The bigger picture; human factors
as an ecosystem consideration
• Human factors is not a stand-alone
consideration
• Balancing safety, usability and
commercial success
12.00 Discussion
12.30 Workshop leader’s comments
and close of Workshop
Half-Day Post-Conference Workshop
Wednesday 7th June 2017, Hyatt Regency, Mission Bay, San Diego, CA
To attend, contact Fateja Begum on Tel +44 (0) 20 7827 6184, Fax +44 (0) 20 7827 6185,
email fbegum@smi-online.co.uk or visit www.smi-online.co.uk/ts05.asp to register online
Melanie Turieo,
Director, Human
Factors & Industrial Design,
Cambridge Consultants
List of past attendees:
• Abbott Laboratories
• Alkermes
• Allergan
• Amgen
• Anteris Medical GmbH
• Baxalta
• Baxter Healthcare
• Bayer Healthcare
• Bayer HealthCare AG
• BCM Group LLC
• Biogen Inc
• Boehringer Ingelheim
• Boehringer Ingelheim
Pharmaceuticals
Incorporated
• Bosch Packaging
Technology
• Bristol-Myers Squibb Co
• Cambridge Consultants Ltd
• Centurion Medical Products
• DDL
• Eli Lilly
• Emergent BioSolutions Inc.
• ENCO Pharmaceutical
Development, Inc. (EPDI)
• Epione BioPharmaceuticals
• FDA
• Genentech
• Genentech, Inc.
• Getinge A B
• Gilead Sciences
• Gilead Sciences Inc
• Insulet Corp
• IntraCellular Therapies Inc
• Ionis Pharmaceuticals, Inc.
• KBI Biopharma
• LoneStar Heart Inc
• Maeda industry Co Ltd
• Merck, Sharp & Dohme Corp.
• MITSUBISHI GAS CHEMICAL
COMPANY, INC
• Mitsubishi Gas Chemical
Singapore Pte Ltd
• Noxilizer, Inc.
• PAREXEL International
• Pfizer
• Pfizer CentreOne
• Pharmacircle
• Shire
• Shire US Inc
• Steris Corp
• STERIS FINN-AQUA
• Takeda Pharmaceuticals
• Teleflex
• Terumo Americas Holding, Inc
• Terumo Medical
Corporation
• Teva Pharamceuticals
• Teva Pharmaceuticals
• UserWise
• Versartis, Inc.
• W.L. Gore & Associates, Inc.
• Xcelthera
• Xeris Pharmaceuticals
• Xeris Pharmaceuticals, Inc.
• ZebraSCI
• zebrasci inc
• Zeon Chemicals L.P.
Pre-Filled Syringes 2015/2016
Conference Attendee Profile
Networking opportunities at Pre-Filled Syringes West Coast
Regulatory 2%Vendors 20%
Pharmaceuticals
& Biotechnology 78%
5. Pre-Filled Syringes West Coast
Online at www.smi-online.co.uk/ts05.asp
MITSUBISHI GAS CHEMICAL
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 and water vapor barrier. The products make it possible to replace glass with plastic for
injectable drugs. www.mgc.co.jp
NEMERA
Nemera is a world leader in the design, development and manufacturing of drug delivery solutions for pharmaceutical,
biotechnology and generics industries. Nemera’s expertise covers several modes of delivery: Parenteral, Nasal,
Buccal, Auricular, Ophthalmic, Pulmonary, Dermal and 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 and Safelia®, a new generation of 2-steps auto-injector for fluid and viscous formulations. www.nemera.net
NIPRO PHARMAPACKAGING
Nipro PharmaPackaging is specialized in developing and manufacturing advanced pharma packaging products
and complete packaging solutions for early development drugs or enhancement of packaging solutions of existing
drugs. With a worldwide manufacturing footprint of 19 plants, multiple sales offices and lab services, Nipro offers an
exceptional service platform. www.nipro-pharmapackaging.com
OVERLOOK INDUSTRIES
Overlook Industries, Inc. believes that the future of liquid packaging lies in the flexibility to adapt to ever changing
product and customer demands. Overlook Freedom Filler™ kits embody our eighteen year heritage of maximizing
productivity, while providing the ultimate in customization and flexibility. Overlook Freedom Filler™ kits include all
necessary components of the fluid path and can be provided particularly cleaned, multi-bagged and gamma
sterilized per customer requirements. www.ovlk.com
TERUMO PHARMACEUTICAL SOLUTIONS
Terumo Pharmaceutical Solutions offers the pharmaceutical and biotechnology industry unique solutions in medical
technology. In addition to offering our valued products, our specialized team also provides customized and dedicated
solutions designed to meet your specific requirements. www.terumo-ps.com
WORRELL
Worrell is a design firm focused on healthcare innovation. Since 1976, our team of impassioned creatives has applied
the principles of design to the practice of medicine. Today, our clients look to us for our expertise in digital health,
medical device and emerging markets to create better health outcomes. With offices in Minneapolis, Minnesota
and Shanghai, China we are uniquely equipped to apply research, strategy, user experience and industrial design,
engineering, prototyping and human factors engineering capabilities to some of the most complex healthcare
problems globally to meet the needs of patients and providers. www.worrell.com
ZEON
Zeon Chemical’s Zeonex® and Zeonor® cyclo olefin polymers (COP) allow for advanced, break-resistant syringes,
vials and lyophilization containers for protein-based, peptide-based biopharmaceuticals, high viscosity drugs, and
contrast media. They also offer high purity, “glass-like” transparency, sterilization, low water adsorption, and superior
moldability, as well as overcome protein absorption and pH shift concerns. www.zeonex.com
PROUDLY SPONSORED BY:
Supported 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
MARKETING OPPORTUNITIES
Want to know how you can get involved? Interested in promoting your services to this market?
Contact Teri Arri, SMi Marketing on +44 (0) 207 827 6162 or email: tarri@smi-online.co.uk
Official Media Partners
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VENUE Hyatt Regency, Mission Bay, San Diego, CA, USA
PRE-FILLED SYRINGES WEST COAST
Conference: Monday 5th & Tuesday 6th June 2017, Hyatt Regency, Mission Bay, San Diego, CA, USA Workshop: Wednesday 7th June 2017, San Diego, CA, USA
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