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Pre-filled Syringes West Coast 2019
June 3 - June 4, 2019
Pre-filled Syringes West Coast 2019

SAE Media Group's 4th Annual Conference
Pre-Filled Syringes West Coast
June 3 - 4, 2019 | San Diego

Pre-Filled Syringes West Coast will gather a global audience of medical device experts and PFS industry leaders to discuss new developments and showcase the latest and advancements, 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. Pre-Filled Syringes West Coast is the perfect platform to strengthen knowledge in key principles such as human factors and patient centricity, connectivity and digital health, container closure integrity, the therapeutic opportunities of pre-filled, and manufacturing in the landscape of complex biologics, whilst honing in on emerging trends for parenteral devices.

FEATURED SPEAKERS

Benjamin Werner

Benjamin Werner

Scientist, Boehringer Ingelheim
Diane Doughty

Diane Doughty

Senior Scientist, MedImmune
Douglas Cusato

Douglas Cusato

Director of Medical Rubber Business , Sumitomo Rubber
Edmond Israelski

Edmond Israelski

Co-convenor of ISO and IEC Medical Devices Standards Committee, Abbott Laboratories
Hiroki  Hasegawa

Hiroki Hasegawa

Researcher, Mitsubishi Gas Chemical Company, Inc
Jason Fernandez

Jason Fernandez

Drug product formulation and process development scientist, Biogen
Lin Li

Lin Li

Senior Consultant Engineer, Eli Lilly and Company Ltd
Lori Burton

Lori Burton

Senior Principal Scientist, Bristol-Myers Squibb Co
Michael Song

Michael Song

Senior Manager Dosage Form Design and Development, AstraZeneca
Rita Lin

Rita Lin

Human Factors Reviewer, FDA Center for Devices and Radiological Health
Ronald Forster

Ronald Forster

Director Process Development, Amgen
Severine Duband

Severine Duband

Global Category Manager, Nemera
Shannon  E. Clark

Shannon E. Clark

Principal, UserWise, Inc.
Swapnil Pansare

Swapnil Pansare

Scientist, MedImmune
Tina Rees

Tina Rees

Associate Director-Human Factors, Ferring Pharmaceuticals
Toshiro Katayama

Toshiro Katayama

Product Manager, Zeon Specialty materials Inc

Benjamin Werner

Scientist, Boehringer Ingelheim
Benjamin Werner

Benjamin Werner obtained his Master degree in Pharmacy from the University of Munich. After his education Mr. Werner joined the group of Prof. Dr. Gerhard Winter at the Chair of Pharmaceutical Technology and Biotechnology at the University of Munich for his PhD and visited the University of Kansas for a research stay. During his studies he took part in collaborations with the industry and gained experience in the area of protein formulation, stabilization and analysis. In the last years he focused on novel primary packaging materials and other strategies to diminish protein particles in solutions which may cause immunogenicity after administration. Mr. Werner joined Boehringer Ingelheim last year as a Scientist. He is responsible for the primary packaging and process development of parenteral drugs.

Delma L Broussard

Director, CSL Behring
Delma  L Broussard

Delma L. Broussard, MD is a Director, Global Clinical Safety & Pharmacovigilance Physician at CSL Behring. Dr. Broussard received her Bachelor’s and Medical Degrees from Harvard University, and completed Pediatric residency and Gastroenterology training at the Children’s Hospital of Philadelphia.

Her Industry career has spanned 20 years in Risk management of drugs/biologics and medical devices either in PV directly, or as part of Regulatory Affairs or Medical Affairs/Clinical development positions. She currently has a strategic role at CSL Behring, under the Chief Safety Officer, focusing on Clinical safety of combination products and medical devices. Earlier in her career, she held senior roles at major pharmaceutical companies, including Merck & JNJ.
Delma is a board-certified pediatric gastroenterologist, formerly Associate Professor at University of Pennsylvania School of Medicine, with publications in peer-reviewed journals.
 

Diane Doughty

Senior Scientist, MedImmune
Diane Doughty

Diane Doughty is a senior scientist in the Drug Delivery & Device Development group at MedImmune (A Member of the AstraZeneca Group). Her focus is developing combination products for the delivery of peptides and monoclonal antibodies using prefilled syringes, autoinjectors, and pen injectors. Diane has a Ph.D. in Pharmaceutical Sciences from the University of Maryland where she investigated usability of orally inhaled and nasal drug products and the effects of patient-variability on product critical quality attributes.

Douglas Cusato

Director of Medical Rubber Business , Sumitomo Rubber
Douglas Cusato

Douglas Cusato is the Director of the Medical Rubber Business for Sumitomo Rubber, North America . In this role, he is responsible for all aspects of the regional business including Strategy, R&D, Operations and Sales. Douglas has been active in the parenteral packaging industry since 2006 and has served in various technical leadership roles with focus on technology and platform development. He has chaired multiple industry tasks forces and participates in numerous groups as a subject matter expert in elastomeric components for parenteral packaging applications. Doug holds a bachelor’s degree in Chemistry from Rutgers University.

Edmond Israelski

Co-convenor of ISO and IEC Medical Devices Standards Committee, Abbott Laboratories
Edmond Israelski

Ed Israelski is a consultant and the recently retired director of Human Factors at AbbVie, a biopharmaceutical company. He joined the company in 2001, where he led a cross-company team to imbed best-practice human factors engineering HFE design methods into all of AbbVie’s products, to ensure safety and usability. He did this through hands-on design and evaluation of key new products, managing a group of HF professionals; training and mentoring internal resources, writing corporate policy and guidelines and facilitating the use of outside professional HFE resources.

He is the co-convener for IEC and ISO Ergonomic and Usability Engineering groups in developing international Human Factors/Usability medical devices standards. Ed is also past co-chair of the AAMI Human Factors Engineering committee, which develops HF standards for medical devices. He is a certified human factors professional CHFP. He has authored fourteen book chapters and numerous articles in the area of human factors. Ed holds thirty patents. He is a fellow of the Human Factors and Ergonomics Society and a member of the National Academy of Sciences Board on Human-System Integration. He is on the editorial board for the journal Human Factors and serves as a regular reviewer for several other scientific journals.

He has worked as a systems engineer, product manager, market researcher, industrial/organizational psychologist as well as a human factors engineer at various companies including Lucent Technologies - Bell Labs, formerly AT&T, Ameritech/SBC and Human Factors International, Ed is an adjunct instructor at Northwestern University. He received a B.S. in electrical engineering from NJIT, an M.S. in operations research from Columbia University and a Ph.D. in industrial and engineering psychology from Stevens Institute of Technology.
 

Hiroki Hasegawa

Researcher, Mitsubishi Gas Chemical Company, Inc
Hiroki  Hasegawa

Jason Fernandez

Drug product formulation and process development scientist, Biogen
Jason Fernandez

Jason Fernandez is a Senior Scientist in the Protein Pharmaceutical Development group at Biogen. He is responsible for the formulation, manufacturing process development, tech transfer and container development of liquid parenteral dosage forms. Jason has over 18 years of experience focused on therapeutic protein drug product development over multiple companies.

Kesley Gallagher

Director of External Engagement, Combination Products, Amgen Inc.
Kesley Gallagher

Kesley Gallagher is the Director of External Engagement, Combination Products, at Amgen in Thousand Oaks, CA. She has worked in the pharmaceutical and medical device arenas for over 20 years in both Quality Assurance and Regulatory Affairs. Her prior responsibilities include Medical Device Regulation (MDR) implementation for both CE marked devices and products that will require notified body opinion. She led teams for the global submissions and approvals for the Repatha Pushtronex and managed the regulatory aspects of the Neulasta OnPro; these are Amgen’s first on-body injectors. Prior to joining Amgen, Kesley was an RA Manager at Abbott Medical Optics, specializing in new product development for eye care products and ophthalmologic surgical femtosecond lasers. Kesley has an MS in Regulatory Science from the University of Southern California and an BA in Biology/Chemistry from Bowdoin College. When off duty, Kesley is a seasoned expert in fly fishing, and currently holds 10 IGFA world records and won grand champion in the Ladies Tarpon Fly Tournament last spring.

 

Lin Li

Senior Consultant Engineer, Eli Lilly and Company Ltd
Lin Li

Dr. Lin Li is a Senior Consultant Engineer currently working at the Delivery Devices and Connected Solutions team in Eli Lilly and Company. He has gotten his Bachelor’s degree from McMaster University (Canada) and his Ph.D from University of Tennessee in the field of Materials Science and Engineering. He joined Lilly in 2015 and has been part of Lilly’s research on the effort of developing innovative pharmaceutical packaging and devices ever since.

Lori Burton

Senior Principal Scientist, Bristol-Myers Squibb Co
Lori Burton

Lori received her B.S. in Pharmacy from the University of North Carolina at Chapel Hill in 1990 and her Ph.D. in Pharmaceutical Chemistry from the University of Kansas in 1996. She is currently a Senior Principal Scientist in the Parenteral Science and Technology group at Bristol-Myers Squibb and has over 20 years of experience in the development of drug product formulations for proteins, peptides, and small molecules from early through commercial phase.

Michael Song

Senior Manager Dosage Form Design and Development, AstraZeneca
Michael Song

Michael Song leads the Device Functionality, Safety and Digital Connectivity group at MedImmune, a Member of the AstraZeneca Group. In his current role, he oversees device functionality; primary container science and technology; biocompatibility; container closure integrity testing; and digital connectivity. Prior to his current role, Michael was head of Device and Package Engineering at Adello Biologics, a member of Amneal Pharmaceutical. He also has held key engineering lead and toxicology SME positions at Stryker, Kavlico, and other companies. Michael holds a BS in Electrical Engineering from Purdue University and PhD in Neuroscience and Toxicology from Iowa State University.

Natalie Abts

Head of Human Factors Engineering, Genentech
Natalie Abts

Natalie Abts is the Head of Human Factors Engineering at Genentech, where she manages the team that conducts all human factors activities for Genentech’s drug delivery devices. Prior to joining Genentech, Natalie worked in medical device consulting for seven years with the National Center for Human Factors in Healthcare. Natalie has specialized experience in planning and executing both formative stage usability evaluations and validation studies for medical devices and combination products on the FDA approval pathway. Natalie holds a master’s degree in industrial engineering with a focus on human factors and ergonomics from the University of Wisconsin, where she was mentored by Dr. Ben-Tzion Karsh.

Rita Lin

Human Factors Reviewer, FDA Center for Devices and Radiological Health
Rita Lin

Rita Lin joined the U.S. Food and Drug Administration in 2017 as a Human Factors Reviewer in the Center for Devices and Radiological Health (CDRH).
At the FDA, her human factors reviews have focused on general hospital devices such as infusion pumps and pre-filled syringes, respiratory and anesthesia care, and digital health apps. She has been involved in providing edits to numerous standards, FDA guidance development, and teaching at external speaking events with HFES and AAMI, amongst others.
Rita previously worked in the orthopedic devices industry with experience in quality assurance (QA) and research & development (R&D). Her responsibilities included leading major design change projects, conducting empathic interviews, performing verification and validation testing and risk management, and implementing manufacturing process changes in Puerto Rico.
Rita earned her B.S. and M.S. in biomedical engineering and global health from Duke University.
 

Robert Schultheis

President, zebrasci inc
Robert Schultheis

Ronald Forster

Director Process Development, Amgen
Ronald Forster

Dr. Forster is the Executive Director, Device Final Drug Product Technology department at Amgen Inc. Responsible for all Container Closure Systems, their integration into combination products, devices and drug substance systems. His team has developed and published numerous standards for Biological Packaging systems, lead multi-company teams to establish guidance’s in Biological Packaging development, and serves on numerous customer advisory boards for packaging suppliers.

He is also a Board of Director memebnr as well as head of the Technical Advisory Committee for the Suzhou Industrial Park Biologics and Pharmaceutical Packaging institute (Upon accreditation this facility will become the Chinese National Biological Packaging Testing Laboratories)


Prior to joining Amgen, Ron was with Merck Inc. where he was Senior Principle Engineer leading a group that implement Quality by Design for primary packaging systems from early clinical development through commercial supply chain systems. He was a key leader in advancing the Merck Commercialization process and served as a global manufacturing lead on a key product franchise board.

During his tenure at Merck, he also served as an Adjunct Professor at Rutgers University in Biomedical Engineering and Ceramic Engineering.

Ron has an Interdisciplinary Ph.D. from Rutgers University in Chemical Engineering, Ceramic Engineering, and Mechanics and Materials Science.
 

Sarah Sundelacruz

Scientist, Biogen
Sarah Sundelacruz

Sarah Sundelacruz is a Scientist in the Protein Pharmaceutical Development group at Biogen. In her current role, her focus is on formulation development and fill-finish process development for parenteral drug products. Sarah received her B.S. in Biomedical Engineering from Johns Hopkins University and her Ph.D. in Biomedical Engineering from Tufts University.

Severine Duband

Global Category Manager, Nemera
Severine Duband

Séverine DUBAND has joined Nemera in 2018 as Global Category Manager of the parenteral segment. She is responsible for developing the parenteral products, including the passive safety systems Safe’n’Sound®, the innovative autoinjector Safelia®, as well as several other projects.
Graduated from EM Lyon Business School in 2004, Séverine worked 10 years for FMCG in the chemical industry as International Category Manager, supervising strategic planning, NPD launches, project management and brand communication.

Shannon E. Clark

Principal, UserWise, Inc.
Shannon  E. Clark

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 Processional Industrial Engineer, holds two patents, and has written and published three books.
 

Swapnil Pansare

Scientist, MedImmune
Swapnil Pansare

Mr. Swapnil Pansare is Scientist at Medimmune and in his current role, Mr. Pansare is responsible for Drug Product fill finish and process development for liquid and freeze-dried biologics. He is a key member of Process Engineering and Packaging team currently supporting tech transfer of commercial products to commercial site. In his previous role, Mr. Pansare was responsible for developing protein formulations suitable for combination products. He received his MS in pharmaceutical sciences from northeastern university. Mr. Pansare’s research interests include process development, scale up and tech transfer and formulation development for Drug Products (including combination products).

Tina Rees

Associate Director-Human Factors, Ferring Pharmaceuticals
Tina Rees

Tina Rees is the Associate Director of Human Factors at Ferring Pharmaceuticals, where she is responsible for the development and implementation of Human Factors and Usability Engineering processes into the overall product development process. Prior to her move to Ferring, she was a Principal Research Scientist in Human Factors at Eli Lilly, focusing on human factors usability within the diabetes division. She has conducted many formative and summative usability studies and has participated in a number of submissions to regulatory authorities resulting in clearance of medical devices and approval of combination products. She received her Ph.D. in Biomedical Research from the Mayo Clinic in Rochester, MN. She is a strong proponent of human centered design processes and incorporating human factors early into the device development process.

Toshiro Katayama

Product Manager, Zeon Specialty materials Inc
Toshiro Katayama

Toshiro Katayama is the product manager, at Zeon Specialty Materials Inc and responsible in development of Cyclic Olefin Polymer business in the USA. He has over 35 years of various commercial experience, general management, sales and market management, strategic planning, merger and acquisition and purchasing at Gets Bros. & Co Inc (Marmon Group), Union Carbide Corp and Itoh-Chu. He holds Bachelor of Science degree in Mechanical Engineering and Master of Science degree in Structural Engineering from Polytechnic Institute of Brooklyn.

Valerie Fenster

Director of Insights & Human Factors, Kaleidoscope Innovation
Valerie Fenster

Valerie Fenster has thirty plus years’ experience developing intuitively optimized interfaces for critical business applications. She is a persuasive advocate for best practices in human factors engineering and user interaction and is dedicated to developing powerful and user-centered design for combination products, digital health devices and interactive voice response systems.
Valerie is the Director of Insights & Human Factors at Kaleidoscope Innovation in Cincinnati, where she and her team ensure users remain the top consideration in device design solutions. Prior to Kaleidoscope, Valerie founded Amgen’s human factors engineering group and successfully guided many combination products and wearable devices through the HFE process. At Abbot, formerly St. Jude Medical, she helped design and develop their remote care connectivity system for patients with pacemakers or defibrillators.
Valerie currently holds a Master of Science in Human-Computer Interaction from DePaul University in Chicago, Illinois, as well as Bachelor of Arts degrees in both Psychology and Humanities. She is an active member of HFES and AAMI.
 

sponsors

Conference agenda

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8:30

Registration & Coffee

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9:00

Opening Remarks and Introductions

Shannon  E. Clark

Shannon E. Clark, Principal, UserWise, Inc.

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9:10

Principles of Design

Shannon  E. Clark

Shannon E. Clark, Principal, UserWise, Inc.

  • What are the guiding principles of designing a new medical product or selecting a drug delivery device for your new drug?
  • How do I conduct an expert review to uncover design flaws even before entering into usability testing?

     

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    9:50

    Good vs. Bad Design

    Shannon  E. Clark

    Shannon E. Clark, Principal, UserWise, Inc.

  • Study numerous examples of Good vs. Bad Design and start training delegates to see the patterns of good vs. bad design
  • Review the principles of comparative expert reviews - How do I select the best drug delivery platform for my product?
  • Review the principles of informal use error analysis, IEC 62366 PCA task analysis, and use-related risk analysis to uncover use errors
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    10:30

    Morning Coffee

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    11:00

    Interactive Expert Reviews

    Shannon  E. Clark

    Shannon E. Clark, Principal, UserWise, Inc.

  • Delegates will be presented with different real-life medical product prototypes and concepts, and they'll be tasked with conducting an expert review
  • Discuss the principles of identifying whether the product is "optimized" and ready for testing

     

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    11:40

    Closing Remarks from Workshop Leader and End of Workshop

    Shannon  E. Clark

    Shannon E. Clark, Principal, UserWise, Inc.

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    13:00

    Registration & Coffee

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    13:30

    Opening Remarks and Introductions

    Rita Lin

    Rita Lin, Human Factors, Biomedical Engineer, FDA Center for Devices and Radiological Health

    Natalie Abts

    Natalie Abts, Head of Human Factors Engineering, Genentech

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    13:40

    Overview of Human Factors Guidance Documents

  • Review FDA human factors guidance Applying Human Factors and Usability Engineering to Medical Devices
  • Review Xcertia mHealth App Guidelines and discuss relevance to pre-filled syringe industry
  • Discuss current directions and challenges with pre-filled syringes from regulatory and industry perspectives
     
  • Rita Lin

    Rita Lin, Human Factors, Biomedical Engineer, FDA Center for Devices and Radiological Health

  • Review FDA human factors guidance Applying Human Factors and Usability Engineering to Medical Devices
  • Review Xcertia mHealth App Guidelines and discuss relevance to pre-filled syringe industry
  • Discuss current directions and challenges with pre-filled syringes from regulatory and industry perspectives
     
  • Natalie Abts

    Natalie Abts, Head of Human Factors Engineering, Genentech

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    14:20

    Case Study Introduction

  • Case study product overview – testing a pre-filled syringe utilizing Bluetooth to communicate with an accompanying app
  • Discussion of risk analysis and risk considerations for this type of product
  • Preliminary discussion and review of product documentation
     
  • Rita Lin

    Rita Lin, Human Factors, Biomedical Engineer, FDA Center for Devices and Radiological Health

    Natalie Abts

    Natalie Abts, Head of Human Factors Engineering, Genentech

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    15:00

    Afternoon Tea

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    15:30

    Validation Study Planning

  • Discuss key components of a good validation study design
  • FDA perspective on common problems with validation plans
  • Industry perspective on problem-solving for difficult-to-test products
  • Rita Lin

    Rita Lin, Human Factors, Biomedical Engineer, FDA Center for Devices and Radiological Health

  • Discuss key components of a good validation study design
  • FDA perspective on common problems with validation plans
  • Industry perspective on problem-solving for difficult-to-test products
  • Natalie Abts

    Natalie Abts, Head of Human Factors Engineering, Genentech

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    16:10

    Creating a Study Plan

  • Work time to create a validation study plan for the device introduced during Session 2
  • Team report out of study plans
  • Discussion of lessons learned from the exercise
  • Rita Lin

    Rita Lin, Human Factors, Biomedical Engineer, FDA Center for Devices and Radiological Health

    Natalie Abts

    Natalie Abts, Head of Human Factors Engineering, Genentech

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    16:50

    Closing Remarks from Workshop Leaders and End of Workshop

    Rita Lin

    Rita Lin, Human Factors, Biomedical Engineer, FDA Center for Devices and Radiological Health

    Natalie Abts

    Natalie Abts, Head of Human Factors Engineering, Genentech

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    8:20

    Registration & Coffee

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    9:00

    Co-Chair's Opening Remarks

    Michael Song, Senior Manager Dosage Form Design and Development, AstraZeneca

    Tina Rees, Associate Director-Human Factors, Ferring Pharmaceuticals

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    9:10

    Platform approach for combination products and devices

    • HFE assessment considerations
    • Challenges in biocompatibility
    • The balance between volume and viscosity
    • The future of the platform approach for devices
     

    Ronald Forster, Director Process Development, Amgen

    Kesley Gallagher, Director of External Engagement, Combination Products, Amgen Inc.

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    9:45

    Elastomeric Components: Supporting Next Generation Drug Delivery Systems

    Douglas Cusato, Director of Medical Rubber Business , Sumitomo Rubber

  • How can innovation in elastomeric components support PFS & next generation drug delivery systems?
  • How can a suppliers manufacturing network support PFS & next generation drug delivery systems?
  • What can we learn from other industries and apply it to future innovations and support drug delivery innovations?
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    10:25

    Innovative Application of Computer Aided Engineering in Development of Pharmaceutical Packaging

    Lin Li, Senior Consultant Engineer, Eli Lilly and Company Ltd

  • Simulation led design
  • Device mechanism optimization
  • Container closure integrity at various shipping condition
  • Injection Physiology
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    11:00

    Morning Coffee Sponsored by Zeon

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    11:30

    Multilayer plastic syringe with excellent oxygen and UV barrier

    Hiroki  Hasegawa

    Hiroki Hasegawa, Researcher, Mitsubishi Gas Chemical Company, Inc

    • Excellent oxygen and UV barrier contribute to stability of biologics
    • Optimized silicone-oil contributes to preventing protein aggregation
    • Extremely low levels of extractables contribute to stability of biologics
    • Development of staked needle syringes
     

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    12:10

    Development of user-centric requirements for prefilled syringes and injection devices

    Diane Doughty, Senior Scientist, MedImmune

  • Review of user-centric device characteristics
  • Generating user-relevant design input requirements
  • Applying a platform approach to user-centric devices
     
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    12:45

    Networking Lunch

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    13:45

    Human Factors Guidelines for Mobile Health Applications

    Natalie Abts, Head of Human Factors Engineering, Genentech

  • Background on development process
  • Guidelines content review
  • Details on development and application of usability guidelines
  • Practical ways to apply guidelines to development
     
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    14:20

    Digital Health, considerations when developing digital connectivity solutions

    Michael Song, Senior Manager Dosage Form Design and Development, AstraZeneca

  • Explore the use of wireless communication systems beyond Bluetooth
  • Explore advantages and disadvantages between using add-on vs. add-in
  • How much data is enough data
  • Regulatory considerations and challenges

     

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    14:55

    FDA Training Decay Research Initiative – Is a 1-hour training decay long enough for summative usability testing?

    Shannon E. Clark, Principal, UserWise, Inc.

  • Identify differences in decay between device types
  • The effects of accelerated decay
  • Assessing the task-training decay curve profiles
  • Identify generalizable detailed training decay curves
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    15:30

    Afternoon Tea Sponsored by Zeon

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    16:00

    Panel Discussion: Future Regulatory Trends

    • The European Medical Device Regulation
    • The emerging market in China
    • Brexit and how it will affect the device industry
    • Regulatory strategies for wearables, software-based medical devices and integrated devices
     

    Ronald Forster, Director Process Development, Amgen

    Kesley Gallagher, Director of External Engagement, Combination Products, Amgen Inc.

    Natalie Abts, Head of Human Factors Engineering, Genentech

    Robert Schultheis

    Robert Schultheis, President, zebrasci inc

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    16:35

    Overview of EU MDR specific to safety

    Delma L Broussard, Director, CSL Behring

  • Overview of requirements for EU MDR
  • Discuss new requirements for post-market surveillance
  • Integration of post-market surveillance activities with risk management and clinical evaluation

     

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    17:10

    Chairman’s Closing Remarks and Close of Day One

    Michael Song, Senior Manager Dosage Form Design and Development, AstraZeneca

    Tina Rees, Associate Director-Human Factors, Ferring Pharmaceuticals

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    8:30

    Registration & Coffee

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    9:00

    Chairman's Opening Remarks

    Michael Song, Senior Manager Dosage Form Design and Development, AstraZeneca

    Tina Rees, Associate Director-Human Factors, Ferring Pharmaceuticals

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    9:10

    Digital health applications

    Edmond Israelski, Co-convenor of ISO and IEC Medical Devices Standards Committee, Abbott Laboratories

  • Mobile applications that support drug delivery
  • The benefits of digital health and patient compliance
  • User interface developments
  • Advances in connectivity
     
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    9:45

    Human Factors Submission Expectations: a CDRH perspective

    Rita Lin, Human Factors Reviewer, FDA Center for Devices and Radiological Health

  • General overview of the CDRH 2016 human factors guidance document
  • Best practices, including current review statistics
  • Case Studies comparing CDRH medical device and combination product HF submissions
     
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    10:20

    Pain perception and injection devices: could pain be assessed through non-human person trials in early stage device development?

    Severine Duband, Global Category Manager, Nemera

  • Pain perception key drivers during injection
  • Can a study on NHP evaluate pain associated to injection?
  • Application of NHP model on testing customization and technical improvements on injection devices to limit pain
     
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    11:00

    Morning Coffee Sponsored by Zeon

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    11:30

    Human Factor considerations for pre-filled syringes

    Tina Rees, Associate Director-Human Factors, Ferring Pharmaceuticals

  • Human Factor considerations for pre-filled syringesNew product design and development
  • Approaching a regulatory submission
  • Advancements in human factors for pre-filled syringes
  • Considerations for patient centricity
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    12:05

    Prefilled syringes + Safety Devices = Fun with Users

    Valerie Fenster, Director of Insights & Human Factors, Kaleidoscope Innovation

  • An overview of add-on safety accessories
  • Ingenious ways safety accessories are used
  • Tips and tricks for proper instructions
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    12:45

    Panel Discussion: Improving patient centricity through digital health

  • Optimising user interface tools
  • How to improve patient compliance
  • Overcoming cyber security challenges
  • The benefits of digital health and patient compliance

     

  • Edmond Israelski, Co-convenor of ISO and IEC Medical Devices Standards Committee, Abbott Laboratories

    Diane Doughty, Senior Scientist, MedImmune

    Michael Song, Senior Manager Dosage Form Design and Development, AstraZeneca

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    13:20

    Networking Lunch

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    14:20

    Viscosity Challenges for Design and Development of Combination products for Subcutaneous Administration

    Swapnil Pansare, Scientist, MedImmune

  • Combination products (i.e., accessorized prefilled syringes and autoinjector) for SC administration have different requirements for maximum viscosity to meet the device functionality (i.e. glide force & injection time) criteria
  • Protein formulations may show shear thinning behaviour (i.e. decrease in viscosity as shear rate increases), thereby impacting device functionality
  • Viscosity limit for combination products was significantly higher due to shear thinning observed for protein formulations
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    14:55

    Technical updates in Cyclo Olefin Polymer (COP) – A Case Study

    Toshiro Katayama, Product Manager, Zeon Specialty materials Inc

  • Key Properties of COP
  • Case study:  Biologics formulation for COP syringe optimized to eliminating use of surfactant.
  • Case study:  Study on Protein adsorption/aggregation – COP vs glass
  • Case study:  Study on delamination with glass syringe vs COP syringe
  • Leachable data on COP syringes with various chemicals
     
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    15:35

    Impact of silicone oil free polymer syringes on therapeutic proteins

    Benjamin Werner, Scientist, Boehringer Ingelheim

  • Advantages and disadvantages of glass and polymer syringes
  • Long-term protein stability for polymer systems
  • Oxygen permeation of polymer syringes
  • Nitrogen filled pouches for polymer syringe storage
     
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    16:10

    Afternoon Tea Sponsored by Zeon

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    16:40

    Drug Product Development Considerations for Subcutaneous Delivery of Proteins

    Sarah Sundelacruz, Scientist, Biogen

  • There are a number of considerations when developing protein drug products for subcutaneous delivery, this talk will highlight some common considerations:
  • Managing the viscosity of liquid formulations for high concentration products.
  • Drug product manufacturing parameter development for SC administered products
  • Managing subcutaneous primary container compatibility and interactions with protein formulations for SC delivery.
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    17:15

    Understanding and Controlling the Risk of Protein Aggregation in Siliconized Pre-Filled Syringes

    Lori Burton, Senior Principal Scientist, Bristol-Myers Squibb Co

  • Biologics products, packaged in pre-filled syringes, can sometimes show physical instability due to the silicone oil used to lubricate the syringe barrel.
  • The following will be reviewed:
  • Nature of the interaction between proteins and silicone oil
  • Common approaches for mitigating the risk of silicone oil-induced instability
     

     

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    17:50

    Chairman’s Closing Remarks and Close of Day Two

    Michael Song, Senior Manager Dosage Form Design and Development, AstraZeneca

    Tina Rees, Associate Director-Human Factors, Ferring Pharmaceuticals


    Scientist
    Boehringer Ingelheim
    Director
    CSL Behring
    Senior Scientist
    MedImmune
    Director of Medical Rubber Business
    Sumitomo Rubber
    Co-convenor of ISO and IEC Medical Devices Standards Committee
    Abbott Laboratories
    Researcher
    Mitsubishi Gas Chemical Company, Inc
    Drug product formulation and process development scientist
    Biogen
    Director of External Engagement, Combination Products
    Amgen Inc.
    Senior Consultant Engineer
    Eli Lilly and Company Ltd
    Senior Principal Scientist
    Bristol-Myers Squibb Co
    Senior Manager Dosage Form Design and Development
    AstraZeneca
    Head of Human Factors Engineering
    Genentech
    Human Factors Reviewer
    FDA Center for Devices and Radiological Health
    President
    zebrasci inc
    Director Process Development
    Amgen
    Scientist
    Biogen
    Global Category Manager
    Nemera
    Principal
    UserWise, Inc.
    Scientist
    MedImmune
    Associate Director-Human Factors
    Ferring Pharmaceuticals
    Product Manager
    Zeon Specialty materials Inc
    Director of Insights & Human Factors
    Kaleidoscope Innovation

    Sponsors and Exhibitors

    Official Media Partner

    Supporters

    2019 PROGRAMME

    Download

    Preliminary Attendees list (28 May)

    Download

    Interview with Dr Delma Broussard, CSL Behring

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    An interview with Shannon E. Clark, UserWise, Inc.

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    Presentation by Tina Kiang, FDA

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    Presentation by Michael Song, MedImmune

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    Presentation by Carl Dabruzzi, West Pharmaceutical Services

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    News Release from ZwickRoell

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    Interview with DOUGLAS CUSATO, Sumitomo Rubber

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    Development of Pre-Filled Syringe Packaging - Plastic Ingenuity

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    Development Guide for Automated Healthcare Packaging - Plastic Ingenuity

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    2019 Speaker Biographies

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    2018 Attendees

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    Interview with NATALIE ABTS, MedStar Health

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    Workshop programme

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    CHAIR LETTER

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    Past Attendee Breakdown - INFOGRAPHICS

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    Presentation by Veneza Yuzon, Amgen

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    Presentation by Michael Song, MedImmune

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    Presentation by Paul Upham, Roche

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    Presentation by Larry Atupem, Zeon

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    Presentation by David Post, Abbvie

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    Presentation by KALBERMATTEN FRANZESE, Terumo

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    Presentation by Shota Arakawa, Mitsubishi Gas Chemical

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    Sponsors and Exhibitors


    Almac Group

    Sponsors and Exhibitors
    http://www.almacgroup.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
    • - Labeling, assembly and secondary packaging
    • - Complex kit assembly
    • - Temperature sensitive storage
    • - Serialization
    Our wide range of services and flexibility to handle projects of any size, makes us your preferred US packaging partner.


    Aptar Pharma

    Sponsors and Exhibitors
    http://www.aptar.com/pharma

    Aptar Pharma is a leading provider of innovative drug delivery systems to pharmaceutical, consumer healthcare and biotech customers worldwide, enabling safe, convenient and compliant medication delivery. Trusted partner of the pharmaceutical community, we provide our customers with a large range of specialized drug delivery devices, components and analytical services backed by decades of proven expertise. We have broad therapeutic expertise in Nasal, Pulmonary, Injectables, Eye Care and Dermal delivery routes, among others. Our global manufacturing footprint of sites in Argentina, China, France, Germany, India, Switzerland and the U.S. provides security of supply and local support to our customers. For more information visit: www.aptar.com/pharma


    Credence MedSystems

    Sponsors and Exhibitors
    http://www.credencemed.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.


    Harro Höfliger

    Sponsors and Exhibitors
    http://www.hoefliger.com

    Harro Höfliger specializes in the development of customer-oriented process and production solutions for pharmaceutical and medical applications as well as market-oriented consumer products. In addition to innovative machine platforms and packaging machines, customized turnkey system solutions for product assembly, processing of web materials, as well as dosing and inhalation technology are the company’s core expertise.

    The systematically structured portfolio of upscalable test machines and modules, as well as requirement-oriented technology platforms, results from many years of experience and targeted research and development. Thus, Harro Höfliger covers all phases from the laboratory stage to high-performance production.



    Kaleidoscope Innovation

    Sponsors and Exhibitors
    http://www.kascope.com

    Founded in 1989, Kaleidoscope Innovation is a full-service, insights, design and development firm. Offering consultancy-style and onsite services, Kaleidoscope Innovation helps business partners solve challenges through: Insights & Human Factors, Industrial Design & User Experience, Engineering, Visualization and Software Development. Kaleidoscope Innovation has ISO 13485:2016 certification and IEC 60601 compliant.


    Lonstroff

    Sponsors and Exhibitors
    http://www.lonstroff.com

    Lonstroff is a partner that offers all services related to elastomeric solutions from a single source. We advise our customers not only in the new development and optimization of materials, but also in their applications and in value analysis. Thanks to our experience, we are also able to provide valuable support with the registration and approval of the products.


    Mitsubishi Gas Chemical

    Sponsors and Exhibitors
    https://www.mgc.co.jp/eng/products/abd/oxycapt.html

    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.


    Nemera

    Sponsors and Exhibitors
    http://www.nemera.net

    As a world-leading drug device combination solutions specialist, our purpose of putting patients first enables us to design and manufacture devices that maximize treatment efficacy. We are the utmost holistic partner and help our customers succeed in the sprint to market. From early device strategy to state-of-the-art manufacturing, we’re committed to the highest quality standards. Agile and open-minded, we work with our customers as colleagues. Together, we go the extra mile to fulfill our mission. 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 - Wearables, technological bricks combined together into a smart wearable to improve patients’ life.


    PHC Corporation

    Sponsors and Exhibitors
    http://www.phchd.com/global/

    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.


    Plastic Ingenuity

    Sponsors and Exhibitors
    http://www.plasticingenuity.com

    Plastic Ingenuity is a custom thermoformer that provides packaging for the drug delivery and pharmaceutical markets. We specialize in creating secondary packaging for pharmaceutical combination products and automation trays that integrate into high volume assembly equipment for our drug delivery partners. These parts run flawlessly on highly complex automated equipment.


    Sumitomo Rubber Industries

    Sponsors and Exhibitors
    http://hybrid.srigroup.co.jp/en/products/cleanrubber/

    Since our founding in 1909 as the first modern rubber factory in Japan, we at Sumitomo Rubber Industries have strived to produce advanced, environmentally friendly products based on the latest innovations in rubber technology. Within the medical rubber group, we are focused on providing the highest quality products, and ultimately dedicated to improving the lives of people around the world. Utilizing the latest in material and process innovations and our global manufacturing footprint, our team members work diligently to ensure we deliver consistent high performing products and provide strong assurance of supply.


    WILCO

    Sponsors and Exhibitors
    http://www.wilco.com

    WILCO provides in-line, off-line and laboratory machines with non-destructive and data-driven testing methods for monitoring the gas concentration in the head space and container closure integrity (CCI) simultaneously. Our patented leak detection methods based on the process analytical technologies (PAT) offer the opportunity for monitoring the finishing processes as well.


    Zebrasci

    Sponsors and Exhibitors
    http://www.zebrasci.com

    ZebraSci is an independent, third party laboratory and a trusted partner for pharma and med device. Our cross-functional team is geared to deliver informed & integrated solutions for your device and packaging development projects. Operating through two dedicated Centers of Excellence (CoE), with over 20,000 ft2 of laboratory and manufacturing space between our East Coast & West Coast Facilities, we offer solutions throughout your entire product life-cycle, ensuring that your product is launched on time and on budget.


    ZEON

    Sponsors and Exhibitors
    http://www.zeonex.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.

    Media Partners


    ONdrugDelivery Magazine

    Official Media Partner
    http://ondrugdelivery.com

    ONdrugDelivery provides 30,000 readers throughout global pharma/biopharma, with the latest, most pertinent industry information and intelligence about the drug delivery-related ideas, technologies, services and products the sector is developing. Established in 2004, and trusted throughout the industry for its high quality contributions from leading drug delivery experts, ONdrugDelivery is a must for pharma / biotech industry professionals who need to know what’s going on in drug delivery. Subscribe online today to the print or free digital edition: www.ondrugdelivery.com/subscribe.

    Media Partners


    Drug Discovery Today

    Supporters
    http://www.drugdiscoverytoday.com/

    Drug Discovery Today covers the whole of the preclinical drug discovery process. The reviews are cutting edge, written by experts in their respective fields and cover all aspects of drug discovery from genomic and proteomic approaches, computational drug design, medicinal chemistry and the translation of these sciences to therapies.


    CanBiotech

    Supporters
    http://www.canbiotech.com

    CanBiotech - A Portal and B2B Outsourcing Marketplace for the Biotech and Pharmaceutical Industry. The Marketplace features the Outsourcing Services Showcase; the Portal features our biopharmaceutical and venture capital directories and databases. Publications include the BioMedical Outsourcing Report and the Bio Outsourcing Asia© Publication.


    World Pharma News

    Supporters
    http://www.worldpharmanews.com/



    Drug Development Technology

    Supporters
    http://www.drugdevelopment-technology.com

    Drugdevelopment-technology.com covers every aspect of the drug development and research process, from conception to pre-FDA approval. Our global network of journalists updates the site with the latest and most significant industry developments. This coverage allows us to provide everyone - from senior management through to research and QA staff – with in-depth reviews of the latest projects, advance notice of new product releases and analysis of the latest procedural and legislative developments.


    Pharmalicensing

    Supporters
    http://www.pharmalicensing.com

    Pharmalicensing (www.pharmalicensing.com) is the premier biopharmaceutical Open Innovation resource designed for professionals involved with partnering, licensing and business development worldwide. Actively supporting all forms of partnering and in- and out-licensing activities, Pharmalicensing utilizes the unique online Showcase Profiling & Discover services, as well as its renowned Partnering Search service leveraging its global network of industry experts, to enable companies to identify and engage with appropriate partners around the world. Pharmalicensing is actively utilized by many tens of thousands of industry professionals each month. Pharmalicensing is a division of Cognis Group, Inc


    PharmaVOICE

    Supporters
    http://www.pharmavoice.com

    PharmaVOICE magazine, and its supporting VIEW publications, provide commentary about the challenges and trends impacting the life-sciences industry, covering a range of issues from molecule through market. PharmaVOICE's more than 41,000 U.S.-based subscribers are also kept abreast of the latest trends through additional media resources, including WebSeminars, Podcasts, Videocasts, and White Papers.


    Pharmiweb

    Supporters
    http://www.pharmiweb.com

    Established in October 2003, PharmiWeb Solutions is an energetic, innovative provider of web-based solutions for the pharmaceutical sector, with customers such as AstraZeneca, Roche, Servier Laboratories, and Merck With solutions in three key areas: Online Publishing, e-Business and Mobile Computing, we deliver connectivity – between people and applications – unlocking islands of data and knowledge. We own some of the sector’s most innovative Online Publications: PharmiWeb.com, HospitalPharma.com and Detail-Direct.com. We are actively developing solutions for Mobile Computing platforms. For example, our PharmiTabTM e-pharmacy solution runs real-time patient data and prescribing transactions in a busy hospital environment, on a TabletPC, wireless client/server platform. e-Business solutions range from e-Detailing, to Online Market Research, all designed to increase reach, increase sales, and to reduce administration and costs.


    Gate2Biotech

    Supporters
    http://www.gate2biotech.com

    Gate2Biotech is a portal that unites biotechnological community in Central Europe. It covers all the news in the field of biotechnology. Thanks to the the portal the companies engaged in the field can easily search for research institutions and other partners to solve technical problems they are facing and here they can also present their services offer to potential partners from the Czech Republic and abroad. Gate2Biotech portal serves as a bridge connecting scientific and commercial sector. It incorporates offices and support organizations dedicated to promoting transfer of innovative technologies into a unified communication platform of Czech and international biotechnologies. As a mediator of information it draws attention to biotechnologies and support of their application and transfer into practice. It also functions as a tool for encouraging non-professionals (especially scientists and students) towards innovative business or applied research.


    Technology Networks

    Supporters
    http://go.technologynetworks.com/subscribe-to-newsletters

    Founded in 2000, Technology Networks is established as the leading news provider for life science and drug discovery professionals. In addition, we provide unique content including webcasts, videos, application notes and posters from recent conferences. Our portfolio now includes around 30 focussed scientific communities, all of which are accessible free of charge within TechnologyNetworks.com


    Pharmaceutical Outsourcing

    Supporters
    http://www.pharmoutsourcing.com

    Pharmaceutical Outsourcing, the journal dedicated to pharmaceutical and biopharmaceutical contract services. With regular sections on contract manufacturing, contract research, contract packaging, formulation/development services, contract analytical testing, APIs, stability testing, clinical research and other areas, we bring the most complete coverage of trends and issues in the industry to our 15,000 readers in North America.


    American Pharmaceutical Review

    Supporters
    http://www.americanpharmaceuticalreview.com

    Start receiving your free copy today. American Pharmaceutical Review is a review of the drug pipeline from the late discovery phase through manufacturing. American Pharmaceutical Review prides itself on having the most relevant, unbiased and informative editorial in the industry. You will find that all of our editorial is highly technical and written by government agencies, consultants, academics, and large pharmaceuticals companies. American Pharmaceutical Review covers several key topics that are important to drug production:Separations and purification, Drug Delivery, Biopharmaceutical Processing, Biopharmaceutical Development, Formulation development, Manufacturing, Microbiology, Instrumentation, Spectroscopy


    Pharmaceutical Technology

    Supporters
    http://www.pharmaceutical-technology.com

    Pharmaceutical-technology.com is the only website focusing specifically on issues relevant to pharmaceutical professionals working with technology, be it development, engineering, IT or production. Pharmaceutical-technology.com brings you the latest in industry projects and updates, along with the news, views and trends that leading professionals – from senior executives to manufacturing managers and heads of procurement – require to stay on top of their field.


    pharmaphorum

    Supporters
    http://www.pharmaphorum.com

    pharmaphorum drives innovation within the pharmaceutical industry, by bringing healthcare together through a suite of media services that help produce and disseminate thought leadership, combined with an online platform for communicating messages to a global audience.Visit www.pharmaphorum.com


    Pharmacircle

    Supporters
    http://www.pharmacircle.com

    PharmaCircle is an innovative knowledge management company serving the current and future global leaders in the Pharmaceutical and Biotechnology related industries. PharmaCircle is a one stop information and analysis source for pipeline, products, clinical trials, drug delivery technologies, deals and acquisitions, company financials, venture capital investments, product sales, pharmaceutical services, news, patents and more….


    Mednous

    Supporters
    http://www.MedNous.com

    MedNous is a print publication and website about medical innovation in Europe. It carries exclusive interviews with companies that are at the forefront of medical technology, as well as contributor articles from prominent practitioners. Our mission is to identify significant advances in medicine and to explain how this innovation is being commercialised. In doing so, we talk to venture capitalists about what products and platforms they are supporting. We report on how regulators cope with the accelerating pace of innovation. And we regularly cover the latest developments in the discovery and development of new medical concepts in the area of antibodies, vaccines, small molecules, regenerative medicine and nanomedicines. MedNous combines the English word for medicine with the Greek word for intellect. And those with nous are readers of our publication. Visit our website: www.mednous.com


    Farmavita

    Supporters
    https://farmavitar.com

    FarmavitaR+ is the professional network of experts and service providers. Network is gathering local consultants from 90 countries in Europe, Asia, North America, Latin America, Australia and Africa. Management of international, multi-centre projects is our core competence. FarmavitaR+ is providing solutions related to pharmaceutical, medical device, food supplement and cosmetic products. Scope of services is related to solutions for product development, quality assurance, clinical trials, product registration, portfolio analysis, lifecycle management, vigilance/risk management, pricing/reimbursing, market access and promotional compliance. FarmavitaR+ is brand name of Farmavita Regulanet Ltd. Visit https://farmavitar.com for more information. Outsource anything you can think of!


    pharmanews hq

    Supporters
    http://http://pharmanewshq.com

    MedChemNet provides a unique and unparalleled platform for the medicinal chemistry community to share insights, discuss the latest research, and help move the field forward. MedChemNet covers all aspects of the drug discovery pipeline, from target identification and validation, through computer aided drug design (CADD), synthesis, screening and other biophysical techniques, to development of novel lead compounds and pre-clinical in vivo proof of concept. We also cover the design of synthetic drug delivery carriers and ADME/toxicology studies, as well as intellectual property and economic related issues. Website: Welcome to Pharma News HQ, the journal dedicated to the pharmaceutical and biopharmaceutical contract services. With regular sections on contract manufacturing, contract research, contract packaging, formulation/development services, contract analytical testing, APIs, stability testing, clinical research and other areas, we bring the most complete coverage of trends and issues in the industry. Pharmanewshq.com is the only website focusing specifically on issues relevant to pharmaceutical professionals working with technology, be it development, engineering, IT or production.


    Pharma Journalist

    Supporters
    http://www.pharmajournalist.com

    Pharma Journalist is a product of Kellen Media. Pharma Journalist is one of the leading website covering the need of global Pharmaceutical Industry. Articles like latest news, trends, analysis, market report, press releases, whitepapers, case studies, etc. published on pharmajournalist.com helps Industry professionals and decision makers to stay on the top of this fast-paced industry. Pharma Journalist aims of providing fast and informative articles to its readers and subscribers.


    Biocompare

    Supporters
    http://www.biocompare.com

    Biocompare.com is the leading resource for up-to-date product information, product reviews, and new technologies for life scientists. Biocompare combines an in-depth knowledge of life science products and new technologies with the power of the Internet to offer scientists the most dynamic, relevant, and innovative media-based marketplace for life science information.


    Pharmavision

    Supporters
    http://www.pharmavision.co.uk

    PharmaVision offers a consultancy service providing independent pharmaceutical thematic research to the healthcare industry, the investment community and competitive intelligence specialists. We perform due diligence research and provide expert commentary in healthcare. Our reports combine scientific analysis in drug delivery, R&D technologies and pharmaceutical products including patient modelling, product/technology forecasts and market trends evaluation.


    IPI

    Supporters
    http://www.ipimediaworld.com

    IPI – International Pharmaceutical Industry Established by professionals with over 30 years experience in the Pharmaceutical and Life sciences publishing sectors. We have identified the needs of these dynamic industries, and have listened carefully to our readers and advertisers. With strong collaboration between Pharmaceutical and Life sciences Industry Associations we have created a global distribution network. We give you a promise to become a reliable extension of your marketing and communication arm. If necessary we will integrate our expertise with your needs. Incorporating new and innovative communication methods we will help to highlight your expertise.

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    WHAT IS CPD?

    CPD stands for Continuing Professional Development’. It is essentially a philosophy, which maintains that in order to be effective, learning should be organised and structured. The most common definition is:

    ‘A commitment to structured skills and knowledge enhancement for Personal or Professional competence’

    CPD is a common requirement of individual membership with professional bodies and Institutes. Increasingly, employers also expect their staff to undertake regular CPD activities.

    Undertaken over a period of time, CPD ensures that educational qualifications do not become obsolete, and allows for best practice and professional standards to be upheld.

    CPD can be undertaken through a variety of learning activities including instructor led training courses, seminars and conferences, e:learning modules or structured reading.

    CPD AND PROFESSIONAL INSTITUTES

    There are approximately 470 institutes in the UK across all industry sectors, with a collective membership of circa 4 million professionals, and they all expect their members to undertake CPD.

    For some institutes undertaking CPD is mandatory e.g. accountancy and law, and linked to a licence to practice, for others it’s obligatory. By ensuring that their members undertake CPD, the professional bodies seek to ensure that professional standards, legislative awareness and ethical practices are maintained.

    CPD Schemes often run over the period of a year and the institutes generally provide online tools for their members to record and reflect on their CPD activities.

    TYPICAL CPD SCHEMES AND RECORDING OF CPD (CPD points and hours)

    Professional bodies and Institutes CPD schemes are either structured as ‘Input’ or ‘Output’ based.

    ‘Input’ based schemes list a precise number of CPD hours that individuals must achieve within a given time period. These schemes can also use different ‘currencies’ such as points, merits, units or credits, where an individual must accumulate the number required. These currencies are usually based on time i.e. 1 CPD point = 1 hour of learning.

    ‘Output’ based schemes are learner centred. They require individuals to set learning goals that align to professional competencies, or personal development objectives. These schemes also list different ways to achieve the learning goals e.g. training courses, seminars or e:learning, which enables an individual to complete their CPD through their preferred mode of learning.

    The majority of Input and Output based schemes actively encourage individuals to seek appropriate CPD activities independently.

    As a formal provider of CPD certified activities, SAE Media Group can provide an indication of the learning benefit gained and the typical completion. However, it is ultimately the responsibility of the delegate to evaluate their learning, and record it correctly in line with their professional body’s or employers requirements.

    GLOBAL CPD

    Increasingly, international and emerging markets are ‘professionalising’ their workforces and looking to the UK to benchmark educational standards. The undertaking of CPD is now increasingly expected of any individual employed within today’s global marketplace.

    CPD Certificates

    We can provide a certificate for all our accredited events. To request a CPD certificate for a conference , workshop, master classes you have attended please email events@saemediagroup.com

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    Contact SAE Media Group

    UK Office
    Opening Hours: 9.00 - 17.30 (local time)
    SAE Media Group , Ground Floor, India House, 45 Curlew Street, London, SE1 2ND, United Kingdom
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