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6th Annual Pre-Filled Syringes & Injectables Summit

  • 26th – 27th November 2020
  • Austria flag Austria Vienna

During the 2-days networking experience, we will discuss the demand for efficient and convenient-to-use drug delivery devices that are used to improve patients’ experience and the key factors for the market growth advancing the technology.  

Get acquainted and network with industry leaders to disclose new horizons and developments in pre-filled syringes (PFS) and injectable devices. The 6th edition of the Pre-Filled Syringes & Injectables Summit will help you answer the most pressing industry challenges.  

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About

The demand for efficient and convenient-to-use drug delivery devices and improving a patient's experience are key factors for the market growth advancing the technology.

This event has been designed for industry leaders to disclose new horizons and developments in pre-filled syringes (PFS) and injectable devices. Attending this event will provide a broad overview of current and upcoming EU MDR regulatory require­ments, innovative technologies, the impact of digitalisation, market trends and device needs. We will discuss the benefits of PFS and injection devices as the main factor for dosage ac­curacy, convenience and safe treatment for patients.

We are excited to be hosting the 6th edition of our Pre-Filled Syringes & Injectables Summit and look forward to meeting you in Vienna in November!

Who Should Attend 

Chief Executives, Directors, Vice Presidents, Department Heads, Leaders, Senior Managers, Principal Scientists, Chemists and Engineers specialising in:

  • Bioprocess Research & Development
  • Business Development
  • CMC
  • Combination Products
  • Container Development
  • Controls & Robotics
  • Device Development & Manufacturing
  • Device Engineering & Design
  • Drug Delivery & Devices
  • Drug Development
  • Drug Packaging
  • External Supply
  • Extractables & Leachables
  • Fill/Finish
  • Formulation Sciences
  • Human Factors
  • Injectables
  • Materials Development
  • Medical & Connected Devices
  • Parenterals
  • PFS
  • QA/QC
  • Regulatory Affairs
  • Research & Development
  • Risk Management
  • Stability
  • Standardisation Science
  • Smart Devices
  • Sterile Products
  • Vaccines
  • Validation

BOOK YOUR SEAT NOW

REQUEST A BROCHURE

To request an agenda for this Summit, please complete the details below. We will send you the agenda via email.

Key Practical Learning Points

  • Overview of the upcoming EU MDR regulation and the role of notified bodies
  • Devices for self-injection: engineering challenges, trends and new developments
  • Strategic design: enhancing differentiation through a style guide
  • Integrating quality requirements
  • Analytical studies and chemical safety assessment
  • Manufacturing and processing technologies
  • The route to digital: the rise of digital therapeutics, and the new associated product landscape
  • Post-marketing safety reporting

BOOK YOUR SEAT NOW

Bastiaan De Leeuw, NL

Head of Business Development

Cambridge Design Partnership

Bastiaan De Leeuw has been active in the field of drug delivery for the last 20 years. He has led projects covering dry-powder formulation development, inhaler design and development, and auto-injector design and development, as well as the associated stages of clinical and regulatory evaluations. In addition, he led the initial clinical evaluation of urologic diagnostic tests at NovioGendix (now MDxHealth) and has worked at Focus Inhalation, Akela Pharma, Oval Medical, and Bespak. Bastiaan has a degree in biopharmaceutical sciences, focussing on polymeric drug delivery systems for the formulation of proteins and peptides. His research combined pharmaceutical technology and pharmacology in industry-sponsored projects. 

Ian Thompson, CH

Vice President Business Development, Delivery Systems med AG

Ypsomed AG

Ian Thompson has been with Ypsomed AG, formerly Disetronic AG, since 1995 in a number of roles, including key account management and business development working with pharma companies to develop and bring to market innovative self-injection systems. He studied biochemistry and biotechnology in the UK from 1979-83, working initially in commercial roles for fermentation technology. He has worked in medical device companies since moving to Switzerland in 1990. Since 2003, his main focus has been business development and new product innovation leading to the successful development and launch of a range of new pen and autoinjector custom products for Ypsomed Delivery Systems. Ypsomed Delivery Systems continues to focus on the development and manufacturing of next-generation pen, autoinjector, and wearable injector technologies.

Shruthi Vidyasagar, UK

Device Development Technologist

GSK

Shruthi is a Device Lead at GSK (Ware, UK) managing late-stage parenteral projects. Prior to GSK, she worked at Pfizer in North Chicago on differentiated drug delivery systems. She has device development and regulatory experience across multiple platforms - combination products, electromechanical devices and consumable products.

Her recent focus has been on parenteral combination products- syringes, injectors, closed transfer devices, supporting all activities from development to launch.

Shruthi holds a BE in Electrical Engineering (VTU, India) and an MS in Biomedical Engineering (University of Michigan, Ann Arbor)

Mark A. Chipperfield, UK

Company Director & Principal Consultant

Corvus Device Consultancy

Mark A. Chipperfield spent 20 years working within large pharma (GSK, Sanofi Aventis, Novartis, Roche) in the field of drug delivery devices and special purpose packaging. Throughout his career, he has been heavily involved in the development of combination products in several forms: solution/suspension inhalers, multi-dose disposable and reusable dry powder inhalers, convenience kits, pen-injectors, auto-injectors, dispensers and special purpose applicators. Since 2015, he has been an independent consultant supporting pharma companies, suppliers and device innovators across the globe to develop, launch, and maintain their products.

Tiffany Kay McIntire, CH

Senior Human Factors Enginee

Roche

Tiffany McIntire has been working as a human factors engineer for five years, developing delivery systems and labelling strategies in the pharmaceutical industry. After her studies in industrial/organisational psychology, she started her career at Lilly, where she worked on a range of combination products including dial-and-dose injectors for insulin, autoinjectors, pre-filled syringes, digital products and an emergency inhalation device. After working at Lilly, she jumped across the pond to Germany, joining a recently established device group within Boehringer Ingelheim. While there she worked to deepen the team’s knowledge of HF and improve their quality management system and vendor management. At the beginning of August, she joined the Roche HF team in Basel, Switzerland, to work with the team there generating external, scientific publications as well as guiding the team towards best practices in HF.

Mike Tate, DE

Human Factors Manager Pharmaceutical Dev. Biologicals

Boehringer Ingelheim Pharma GmbH & Co. KG

Mike has been in Human Factors for over 20 years. He initially worked for Johnson and Johnson in the area of diabetes and blood glucose meters. After this, he was Human Factors Manager for Teva Pharmaceuticals before joining Boehringer Ingelheim as Human Factors Engineer. During this time, he has been responsible for introducing processes and procedures and interpreting HF regulatory guidance and standards for combination products. This has included packaging and labeling for which there is an increased focus in terms of safety and efficacy. 

Dr. Clemens Guenther, DE

Director of Nonclinical Safety CC

Bayer AG

Dr. Clemens Günther received his diploma in biology and doctorate for natural sciences from the Free University, Berlin-Germany. From 1990 to 2006 he started his professional career at Schering AG, Berlin-Germany. From 2007 to 2013, Dr. Clemens Günther was Director and Head of Global Preclinical Development at Intendis GmbH, branded later-on as Bayer Dermatology. In this position, he was responsible for Nonclinical Safety for the marketed product portfolio of Bayer Dermatology as well as the global preclinical development strat­egy including human DMPK for development and life cycle management projects. After integration of Intendis into Bayer in 2013, he became Director Nonclinical Safety Consumer Care within the Division of Bayer Pharmaceuticals. Meanwhile Dr. Clemens Günther has gained about 30 years of experience in drug development. He has been involved in nonclinical development and regulatory toxicology of small molecules, biologics, medical devices and drug device combination products.

Dr. Daniel Latham, CH

Head Device Development & LCM

Novartis

Daniel Latham is the Head of Device Development & LCM,  where he leads an organisation of around 120 associates responsible for the development and life cycle management of delivery systems of drug/device combinations for both new biologic entities, biosimilars, and new chemical entities. Over the past 11 years at Novartis, he has overseen significant device and primary packaging developments and launches and has significantly supported the growth of device development and drug/device interaction within the organisation. Prior to Novartis, he worked in a variety of roles in consumer health­care, focusing on the development of OTC medicines, transdermal patches, and medical devices. He has a Ph.D. in controlled drug delivery from Queen Mary, Uni­versity of London and a bachelor’s degree and master’s degrees in engineering from the University of Sheffield.

Cedric Gysel, CH

Manager, Health Care Solutions Design

Johnson & Johnson

Cedric Gysel is a healthcare solutions manager for Johnson  &Johnson Design, driving human-centred solutions for patients and customers of Janssen. He has more than 12 years of experience with the development and design of devices and combination products. He holds a bachelor’s in pharmaceutical technology from the University of Basel and a master’s in medical device technology from the University of Applied Science in Bern and Stanford University with a specialisation in human-centred design.

Dr. Bassil Akra, DE

CEO

QUNIQUE GmbH

Dr. Bassil Akra is CEO and one of the owners of the QUNIQUE GmbH, a medical device and in-vitro diagnostic consultancy company, located in Germany and Switzerland. He spent the last decade as a subject matter expert at the biggest notified body in Europe and represented locally and the globally the notified body association in the various European discussion. Dr. Akra was the Vice President for strategic business development at the Global Medical Health Services of TÜV SÜD Product Service GmbH in Germany. He has long experience in leadership, business management, research, development, quality management and regulatory approval of medical devices, combination devices and ATMP products. Dr. Akra played an essential role during the implementation of the medical device regulation (MDR 2017/745) in Europe and was involved in the drafting of the several European guidance documents (e.g. MEDDEV, MDCG, etc.). He spent the last years of his career at TÜV SÜD training and educating the various stakeholders on the EU Legislations (e.g. MDD/AIMDD, MDR and IVDR) and their impact on the EU healthcare system.

Bastiaan De Leeuw, NL

Head of Business Development

Cambridge Design Partnership

Ian Thompson, CH

Vice President Business Development, Delivery Systems med AG

Ypsomed AG

Shruthi Vidyasagar, UK

Device Development Technologist

GSK

Mark A. Chipperfield, UK

Company Director & Principal Consultant

Corvus Device Consultancy

Tiffany Kay McIntire, CH

Senior Human Factors Enginee

Roche

Mike Tate, DE

Human Factors Manager Pharmaceutical Dev. Biologicals

Boehringer Ingelheim Pharma GmbH & Co. KG

Dr. Clemens Guenther, DE

Director of Nonclinical Safety CC

Bayer AG

Dr. Daniel Latham, CH

Head Device Development & LCM

Novartis

Cedric Gysel, CH

Manager, Health Care Solutions Design

Johnson & Johnson

Dr. Bassil Akra, DE

CEO

QUNIQUE GmbH

What our
participants
are saying

"I had a great time and learned a few things! Thanks for putting everything together!"

 

 

 

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Tiffany McIntire

Roche

"Thanks for the opportunity; Camilla Damgaard-Sørensen and I really enjoyed meeting all who attended, and hearing from the other presenters."

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Mark Guarraia

Novo Nordisk

"I am very honoured to be able to chair the 5th Anniversary edition of #VLPFS on behalf of Cambridge Design Partnership. Great to see so many attendees and their enthusiasm this morning at the speed networking already. Looking forward to a great 2 days."

 

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Bastiaan deLeeuw

Cambridge Design Partnership