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6th Annual Pre-Filled Syringes & Injectables Online Summit

  • 26th – 27th November 2020
  • Zoom flag Zoom
  • ONLINE

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 Pre-Filled Syringes & Injectables Event

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 digitalization, 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 specializing 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
  • Standardization Science
  • Smart Devices
  • Sterile Products
  • Vaccines
  • Validation

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

Bastiaan De Leeuw, NL

Director - Business Development Biomaterials

Corbion

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, Bespak, and most recently at Cambridge Design Partnership. Bastiaan holds a degree in biopharmaceutical sciences from Leiden University in The Netherlands. As of November 2020, he has joined Corbion as Director - Business Development Biomaterials.

Jakob Lange, CH

Senior Director, Delivery Systems

Ypsomed AG

Jakob Lange is an engineer and materials scientist by training with a master’s degree in chemical engineering from the Royal Institute of Technology in Stockholm, Sweden, and a PhD in polymer science from the Swiss Federal Institute of Technology in Lausanne, Switzerland. He has written and published more than 30 peer-reviewed papers on medical devices, packaging materials and polymers, and is a regular contributor to technical and scientific conferences. Jakob started his professional career as a research scientist in packaging R&D with Nestlé at the Nestlé Research Centre in Lausanne, Switzerland. He then worked in R&D management with GE Healthcare Biosciences in Uppsala, Sweden, before joining Ypsomed in Burgdorf in 2006. With Ypsomed he has held different positions within marketing and sales as well as in R&D project management. Currently he is a senior director of delivery systems, overseeing two teams of product managers, one managing Ypsomed’s autoinjector platforms and the other focussing on customer relationships for device development projects and marketed device products.

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, Senior Expert Nonclinical Safety

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.

Katharina Golly, CH

Device Manager, Packaging Technology

Novartis

Katharina Golly started her professional career as a Development Engineer at Schott in 2010. She was responsible for the design development, verification, and industrialization of silicone-based coatings for both glass and COC pre-filled syringes. In 2015 she joined Novartis as a primary packaging expert and supported ophthalmic PFS projects prior to becoming the Delivery System's technical lead for Vials& kits. Katharina holds a Medical Engineering degree, Dipl. Ing (FH), of the University of Applied Sciences Ulm, Germany.

Eva Conraths, CH

Device Engineer, Packaging Technology

Novartis

Eva Conraths has been working as a technical expert in the area of primary packaging and fluid path components for 3.5 years at Novartis supporting vial kit and pre-filled syringe projects for parenteral and ophthalmic applications. She graduated from the Karlsruhe Institute of Technology with a B.Sc. in Bioengineering and from the University of Stuttgart with a M.Sc. in Medical Engineering. During her studies, she already gained various industrial expertise in drug delivery device development.

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.

Julia Frese, DE

Department Manager Centre of Combination Products

TÜV SÜD Product Service GmbH

Julia Frese is a biomedical engineer with a Master's degree in business administration. Julia gained experience in the development, regulatory approval of combination devices, and ATMP products. She was further involved in the development of standards for ATMP products. Currently, Julia Frese is heading the division of Medical and Health Services at TÜV SÜD Japan and is responsible for the development of article 117 service within the organization. She is further co-chair of the Team NB working group for article 117.

Bastiaan De Leeuw, NL

Director - Business Development Biomaterials

Corbion

Jakob Lange, CH

Senior Director, Delivery Systems

Ypsomed AG

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, Senior Expert Nonclinical Safety

Bayer AG

Katharina Golly, CH

Device Manager, Packaging Technology

Novartis

Eva Conraths, CH

Device Engineer, Packaging Technology

Novartis

Cedric Gysel, CH

Manager, Health Care Solutions Design

Johnson & Johnson

Dr. Bassil Akra, DE

CEO

QUNIQUE GmbH

Julia Frese, DE

Department Manager Centre of Combination Products

TÜV SÜD Product Service GmbH

BROCHURE

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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