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When:  3 December 2019
Where:  DoubleTree By Hilton Amsterdam Centraal Station, Oosterdoksstraat 4, Amsterdam 1011 DK, Netherlands
Time:  08:30 – 17:00

Workshop overview

The Medical Device Regulation MDR legislation will come into full effect in May 2020, requiring new procedures and involving notified bodies in assessment of device constituents of medicinal products.

Following a successful joint meeting with RAPS last November, which considered the impact of the MDR on both drug-device and device-drug combination products, and the TOPRA Symposium Human Medicines/Medical Devices DDC Session, this meeting will focus on the practical implementation of MDR Article 117 and EMA guidance, including:

• discussion of EMA Q&A and high priority comments on the draft DDC quality guideline
• new interactions with Notified Bodies, with representatives from TEAM-NB
• content of the Notified Body Opinion (NBOp)
• case studies of challenging areas including platform technologies and substantial changes
• future steps in preparation for MAA submissions after May 2020

Benefits to delegates

• Hear from key stakeholders on the next steps in the implementation of guidance for drug-device combinations.
• Discuss the challenges and solutions for the future of drug-device combination products.
• An opportunity to ask questions and have an open discussion with speakers and delegates.
• Understand the complexities and collaborative efforts ongoing to implement the new ways of working as efficiently as possible.
• Build a network to support the rest of your career.

To learn more about why Continuing Professional Development is important, visit our Lifelong Learning page.

Programme

You can download the current programme here.

Speakers and moderators

Elizabeth Baker Group Manager, Licensing Division MHRA

Tim Chesworth Senior Director Regulatory Affairs - Medical Devices & Combination Products AstraZeneca

Mark A Chipperfield Principal Consultant and Company Director Corvus Device

Julia Frese Co-chair Article 117 Taskforce, Team-NB Department Manager, Centre of Combination Products, TÜV SÜD Product Service GmbH

Maren von Fritschen Director, Regulatory Affairs EUCOPE

Janine Jamieson EU Editor International Pharmaceutical Quality Publications

Margareth Jorvid CEO, Regulatory Affairs and Quality Assurance Methra Uppsala

Bjørg Kaae Hunter Regulatory Manager, Devices GSK

Petra van Leeuwen Co-chair Article 117 Taskforce, Team-NB Project manager, DEKRA Certification BV

Andrew Lennard Reg Affairs CMC, External Engagement & Policy Amgen

Amanda Matthews Senior Director, Regulatory CMC for Combination Products & Medical Devices Pfizer

Abigail Moran Rapporteur for the EMA QWP/BWP Guideline on Quality requirements of drug-device combination products and Senior Pharmaceutical Assessor, MHRA

Ilona Reischl BWP representative of the QWP/BWP Guideline on Quality requirements of drug-device combination products, EMA CAT Vice-Chair, and Head of Clinical Trials, Federal Office for Safety in Health Care (BASG) - Austria

Jonathan Sutch Member, Article 117 Taskforce, Team-NB Drug-Device Combination Expert, BSI

Suitable For

• Professionals with an understanding of drug-device combination products
• Professionals currently working with medicinal products using a delivery device
• Professionals intending to incorporate drug-device combinations or digital technologies in the future

Pricing  

Suitable For

• Professionals with an understanding of drug-device combination products
• Professionals currently working with medicinal products using a delivery device
• Professionals intending to incorporate drug-device combinations or digital technologies in the future.

Pricing  

Terms and conditions

• The registration fee does not include accommodation
• Refreshments and lunch are included in the registration fee

By booking a place on this course you are agreeing to our training terms and conditions