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RAPS/TOPRA Inter-regulatory and Stakeholder Workshop: Alignment of Global ‘Combination’ Products Regulations

RAC Credits
Wednesday, 10 June 2020 (9:00 AM) - Thursday, 11 June 2020 (5:00 PM) Eastern Time (US & Canada)

Alignment of Global Combination Products Regulations

In order to provide you a level of certainty in planning in the face of the COVID-19 situation, this event is now being delivered online as an online workshop. We are working with our instructors to ensure that the same learning objectives and quality of the education will be delivered regardless of this modification. RAPS is closely monitoring developments in the Coronavirus (COVID-19) outbreak. See our public safety page for the latest updates.

The Regulatory Affairs Professionals Society (RAPS) along with The Organisation for Professionals in Regulatory Affairs (TOPRA) are partnering for their second joint workshop. The workshop will discuss different regional approaches to combination products. By bringing together regulatory affairs professional leaders, the workshop will provide an opportunity to learn about the different global approaches to 'combination' product regulation.

Our diverse panel of speakers includes representatives of the European Medicines Agency, EU Notified Bodies, FDA officials, regulators from Health Canada, Malaysia Medical Devices Agency, Anvisa and industry experts to explore the challenges and look for commonalities in the regulation of medical products with both drug and device components.

Increasingly, medical products, including IVDs and software are being used together in new ways — we will find out how the different regulators are handling these complex combinations.

This workshop will include a review of the changes the EU Medical Device Regulation will bring for combination products and explore how a range of different topics are addressed from the perspectives of:

  • Legislative background and state-of-play guidance and interpretation
  • Device primary mode of action
  • Drug primary mode of action
  • Stakeholder discussion and conclusions

Don't miss your chance to learn about new developments first-hand from the regulators, understand how different centers interact, how good practices from both device- and drug-led combinations lead to better quality products, and have your say during this important workshop!

Registration Closes: 9 June 2020
Refund Deadline: 12 May 2020*
*Please see the cancellation policy below.

RAC Credits: 8 (Upon attending and completing the program)

Will the meeting be recorded? Yes

Registration (closes 9 June 2020
RAPS/TOPRA Members: $714
Nonmembers: $824

In order to receive your TOPRA member discount when registering for the course, please use the discount code COMBO20 during checkout.

NOTE: Advance registration is required for this workshop therefore participants are encouraged to register early. Onsite registrations are not accepted.

Program Schedule:

10 June 2020

Legislative Background and State of Play Guidance & Interpretation

  • FDA Office of Combination Products
  • Background to MDR on Device-Drug and Drug-Device Combination Products in EU
  • EU Notified Body Perspective
  • Malaysian and Asia Perspective
  • Anvisa Perspective
  • Health Canada Perspective

Device Primary Mode of Action

  • Different Definitions, Classification and Data Requirements
  • QMS as a Common Global Requirement
  • Human Factors and Usability Engineering
  • Useful Clinical Data and Real-World Evidence

11 June 2020

Mode of Action

  • Different Definitions, Classifications, and Data Requirements<
  • ICH Quality Documents as Common Approach – Convergence of Quality Approach for Both Types of Combination Products
  • Lifecycle Management – Postmarket Changes
  • Case Study: A Small Innovative Biotech Company with Breakthrough Designation Medicines Addressing Different Regional Combination Product Legislation
  • Challenges for Global Development and Registration of Novel and Innovation Combination Products at a Time of Rapidly Evolving Regulations
  • Panel Discussion

Stakeholder Discussion and Conclusions

  • Summary of Key Points
  • Speaker Panel Debate

NOTE: The agenda may vary based on changing requirements.


Gert Bos, Executive Director and Partner, Qserve Group
Janine Jamieson, EU Editor, IPQ Publications
Barr Weiner, USFDA, Office of Combination Products
Armin Ritzhaupt, Regulatory Affairs, European Medicines Agency (EMA)
Mariammah Krishnasamy, Malaysian Medical Device Authority (MDA)
Douglas Watson, Medical Devices Directorate, Health Canada
Kim Trautman, Executive Vice President, Medical Device International Services at NSF International
Manfred Maeder, Lead, ASTM 55 CP Combination Product Working Group
Susan Neadle, Johnson & Johnson
Suzette Roan, Sanofi
Lee Leichter, Consultant
Ben Stevens, Director Regulatory Affairs CMC, Alnylam Pharmaceuticals
Daniela Drago, Senior Director, US Regulatory Sciences at Biogen

Cancellation or Substitutions

RAPS reserves the right to cancel this program at its sole discretion. RAPS will not be responsible for travel or other costs incurred due to cancellation. All cancellation requests must be submitted in writing to raps@raps.org. RAPS is unable to accept cancellations by phone. Please specify the name of the person registered and event title. Due to uncertainty surrounding the COVID-19 situation’s impact on travel our standard cancellation fees will be waived. Should you need to cancel your registration, you can apply your credit to any RAPS program for the next 12 months. Substitutions may be accepted with written approval from RAPS and must be submitted to raps@raps.org. Due to uncertainty surrounding the COVID-19 situation, RAPS will allow substitutions up to the first day of the event.

Proof of Attendance

RAPS will send an electronic letter or a certificate of attendance upon request.


Call RAPS Solutions Center at +1 301.770.2920, Ext 200

Registration Form

If it is your preference, please use the Registration Form to register by mail, email or fax. To expedite your registration for mail orders, your employer must include a copy of the completed registration form. A RAPS online account will be created to complete your purchase if you are not a member or past customer.

Program Contact

Nichelle Sankey
+1 301 770 2920, Ext 291