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Turbulent Times In Europe: The Case For Being Pro-Active
March 3, 2021 @ 11:30 am - 1:00 pm
A Hands-On To-Do Shortlist Of Regulatory Action To Be Taken In 2021.
1.5 Hours Towards Your Continuing Education
Program Manager: Piet Lesage, Principal Consultant GB5D
Jaap Laufer MD, PharmD, Medical Director at Emergo by UL.
Ronald Baumans, Senior Consultant, Regulatory Affairs, Emergo by UL.
The interactive session will provide a much-needed prompt to action concerning EUDAMED, Clinical evidence, Post-Market Compliance, Economic Operators, care to stay within the MDD if you can, and other hot topics.
Oh yes, and then there is BREXIT and SWIXIT…
With only months away from the definitive Date of Application (DoA) for the MDR, and just a little over one year to go for the DoA of the IVDR, it is less than 5 minutes to 12 to take the necessary actions to stay or get into compliance with what arguably is one of the more complex regulations for medical devices in the world.
This lecture will provide an overview of the challenges and solutions.
*Feel free to email questions ahead of time! [email protected]
11:30 – 11:35: Quick intro OCRA, speakers
11:35 – 12:05: Dr. Jaap Laufer addresses MDR
12:05 – 12:15: Questions on MDR section
12:15 – 12:35: Mr. Ronald Bouwmans addresses Brexit and Swixit
12:35 – 12:50: Brexit, Swixit and MDR questions.
- OCRA Members: $25
- Non-Members: $100, includes 1-year OCRA membership
- Government and Student Members: $10, with student/government ID
- Non-Member Government and Student Rate: $45, includes 1-year OCRA membership
Jaap L. Laufer, MD, Ph.D. -Medical Director, EMERGO by UL. [email protected]
Dr. Jaap Laufer has over 30 years regulatory experience and specializes in implant and high-risk device and combination product submissions, FDA QSR compliance and clinical study submissions and compliance.
As Emergo’s Medical Director, he is an expert reviewer of clinical data and evidence for novel and high-risk devices. In his additional capacity as senior clinical consultant, he also peer reviews EU clinical evidence submissions and product classification and assists with Notified Body management. He has attended countless meetings with FDA and Notified Bodies.
Dr. Laufer teaches International Regulatory Affairs at the University of Southern California (USC) in Los Angeles. He is also a permanent member of the Medical Devices Coordination Group (MDCG) to the European Commission for Classification, formerly the Medical Devices Experts Group (MDEG, since 2005).
He is the founder of a small company in Switzerland that specializes in FDA compliance for non-US companies. In 1999 Dr. Laufer established the European Association of Authorized Representatives, a small but influential trade organization.
He held corporate positions in Regulatory and Clinical Affairs in Switzerland–based Lipomatrix (mammary implants), Pfizer Hospital Products Europe, and Abbott Laboratories (drugs).
Dr. Laufer holds degrees in Pharmacy and Medicine from the University of Groningen, The Netherlands. He published numerous articles in his areas of expertise. He is married and has two children who have their own families in Irvine, CA and in Tel Aviv.
Ronald Boumans – Senior Consultant, Regulatory Affairs at Emergo
Mr. Ronald Boumans has been focusing on the transition to the new Medical Devices Regulation for manufacturers of medical devices. This includes clinical strategies and notified body search. On top of that he is now involved in the effects of the United Kingdom leaving the EU, and Switzerland possibly becoming a third country for medical devices from the EU perspective. Ronald has a wide range of experience in borderline cases, where the product status is not immediately clear or where the risk class is an issue. He is also involved in sensitive market surveillance cases, where competent authorities need to be informed adequately. He represents Emergo in the Executive Board of the European Association of Authorized Representatives (EAAR) and he is delegated by EAAR to the MDR Eudamed Steering Committee and four of the seven MDR Eudamed Working Groups. Since the beginning of 2021 he is also representing Emergo in the UK Responsible Person Association (UKRPA). The UKRPA has already established a good working relationship with the MHRA.
He started working for Emergo in 2013. Since then he has worked on more than 100 projects, involving product status determination, Clinical Evaluation Report assembly, Technical Documentation assembly, training, assisting manufacturers in discussions with Competent Authorities etc. He is one of the leading authors of regulatory white papers and blogs published on the Emergo website.
Before working for Emergo Ronald was a Senior Inspector at the IGJ, the competent authority for medical devices for The Netherlands. As a senior inspector he has been involved in inspections of manufacturers of medical devices and IVD’s. He has worked on many market surveillance cases and on projects in which technical documentation of a cohort of manufacturers was linked to actual market experience in hospitals or other environments. He has represented The Netherlands in several working groups of the European Commission, like the MDEG on Borderline and Classification, the COEN working group and Eudamed. He has worked for the IGJ for more than 11 years.
Ronald compares Regulatory work with flying a plane: a good pilot can land his plane in a storm; an excellent pilot does not end up in bad weather.
OCRA Registration Instructions:
It is important that you register with the name and email address where you want the webinar information sent and with the name you want to appear on the certificate of attendance.
Certificates of attendance will be emailed within a day of the event.
Registration deadline is March 2nd. There is no same day registration.
OCRA’s non-profit Federal Tax ID# 33-0630455
For a refund, please email your cancellation request to OCRA Program Chair ([email protected]) by February 28th, 2021.
If you have any questions or require additional information, email OCRA Program Chair ([email protected]).