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REC Webcast: Supply chain management - latest developments from regulatory point of view

1.0
RAC Credits
Europe, Virtual Programs
Tuesday, 09 November 2021 (4:30 PM) - Tuesday, 09 November 2021 (5:45 PM) Central European Time (CET)

Description

Both in the pharmaceutical as in the medical device industry, regulatory requirements are increasing. In this webinar, the latest requirements towards the supply chain for contract manufacturing organizations (CMO’s) or critical subcontractors (CSC’s) are being discussed. What mean elements must be covered by quality agreements, specifically what is newly needed the last years? What are challenges the industry faces and how has Covid impacted the supply of products from these CMO’s/CSC’s? In this webcast experts from both pharma and MedTech industries will provide the latest updates from a European perspective.

A Q&A session will be provided at the end of the sessions, where questions in the chat will be discussed.

Learning Level: Intermediate & Advanced

Intermediate: Content is designed based upon the assumption that individuals have basic knowledge of the topic(s) and/or demonstrated competence related to the topic(s). Higher-level concepts are introduced during lectures; exercises requiring synthesis and/or application of concepts are incorporated into the activity.

Advanced: Content is designed for individuals who are well-versed in most, if not all, concepts associated with the topic(s). Activities place a high concentration on analysis and application of concepts or demonstration of competencies through exercises such as case studies, scenario building, and group projects. A high level of participation is expected from each attendee.

Learning Objectives:

This event is brought to you by the RAPS European Council (REC) to encourage knowledge sharing and community development. RAC holders may claim 1.0 RAC recertification credit.

This webcast is available to global regulatory professionals.

Pricing Amounts and Deadlines

Event Date: Tuesday, 9 November 16:30-17:45 CET 
Register By: 8 November, 2021
Member: € 10
Nonmember: € 25

Speakers


Erik Vollebregt, Partner, Axon Lawyers the Netherlands
Erik specialises in EU and national legal and regulatory issues relating to medical devices, including eHealth, mHealth, software, AI and protection of personal data. He is an expert in life sciences regulation at EU and Dutch level, with a focus on contracts, regulatory litigation against competent authorities and M&A. Erik was initially trained as intellectual property and competition lawyer, starting his career at the Directorate-General for Competition of the European Commission. He subsequently gained experience in contentious matters, commercial contracts, and transactional work at three large international law firms.

He actively contributes to law and policy development at national and EU level via membership of specialized committees at branch associations and the European Commission. Erik also works as arbitrator in medical devices related disputes and is regularly retained as expert witness in foreign litigation.

Erik is author of the acclaimed Medicaldeviceslegal.com blog and The Enriched MDR and IVDR handbook.


Jörg von Manger-Koenig, Attorney at Law, of Counsel, Kellerhals Carrard
Jörg von Manger-Koenig brings nearly 30 years of experience in consulting and management in the pharmaceutical, biotech and medical devices industries as General Counsel / Lawyer and Head of Regulatory Affairs and Quality Management to his consultancy activities. His practice focuses on legal, compliance, regulatory affairs, quality and general management issues with a focus on this industrial sector. In his many years of corporate practice, he was globally responsible for Legal / Intellectual Property, Compliance, Regulatory Affairs, Quality Management and Human Resources, among others at Roche Vitamins, Berna Biotech, most recently as the EVP Legal and Compliance / Group General Counsel of Nobel Biocare and VP Regulatory Affairs / Quality Management of the Danaher Dental Platform (now Envista Holdings).

Jörg von Manger-Koenig combines management and industrial experience with legal and regulatory expertise. He is a Counsel with Kellerhals Carrard, one of the leading Swiss law firms and member of its Life Sciences, Start-up and Corporate Law Practices. He also owns and operates his own consultancy that focusses on management challenges in the life sciences sector. He has recently commented on the most recent changes in the Swiss  Therapeutic Products and Medical Devices Law, which both are highly influenced by the relevant European regulation.


Robert van Boxtel, Principal Consultant, Medical Device Project B.V.
Robert van Boxtel is Principal Consultant and management team member at Medical Device Project B.V. in the Netherlands. For more then 10 years, he supports the medical device industry with QA and RA related consultancy, focusing on the EU and USA. Additionally, he provides training to the industry, Notified Bodies and Competent Authorities on EU MDR, ISO 13485, Risk Management, auditing etc. He is hired by the Dutch Standards Institute (Royal NEN), as SME for training on ISO 13485 and MDD/MDR. Furthermore, he participates in TC210 discussions on quality management systems, risk management, PMS and is member of the Dutch horizontal standards committee. Robert is Board Member of both the RAPS Netherlands Chapter and the RAPS European Council. Before joining Medical Device Project B.V., he worked at KEMA Quality Notified Body (now Dekra Certification) and in the medical device industry in several roles in design and production, both in the EU and the USA. As a result he has over 25 years of experience in the medical device industry.

Looking for More Euro-Centric Regulatory Content and Professional Development?

Take a deeper dive into some of the most pressing issues impacting our community today—including IVDR, Post-Market Surveillance in Europe, Design Controls and Data Management. Explore our up-coming European workshops produced in collaboration with the RAPS European Council (REC). Learn more and register.

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How Do Webcasts Work?

For the best webcast experience, please use the Google Chrome browser. RAPS webcasts are also mobile- and tablet-accessible for your convenience. Registrants will receive instructions on how to log in 24 hours before the start of the webcast. A Q&A portion with the speakers will follow the presentations, were selected questions posed through the chat will be discussed and answered.