About the event
The purpose of this session is to allow participants in an informal setting to ask questions specifically regarding any aspects of EU MDR within a 1 hour session. You can expect:
- Three different Medical Device experts presenting on aspects of MDR
- Shared knowledge from experts with varying backgrounds in regulatory and legal
- Update on the status of MDR in the UK and EU.
To help us manage the flow of questions throughout this session, we would like to request you to send any questions you have on this topic ahead of the session to membership@topra.org
Date: 30 April 2020 | Time: 13:00–14:00 BST (GMT+1)
Topics and speakers
Topic: The EU / UK regulatory aspects of the new MDR
Speakers: Louise Place and Richard A. Vincins
Louise Place heads up the Regulatory team at Cambridge Design Partnership, a full service Medical consultancy firm. She has nearly 15 years’ experience in Drug delivery, Medical device and In vitro diagnostic development, focusing on FDA device technical management for combination product submissions. CE marking for medical device and EMA medical product submissions. In her current role she is responsible for developing Regulatory strategy and Regulatory Intelligence as well as providing Regulatory consultation and remediation services.
Richard A. Vincins is part of Oriel STAT A MATRIX team as Vice President Global Regulatory Affairs responsible for regulatory affairs and quality activities. In this role he is responsible for regulatory strategies, regulatory submissions, remediation of technical documentation, conducting quality system audits, and providing regulatory expertise in national and international regulations. He brings over 25 years of experience in the medical industry including worldwide regulatory compliance efforts for medical device, IVD, and pharmaceutical companies.
Topic: The new MDR from an EU legal perspective
Speaker: Dr. Cord WilIhöft LL.M.
Dr. Cord WilIhöft LL.M. advises medical technology and pharmaceutical companies in regulatory matters, healthcare compliance and market access.
Cord has particular expertise in regulatory matters such as marketing authorisations, CE marking, distribution (agreements and GDP), placing medicinal products and medical devices on the market, compassionate use, named patient programs, wholesaler license and clinical trials. His regulatory expertise includes also legal advice and/or internal/external training on “Regulation (EU) 2017/745 readiness” for companies.
He further advises companies in unfair competition law, including advertisement of medicinal products and medical devices, as well as collaboration between the healthcare industry with healthcare professionals and patient organisations. Further, he has extensive experiences in advising companies in all matters concerning pricing and reimbursement in the out-patient and hospital sector (ie, AMNOG, NUB proceedings, various health technology assessment procedures for medical devices, rebates, reference pricing, DRGs and pre-market access strategies).
Panelists: TOPRA In England and Wales Chair - Kathleen Adom, Regulatory Affairs Manager from Allergan Ltd - and Deputy Chair - Lucy Pitcher, Senior Consultant at Syneos Health.
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