Getting ready for IVDR
Panel discussion to help you develop an action plan
Originally aired 04 March 2021
While the pandemic has changed and continues to change operations in many molecular diagnostics manufacturers and clinical laboratories, the time is fast approaching when these manufacturers and laboratories will also need to comply with the In Vitro Diagnostic Regulation (IVDR). An early start is advised given the expected pressure on notified bodies leading up to May 2022. However, for many, IVDR raises more questions than answers. Do you know what you need to do to get ready for IVDR?
The second in a series of webinars to help you prepare for IVDR, this webinar will help you draw up an action plan by bringing you a panel discussion and Q&A by three leaders in the field who will share with you their tips on ‘Getting Ready for IVDR’.
Head of In Vitro Diagnostics & Principal Consultant, Qserve Group
Sue leads Qserve’s IVD service and has over 30 years’ experience in the Medical Device and IVD industries including extensive notified body experience. She has worked for several IVD companies ranging from start up to large multinationals, where she has held positions in R&D, manufacturing and quality assurance. Sue worked for 3 notified bodies establishing two from scratch. Sue chaired the European IVD Notified Body Working Group coordinating the notified body responses to the regulations. Sue also participated in the Commission IVD Technical Work Group for many years. She is an experienced trainer on a variety of IVD topics.
Founding partner, Axon Lawyers
Erik Vollebregt, LLM, is a founding partner of the life sciences niche firm Axon Lawyers in Amsterdam. He has more than 20 years of legal and regulatory experience in the EU and Dutch national life sciences regulation. He specialises in regulatory and legal advice, contracts, mergers and acquisition work, and litigation in the life sciences sector. Erik is an active contributor to development of EU and Dutch law in the life sciences field through national and international trade associations and advisory committees. He has degrees in Dutch law from Groningen (Netherlands) University and in European law from Stockholm (Sweden) University.
Global Director – IVD Focus Team, TÜV SÜD
Dr Julien Senac is currently Global Director of the IVD Focus Team at TÜV SÜD, overlooking the development of IVD field and in particular IVDR. Prior to this, he has many years of experience with a certification body, where he participated in the preparation of IVDR designation, and performed Design Dossier assessment of in vitro diagnostic devices. Dr Senac has a PhD in Molecular and Human Genetics from Baylor College of Medicine (Houston, TX) and more than 10 years of experience in biomedical research. He worked in top research/medical institutions in the United States such as Mayo Clinic and the National Institutes of Health. Dr Senac has also participated to the development of multiple biotech start-up companies in oncology and gene therapy.