Within the next few years, the Medical Device industry will need to adapt to the Medical Device Regulations (MDR). The transition period to MDR began in 2017 and completed by 2025. These regulations have implications for Device Manufacturers, Notified Bodies, Competent Authorities as well as Ethic Committees.
Two key changes, execution of clinical trials and data submission requirements, if not properly planned for and dealt with, impose serious risks for business continuity.
During our webinar, we will explain what new MDR requirements mean for Clinical Trial setup and execution. We will also dive into Data and Submission requirements relating to UDI and labeling and provide you with valuable insights on how to best prepare and allow you to understand what you are required to do as a company to ensure compliance.
We will address practical questions you might have concerning your Clinical Trials, data submissions, and labeling, including:
- Is my current trial setup sufficient to meet upcoming MDR requirements?
- What is UDI and what do I to do about it?
- How does this impact my labeling activities?
Professor in Clinical Pharmacology at the University of Ghent
Professor Pieterse studied Pharmacology at the Free University in Amsterdam. In 1977, he joined Boehringer Ingelheim and held functions in Research and Development, including, Clinical Research Manager for clinical pharmacology and International Medical Project leader for a cardiovascular research compound and Associate head of the Medical department.
In 1984, Professor Pieterse started working for Rhone-Poulenc as Medical Director. In 1988 he changed to Ovabloc Europe and took responsibility for international registration and research as Director of Regulatory Affairs and Technical/ Clinical Research. Since 1991, he founded the Consultancy and Interim Management Agency PROFESS Medical Consultancy B.V. and assists now several major companies in the healthcare industry with both regulatory and quality assurance issues, GCP clinical development and training. In November 1996, Professor Pieterse became a certified ISO 9000 Lead Auditor IRCA no. AO11064.
MSc. Rens van den Boomen
Associate Director Iperion Life Sciences Consultancy
With more than 14 years of experience within the Life Sciences industry, Rens has a proven record of successfully managing complex projects and programs within regulatory affairs, drug safety, medical affairs, quality and compliance, manufacturing and supply chain. He has undertaken, led and managed a diverse variety of global strategic, operational and implementation engagements Rens is a subject matter expert in regulatory Information management, data governance and structured product Information (IDMP)