The new Europe-based conference plans to build on The Regulatory Affairs Professionals Society’s (RAPS) track record of successful events at a time where there are many changes within the European regulatory environment.
RAPS will hold its inaugural RAPS Regulatory Conference – Europe 2019 at the Radisson Blu in Brussels on the 13th to the 14th May 2019.
Its European conference is to be held amongst the sweeping changes the European regulatory environment for medical products currently faces and hopes to bring together a wide range of people such as; regulatory professionals, industry leaders, regulators and other stakeholders to share information, ideas and insight on the changing European regulatory environment.
Both regulators and companies across the sector are facing a large range of uncertainties as a result of the new laws affecting the medicines, medical devices and In Vitro Diagnostics (IVDs) sectors. Additionally, little is known about the two entities’ post-Brexit relationship. The new EU laws include:
- The new Medical Device Regulation (MDR) – 2020
- New In Vitro Diagnostic Regulation (IVDR) – 2022
- Clinical Trials Regulation (CTR) - delayed by technical issues, but anticipated to be ready in 2020
RAPS executive director Paul Brooks said, “I don’t know if there have ever been so many unanswered questions facing the makers of medicines and medical technology serving Europe, and the patients and healthcare providers who rely on them.
“Regulatory professionals have to be experts at dealing with uncertainty and planning for contingencies. Those who work in Europe or whose scope of work includes products developed or marketed in Europe are really being challenged right now. If there were ever a time this conference is needed, it’s now.”
It is anticipated that more than 50 leaders from the healthcare products sector will share their perspectives at the conference, including representatives from the European Medicines Agency (EMA), European Commission (invited), several EU competent authorities, leading notified bodies and many other industry/sector experts.
“We designed a conference for European regulatory professionals by European regulatory professionals,” said conference planning committee co-chair and RAPS president-elect, Gert Bos, who is executive director and partner with Qserve Group in the Netherlands. “There is a real need for a European event devoted entirely to regulatory issues affecting both medicines and medical devices and technology. RAPS is stepping in, with advice, guidance and active participation from our European members and volunteers, to fill that need.”
Fellow committee co-chair, Sabina L. Hoekstra-van den Bosch, a scientific staff member for the central committee on research involving human subjects in The Hague, the Netherlands added: “With so much about implementation of the new regulations yet to be done and so much that might still evolve, we can’t offer all the answers, but we can promise attendees will have access to leading experts and the collective knowledge and experience of the European regulatory community.”
The conference agenda is available on the conference website and will be updated as additional speakers are confirmed.
Following the conference there will be two workshops taking place titled, ‘transitioning to the EU MDR and managing legacy devices’ and ‘the new EU IVDR regulatory paradigm.’ These will aim to provide a more in-depth guidance on MDR and IVDR,