The Regulatory Affairs Professionals Society (RAPS) will hold its inaugural RAPS Regulatory Conference – Europe 2019 at the Radisson Blu in Brussels, between 13 and 14 May.

The conference will bring together regulatory professionals, industry leaders, regulators and other stakeholders to share information, ideas and insight on the changing European regulatory environment. The event comes as a host of new laws affecting the medicines, medical devices and in vitro diagnostics (IVDs) sectors are due to come into effect, with both regulators and companies across the sector facing myriad uncertainties.

On top of these pending new major regulations, the UK is just weeks away from its planned exit from the EU with no deal in place to define the two entities’ post-Brexit relationship.

“Europe’s regulatory environment for medicines and medical technology is always evolving but we are now going through a period of major transition,” said RAPS executive director Paul Brooks. “The new Medical Device and IVD Regulations, impacts on pharmaceutical manufacturers of combination products and the uncertain future of Brexit present a unique and complex set of challenges for the European life sciences sector. It is vital for all stakeholders to engage in productive and informed dialogue.”

The agenda has just been released and features representatives from the European authorities, notified bodies and trade representatives, all thought leaders and stakeholders with crucial responsibilities in the effective implementation and functioning of the changing European regulatory environment. More than 50 thought 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, PhD, FRAPS, 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.”