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The Regulatory Affairs Professional Society (RAPS) has unveiled the details of its inaugural European regulatory conference, RAPS Regulatory Conference-Europe 2019.
The Regulatory Affairs Professional Society (RAPS) has unveiled the details of its inaugural European regulatory conference, RAPS Regulatory Conference-Europe 2019, which will be held at the Radisson Blu in Brussels, Belgium, May 13–14, 2019.
Bringing together regulatory professionals, industry leaders, regulators, and other stakeholders, the conference aims to provide a platform for all participants to share ideas, information, and insight on the changing European regulatory landscape. Additionally, the event coincides with the introduction of multiple new laws that affect the medicines, medical devices and in vitrodiagnostics (IVDs) sectors, including the new Medical Device Regulation (MDR)-2020, the new In Vitro Diagnostic Regulation (IVDR)-2022, and the Clinical Trials Regulation-expected to be ready in 2020. Furthermore, Brexit, which is planned to happen on Mar. 29, 2019, is also expected to significantly impact the regulatory landscape of the region.
“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,” said RAPS executive director Paul Brooks in a Mar. 6, 2019 news release. “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.”
“We designed a conference for European regulatory professionals by European regulatory professionals,” added 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.”
Fellow committee co-chair, Sabina L. Hoekstra-van den Bosch, PharmD, FRAPS, a scientific staff member for the Central Committee on Research Involving Human Subjects in The Hague, the Netherlands stated, “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.”
More than 50 thought-leaders from the healthcare products sector are scheduled to share their perspectives during the conference. These thought-leaders will include representatives from the European Medicines Agency, European Commission (invited), several EU Competent Authorities, leading notified bodies, and other industry/sector experts.
The agenda is available on RAPS’ website.