RAPS will hold its inaugural RAPS Regulatory Conference – Europe 2019 in Brussels, 13–14 May. It comes as the European regulatory environment for medicines, medical devices and in vitro diagnostics (IVDs) is undergoing major changes, and both regulators and the regulated companies making life-saving and life-sustaining medical products face myriad uncertainties.
The EU’s new Medical Device Regulation (MDR) is set to take effect next year. A new In Vitro Diagnostic Regulation (IVDR) is not far behind, becoming law in 2022. Recent progress has been made toward implementation of the new Clinical Trials Regulation (CTR), which has been delayed by technical issues, but could be ready to go next year as well. 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.
“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. “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.”
The conference agenda is available on the conference website and will be regularly updated as additional speakers are confirmed. The event will take place at the Radisson Blu, Brussels. For those who need even more in-depth guidance on MDR and IVDR, two workshops will be held immediately following the main conference: ‘Transitioning to the EU MDR and Managing Legacy Devices’ and ‘The New EU IVDR Regulatory Paradigm.’
“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.”
The new Europe-based conference will build on RAPS’ track record of successful events, its growing European membership and its relationships with the world’s top regulatory experts.
“This conference will bring together regulatory professionals, industry leaders, regulators and other stakeholders to share information, ideas and insight,” said the committee’s other 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. “With so much about implementation of the new regulations not yet known and so much that is still subject to change, 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.”
For more information or to register for the RAPS Regulatory Conference – Europe 2019, click here