Experts from European Commission set to advise EU regulatory affairs professionals on new regulation
The Regulatory Affairs Professionals Society (RAPS) has announced its full line-up of speakers for the latest workshop in its spring programme focused on compliance with the new Medical Device Regulation (MDR) and In Vitro Diagnostics Regulation (IVDR).
The Transitioning to the new EU MDR and IVDR workshop takes place 16-17 May in Brussels and brings together medical device experts, including regulatory body representatives, to explore the challenges of the impending regulations.
Erik Hansson, deputy head of unit, DG Health and Consumer Protection at the European Commission and Niall MacAleenan, deputy director, head of medical devices dept from the Health Product Regulatory Authority (HPRA), will be among the speakers at the two-day interactive workshop.
These keynote speakers will provide timely progress updates on the Competent Authorities for Medical Devices (CAMD) MDR/IVDR Roadmap, as the organisation meets in Brussels two days prior to the event.
Commenting on the workshop, Paul Brooks, executive director, RAPS said: “The introduction of the MDR and IVDR in Europe presents a huge challenge to manufacturers and should be high on the industry’s agenda as we move towards the regulatory deadlines.
“As the EU experiences such a busy transitional regulatory landscape, it’s becoming more and more important for RAPS to support its members in Europe to ensure that they are able to stay up to date on regulatory developments that the market is currently experiencing and remain ahead in their regulatory responsibilities.”
Other prominent speakers include representatives from leading Noti?ed Bodies and industry implementation experts including Salvatore Scalzo, policy and legal officer, European Commission and Nick Baker, Fellow of the Institute of Biomedical Sciences (FIBMS) and head of IVD Notified Bodies LRQA.
Attendees will have ample opportunity to hear from and engage with expert panels of regulatory professionals actively working on the practical application of the new regulatory requirements. The workshop will include sessions on managing legacy devices, changes introduced by the new General Safety and Performance Requirements, transition strategies and much more.
RAPS continues to boast the largest global membership for regulatory professionals in the healthcare, medical device, biologic and pharmaceutical sectors. Its European member base has grown by approximately 30 per cent in only 12 months which now results in a global network of over 16,000 members across more than 90 countries.