The Regulatory Affairs Professionals Society (RAPS) is stepping up its presence in Europe and expanding its European team in response to growing membership demand from those involved with the regulation of healthcare and related products.
In the last 12 months, the largest global organisation for regulatory professionals in the healthcare, medical device, biologic and pharmaceutical sectors has seen its European member base grow by approximately 19% to more than 1500 members across 29 countries.
RAPS plans to invest more than €2 million in the next 3 years, implementing a strategic growth plan in Europe that includes launching new events and resources to serve the needs of regulatory professionals in the region.
RAPS Executive Director Paul Brooks said: “Europe has a vibrant and progressive healthcare products community and many of our existing regulatory professionals are working here, so increasing our investment in Europe was a natural next step for RAPS.”
“Healthcare is a global business, and with more than 15,000 members in more than 80 countries, we are well aware of the challenges regulatory professionals face worldwide. Our own research has shown that in Europe more than 65% of professionals in the healthcare product industries have multiregional or worldwide responsibilities,” said Brooks. “RAPS is committed to understanding the specific needs of European regulatory professionals and supporting our local chapters and networks.”
The investment programme includes a substantial increase in staff resources for European members and a series of European events including a RAPS Roadshow: ‘Examining the New European Medical Device Regulations’ on 4 May in Munich and a workshop ‘EU Regulatory Essentials, Medical Device and In Vitro Diagnostics: Transitioning from Current Directives to New Regulations’ on 4 and 5 July in Brussels.
Brooks continued: “In highly regulated environments such as the pharmaceutical and medical device sectors, there is a greater need than ever for regulatory professionals to stay up to date on the latest regulatory developments. In particular, changes to medical device regulations in Europe present a huge challenge to manufacturers and should be high on the industry’s agenda as we move towards the 2020 deadline.”
In addition to in-person events, RAPS will host a four-part virtual programme in May, ‘Understanding the New EU Medical Device and IVD Regulations’ and has produced a helpful ‘interactive guide’ to the new EU Medical Device and IVD Regulations.
As part of its investment in Europe RAPS is also looking to increase awareness of its Regulatory Affairs Certification (RAC). The RAC is the only professional certification specifically for those in the healthcare product regulatory field, testing knowledge and critical thinking relating to the international practice of regulatory affairs.
Four RAC credentials are available, including one focused on European regulations. Currently, more than 4000 individuals around the world are RAC-credentialed.