Stepping up to the European plate — RAPS launches European Council

The Regulatory Affairs Professionals Society (RAPS) is launching its first European Council (REC) to support its expansion and to increase its presence within the region.

This news comes after the society announced its plans to invest more than €2 million in its growth plan for Europe over the next three years. The investment will be used to support RAPS’ increasing member base and volunteer network across the continent with information and education on global regulations’ compliance.

The REC will be a collaboration of senior regulatory professionals from Belgium, Germany, Spain, Switzerland and the UK and will be chaired by Sabina Hoekstra-van Bosch, with Philippe Auclair and Rainer Voelksen as co-chairs. The members of the council will help to steer RAPS’ EU strategic directions as representatives of both the society and its members, and will provide in-depth understanding of the global and local context of regulations across the medical device, pharmaceutical and biotech markets.

Further to the strategic input, the new council will also be responsible for the expansion and support of RAPS’ European activities at an operational level. These responsibilities will include assigning ‘flexible’ sub committees who will be responsible for coordinating educational and informative roadshows and workshops for society members on the latest regulatory challenges.

“RAPS membership in Europe is growing, and these new European investments demonstrate our commitment to expanding our local level presence in important life science hubs in the region,” said RAPS executive director Paul Brooks. “Our members in Europe are extremely engaged and committed to the regulatory profession and the local regulatory community. In turn, with the creation of the REC, we are committed to understanding and supporting their needs for many years to come.”

In addition to the formation of a new European Council, RAPS has also announced that its Swiss Chapter has completed the official registration process to become a not for profit association under Swiss law. Commenting on this achievement, Michael Maier, vice president of the Swiss Chapter and REC member said: “The RAPS Chapter in Switzerland has been created to provide an in-person forum for regulatory professionals to network with peers and share insights and knowledge on the latest regulatory requirements impacting their industries.”

“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,” concluded Brooks. “In particular, changes to regulations in Europe such as the eCTD, Medical Device Regulation (MDR) and 510(k) present a huge challenge to manufacturers and should be high on the industry’s agenda as we move towards their regulatory deadlines.”