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18 Oct 2017

New European Council of regulatory professionals set to shape and support the profession

The RAPS European Council (REC) from left to right: Lena Cordie, Pallavi Trivedi, Peter Schrutka-Rechtenstamm, Philippe Auclair, Sabina Hoekstra, Paul Brooks, Andreas Wiegand, Gert Bos, Benjamin Frisch, Don Boyer, Jennifer Neff, Rainer Voelksen, Michael Maier, Anja Wiersma.

New European Council will support RAPS’ growing member base and volunteer network across Europe to ensure compliance with global regulations and to drive regulatory excellence

The Regulatory Affairs Professionals Society (RAPS) is stepping up its presence in Europe and supporting its European expansion with the launch of its first ever RAPS European Council (REC).

Following the announcement that the society plans to invest more than 2 million euro over the next 3 years to implement its growth plan in Europe, the new European Council will support RAPS’ growing member base and volunteer network across Europe with the information and education they need not only to ensure compliance with global regulations, but also to drive regulatory excellence and advance public health.

Chaired by Sabina Hoekstra-van Bosch, with Philippe Auclair and Rainer Voelksen as co-Chairs, the REC is a collaboration of senior regulatory professionals from Belgium, Germany, Spain, Switzerland and the UK to support those working in regulatory roles in the life sciences sectors in Europe. By steering RAPS’ EU strategic directions, they represent RAPS and its members with EU and national authorities and provide in-depth understanding of the global and local context of regulations across the medical device, pharmaceutical and biotech markets.

In addition to providing strategic input, they are also responsible at an operational level, by expanding and supporting RAPS’ European activities. This includes the assigning of ‘flexible’ sub committees under the umbrella of the REC who are responsible for coordinating educational and informative roadshows and workshops for RAPS’ members on the latest regulatory challenges.

Alongside the newly formed REC, RAPS has also recently announced that its Swiss Chapter is the first ever to complete the official registration process to become a not-for-profit association under Swiss law. Michael Maier, Vice President of the Swiss Chapter and REC member comments: “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.”

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 20% to nearly 2,000 members across 29 countries.

“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 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 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.”

RAPS’ plans for the rest of 2017 in Europe include workshops specifically focusing on eCTD on 6–7 November in Frankfurt, Germany and 510(k) on 13-14 November in Vienna, Austria, as well as a selection of roadshows in Maidenhead, UK on 28 November, in Hanover, Germany on 30 November and in Ulm, Germany on 4 December.

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