New European Council of regulatory professionals set to shape and support the profession
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.
Related News
-
News Patients vs Pharma – who will the Inflation Reduction Act affect the most?
The Inflation Reduction Act brought in by the Biden administration in 2022 aims to give better and more equitable access to healthcare in the USA. However, pharma companies are now concerned about the other potential costs of such legislation. -
News CPHI Podcast Series: What does the changing US Pharma market mean for industry and patients alike?
In this week's episode of the CPHI Podcast Series Lucy Chard, Digital Editor for CPHI Online is joined by James Manser to discuss the political and market changes in the US pharma field. -
News CPHI Barcelona Annual Report illuminates industry trends for 2024
The CPHI Annual Survey comes into it’s 7th year to report on the predicted trends for 2024. Over 250 pharma executives were asked 35 questions, with their answers informing the industry landscape for the next year, spanning all major pharma marke... -
News Which 10 drugs are open to price negotiation with Medicare in the USA?
The Centres for Medicare & Medicaid Services, under the Biden administration in the USA, has released a list of the 10 drugs that will be open to price negotiations as part of the new legislation under the Inflation Reduction Act (IRA). -
News EU Medical Devices Regulation causes unintended disappearances of medical devices for children, doctors state
Doctor groups and associations have appealed to the EU to correct the EU Medical Devices Regulation law that may cause unintended shortages of essential drug and medical devices for children and rare disease patients. -
News 10 Major Drug Approvals So Far in 2023
Last year, 37 novel drugs were approved by the FDA, this was a high number for such a category, and covered many fields including oncology, demonstrating how promising further research is, and how it is only continuing to build. To date, there are alre... -
News Detecting Alzheimer's disease with a simple lateral flow test
A novel rapid diagnostic test for early-stage Alzheimer's disease has been developed using a biomarker binder from Aptamer Group along with technology from Neuro-Bio, the neurodegenerative disease experts. -
News CPHI Podcast Series: outsourcing and manufacturing trends
Listen to the CPHI Podcast Series this June to hear Gil Roth of the PBOA speak with Digital Editor Lucy Chard about the biggest trends and topics to watch in pharma outsourcing and manufacturing at the minute.
Position your company at the heart of the global Pharma industry with a CPHI Online membership
-
Your products and solutions visible to thousands of visitors within the largest Pharma marketplace
-
Generate high-quality, engaged leads for your business, all year round
-
Promote your business as the industry’s thought-leader by hosting your reports, brochures and videos within your profile
-
Your company’s profile boosted at all participating CPHI events
-
An easy-to-use platform with a detailed dashboard showing your leads and performance