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The highly-anticipated fifth edition is here! Get the must-have resource for achieving compliance with medical device regulations.
Hear from leaders around the globe as they share insights about their experiences and lessons learned throughout their certification journey.
The RAPS European Council (REC) is comprised of senior regulatory professionals from across the region that support RAPS’ growing member base and volunteer network across Europe with the information and education needed not only to ensure compliance with global regulations, but also to drive regulatory excellence and advance public health.
The REC also identifies essential initiatives for strategic focus and represents RAPS and its members with EU and national authorities—providing in-depth understanding of the global and local context of regulations across the medical device, pharmaceutical and biotech markets.
RAPS is seeking qualified individuals to serve on the REC for a 2021-2023 term.
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Susana de Azevedo Wäsch is a biotechnologist and vice president of quality management and regulatory affairs with Ypsomed AG. She has more than 18 years of experience in medical devices, pharmaceuticals and biotechnology. Wäsch is experienced in the areas of regenerative medicine, implants, drug-device combination products and infusion pumps. Prior to Ypsomed, she worked at Geistlich Pharma AG, Switzerland; Eidgenössische Technische Hochschule Zürich; Lonza Visp, Switzerland; the European Bioinformatics Institute, Cambridge, England; and the Center for Advanced Research in Biotechnology in Rockville, MD, USA. After earning her MSc at the Ecole Supérieure de Biotechnologie Strasbourg, France, she performed her dissertation at the Institute of Microbiology at the Swiss Federal Institute of Technology in Zurich, followed by further training at the Executive School of Management, Technology and Law in St. Gallen, Switzerland.
Lena Cordie-Bancroft is the Sector Lead for Medical Devices on BSI’s Knowledge Solutions division, where she is responsible for working with industry and government stakeholders to resolve issues surrounding the development and designation of medical devices standards; providing subject matter expertise and thought leadership to strengthen and promote the use of standards; and influencing the strategy of healthcare standards through innovation and collaboration with other sectors. Lena was previously president and principal consultant at Qualitas Professional Service, where she worked with medical device companies to implement quality management systems, international regulatory requirements related to quality systems, risk management, labelling and Unique Device Identification (UDI) requirements. She is actively involved in AAMI Sterilization Standards, ISO/TC 145, ISO/TC 198 and ISO/TC 210 work groups and is the convener of ISO/TC 210 WG3. She is also involved in Regulatory Affairs Professionals Society (RAPS), and serves as the chair for the Twin Cities Chapter, is a leader of the UK Local Networking Group, a member of the RAPS European Committee (REC), and a member of the RAPS Awards Committee.
Dr. Christiana Hofmann has an educational background as a Biologist and quickly developed a main interest in the bio-medicinal area. Dr. Hofmann performed a PhD at the Helmholtz Research Center in cooperation with the Technical University of Munich in the field of Toxicology with a focus on risk analysis. After gaining several years of experience within the pharmaceutical industry and working with Novartis Dr. Hofmann joined TÜV SÜD in 2016 as a team lead responsible for experts and auditors for non-active medical devices as well experts for Art 117 (combination products MDR). Since May 2021 Christina has taken over the role the "Regional Manager Focus Topics Article 117 & Annex XVI MDR".
Dr. Neff has worked in the areas of medical devices, pharmaceuticals, and biotechnology for over 16 years, joining the bitop AG in January 2022. Bitop AG is an internationally operating company that focuses on the development and distribution of proprietary over the counter (OTC) products based on Ectoin®, as well as on the supply of Ectoin® natural, and Glycoin® natural as effective cosmetic active ingredients to global cosmetic manufacturers and brands. Previously, she held Regulatory Affairs and Clinical Affairs positions at Sartorius Stedim Biotech, bess AG, Bayer Health Care, PAREXEL Consulting, Berlin Heart, and Biotronik. Her experiences include a broad range of medical devices e.g. tracheobronchial stents, ventricular assist devices, tumor markers, and substance based medical devices as well as different types of pharmaceuticals. Prior to joining the industry Dr. Neff worked as a veterinarian in small and large animal practice as well as for the German Primate Center. Dr. Neff holds a Regulatory Affairs Certification (RAC). She is the Vice Chair of the European Council of RAPS (Regulatory Affairs Professional Society) and board member of the RAPS German Chapter.
Charlie Mortazavi is a senior regulatory affairs manager at Sanofi with more10 years combined experience in global drug development and regulatory strategy covering multiple therapeuticarea. He has been responsible for successfully filing and securing worldwide approvals for multiple investigational, new and supplemental drug applications. Charlie is also involved via major trade associations in pharmaceuticals policy and regulatory emerging trends (ICH, FDA, EMA) with emphasis on advanced therapies (gene and cell therapy) and clinical development. Prior to Sanofi, Charlie held regulatory positions at Pfizer, IPSEN and GSK. Charlie earned his Doctor of Pharmacy degree from the University Catholic of Louvain in Belgium with a specialized masters degree in drug regulation from the School of Pharmacy of Strasbourg in France.
Ary Saaman is seasoned professional in the medical devices and drug-device combination products industry, with a broad background in quality management, regulatory affairs management, and technology management. He currently serves as an independent medical device technology consultant with QARA-Essentials, leveraging 30+ years of hands-on international experience with the life cycle management of medical devices and technologies. Ary is also a founding member of the RAPS Switzerland Chapter, now serving as its Executive Secretary and Treasurer.
Colette Shortt is a Regulatory Director, Emerging Science & Innovation, Global Franchise Organization. Before joining J&J, Colette was Science Director at Yakult and held a Research Nutrition position at SmithKline Beecham Consumer Healthcare. Colette has been active in the development of product-related standards and health claim substantiation throughout her career (Joint Health Claim Initiative, Council of Europe, PASSCLAIM) and coordinated one of the first successful disease risk reduction health claim regulatory submissions in Europe while at McNeil Nutritionals Ltd. Colette is a Visiting Professor to Ulster University, Registered Nutritionist and Fellow of the Association for Nutrition and the Royal Society of Medicine. She is active on the Boards of the International Life Science Institute, and the Pharmabiotic Research Institute. She is a graduate of the National University of Ireland, Cork with post-graduate qualifications in nutrition (MSc, PhD) and a business qualification (MBA) from the School of Business Management, University of Surrey. As part of her post-graduate education, she was research active in Ireland, Canada and at the Rowett Research Institute, Scotland. She was one of the founding editorial board members of Trends in Food Science & Technology.
Kate Stockman is a regulatory leader with 19+ years experience within both the Consumer and Pharmaceutical sectors. Kate has led local, regional and global regulatory teams. Her roles have spanned all stages of product development (pre- and post-licensing) and across variety of healthcare product categories ie Rx & OTC medicines, medical devices, dietary supplements & cosmetics. Kate has a strong focus on delivery with a track record of developing innovative regulatory strategies that have delivered multiple new, competitive product approvals across a broad range of complex geographies. Kate is a highly effective people leader and valued business partner
Pallavi Trivedi has 20 years of executive career experience in regulatory affairs in world-class enterprises, multi-national organizations and entrepreneurial ventures in the pharmaceuticals industries, Pallavi is an expert in leading global regulatory strategy and product development. She is adept in strategic leadership of global registrations, compliance and life cycle management with a proven success record in handling a variety of complex biopharmaceuticals, food supplements and consumer healthcare products throughout the product life cycle. Pallavi is a result focused and detail-oriented professional with demonstrated success in building & motivating high performing teams.
Robert van Boxtel is Principal Consultant and management team member at Medical Device Project B.V. in the Netherlands. For more then 10 years, he supports the medical device industry with QA and RA related consultancy, focusing on the EU and USA. Additionally, he provides training to the industry, Notified Bodies and Competent Authorities on EU MDR, ISO 13485, Risk Management, auditing etc. He is hired by the Dutch Standards Institute (Royal NEN), as SME for training on ISO 13485 and MDD/MDR. Furthermore, he participates in TC210 discussions on quality management systems, risk management, PMS and is member of the Dutch horizontal standards committee. Robert is Board Member of both the RAPS Netherlands Chapter and the RAPS European Council. Before joining Medical Device Project B.V., he worked at KEMA Quality Notified Body (now Dekra Certification) and in the medical device industry in several roles in design and production, both in the EU and the USA. As a result he has over 25 years of experience in the medical device industry.