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.

Susana de Azevedo, PhD headshot

Susana de Azevedo, PhD, Chair

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.

Jennifer Neff, DVM, PhD, MBA, RAC headshot

Jennifer Neff, DVM, PhD, MBA, RAC, Vice Chair

Jennifer Neff is director of regulatory and medical affairs at bess AG. She has worked in medical devices, pharmaceuticals and biotechnology for more than 13 years. Prior to bess, Neff held regulatory and clinical affairs positions at Bayer, PAREXEL Consulting, NOXXON Pharma AG, Berlin Heart GmbH and Biotronik GmbH. She has worked with a broad range of devices and drugs. Prior to working in industry, Neff was as a veterinarian in small- and large-animal practice and worked for the primate genetics division of the German Primate Center. She received her PhD from the University of Veterinary Medicine of Hannover and her MBA from FOM University of Applied Sciences in Germany. Neff holds the RAC credential and is the vice chair of the RAP European Council.

Philippe Auclair, PhD  headshot

Philippe Auclair, PhD

Philippe Auclair is senior director, regulatory strategy and advocacy at Abbott. He represents European industry in various European Commission expert groups and actively participates as a trainer in programs organized by regulatory authorities in various geographies. Auclair has served since 2015 as an advisor to the Asian Harmonization Working Party Technical Committee. He is Chairman of the postmarket surveillance and notified body working groups of the European medical device manufacturers’ trade association, Medtech Europe. Auclair received RAPS’ Global Leadership Award in 2010, was selected RAPS Fellow in 2012 and is also the proud recipient of an FDA CDRH director’s “Special Citation” for his work with the Global Harmonization Task Force (GHTF).

Lena Cordie-Bancroft

Lena Cordie-Bancroft

Lena Cordie-Bancroft is the president and principal consultant at Qualitas Professional Service, where she works with medical device and IVD companies to implement ISO 13485 and FDA-QS-regulation-compliant quality management systems supporting processes to comply with FDA and international regulatory requirements. Cordie-Bancroft helps clients with quality systems, risk management and global regulatory compliance related to labeling and Unique Device Identification (UDI) requirements. She is a member of Association for the Advancement of Medical Instrumentation (AAMI) Sterilization Standards Committee, ISO/TC 198 and ISO/TC 210 work groups. She is an active member of RAPS, chairperson for the RAPS Twin Cities Chapter, member of the RAPS European Council and a leader of the UK Local Networking Group.

Roy Jamieson

Roy Jamieson

Roy Jamieson is an independent regulatory chemistry, manufacturing and controls (CMC) consultant at Jamieson Combinations AB. He is a pharmacist with extensive, wide-ranging experience in the pharmaceutical industry, as well as an experienced regulatory quality/CMC professional. Jamieson has served as a reviewer at the UK’s Medicines and Healthcare products Regulatory Agency and spent more than 20 years with large pharmaceutical companies leading numerous global projects from First Time in Human studies through Marketing Authorisation and launch. Jamieson’s key area of expertise centers on biopharmaceutics aspects of solid oral dosage forms and the bridge between quality performance and the pharmacokinetic profile linked to safety and efficacy, covering critical review aspects enabling access to high quality medicines. He also maintains a keen interest in the progress of African regulatory harmonization.

Michael Maier headshot

Michael Maier

Michael Maier has more than 20 years of hands-on experience in the medical device industry working on design and development projects, product industrialization, and regulatory and quality affairs. He is a trained notified body auditor for ISO 13485 and the EU Medical Device Directive, and has served numerous international compliance programs. Maier helps clients determine the most appropriate regulatory pathways and strategies to bring devices to market, and conducts regulatory troubleshooting and compliance audits for product files, clinical investigation files and quality systems. He holds an MBA in corporate management and a masters in medical engineering. He earned the RAC Devices in 2019. Maier is a member of several standardization committees related to medical devices. He is frequent speaker at international events for medical devices, quality and regulatory affairs topics.

Irena Milobratovic headshot

Irena Milobratovic

Irena Milobratovic is a senior regulatory affairs manager at Arriello. She has more than 15 years combined experience in pharmaceutical and medical device regulatory affairs, pharmacovigilance and market access. Milobratovic’s expertise lies within the processes which establish and keep Marketing Authorisation Holders compliant, such as medicinal products release to market, product information, labeling and regulatory compliance, as well as liaising with European and global health authorities. She has a masters of pharmacy and holds the RAC (EU) credential. Milobratovic is an active RAPS and RAPS European Council member.

Pallavi Trivedi headshot

Pallavi Trivedi, RAC

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

Robert van Boxtel is Principal Consultant at Medical Device Project B.V. and management team member. For 10 years, he supports the medical device industry on regulatory and quality related issues. Additionally he provides training to the industry, Notified Bodies and Competent Authorities on the MDR, ISO 13485, Risk Management, auditing etc. Over the last 2 years he is board member of RAPS Netherlands Chapter and is involved in organizing the RAPS meetings. He participates in several MDR implementation discussion groups and is hired by the Royal Dutch Standards Institute (NEN) as trainer. He participates in TC210 in the working groups for quality management systems, risk management, PMS and the Dutch horizontal standards committee. Before, he worked at Notified Body KEMA Quality (Now Dekra Certification) and in the industry in several roles in design and production, in both the EU as in the US.

Andreas Wiegand headshot

Andreas Wiegand

Andreas Wiegand is senior director of regulatory affairs at Siemens Health, where he built a dedicated group to handle US submissions for the company’s German-made products and directs the local regulatory team in charge of global submissions. After receiving a degree in Chemistry, he began his career in a lab developing IVD products and specialized in immunoassays. Weigand later worked in regulatory affairs for vaccines. He specialized in US regulatory affairs and earned the RAC (US), eventually broadening his responsibilities to cover worldwide registrations, including WHO prequalification. After working in countries including the US and the Netherlands, he returned to his native Germany, where he has been able to combine his experience with IVDs and regulatory affairs.

Anja Wiersma, PhD headshot

Anja Wiersma, PhD

Anja Wiersma is a medical biologist by training with a PhD in the neuropharmacological—behavioral—physiology field. She worked for eight years at the multinational pharmaceutical company, Organon, first as scientific researcher and later as a strategist, and spent more than six years at a notified body in the medical devices and in vitro diagnostics (IVD) fields. Wiersma is fully qualified as a notified body auditor in the EU for both the Medical Device Directive and the IVD Directive. She is a regulatory and quality consultant for device and IVD manufacturers and contractor for notified bodies executing design dossier reviews and CE and ISO 13485 audits as well as for executing inspections for independent organizations. Wiersma is board chair of the RAPS Netherlands Chapter a member of the RAPS European Council.

 

Not a member?

Invest in yourself—and our community. Join RAPS today!

 

Germany LNG Icon