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The Regulatory Affairs Professionals Society (RAPS) is the largest global organisation of and for those involved in regulation of healthcare and related products, including medical devices, pharmaceuticals, biologics and nutritional products.

RAPS stepped up its presence in Europe in response to growing membership demand, announcing plans to invest more than €2 million over three years implementing a strategic growth plan.

As part of its commitment, RAPS hosts several face-to-face events in Europe and will host the second RAPS Regulatory Conference - Euro Convergence 2020 in Brussels 11-13 May 2020. RAPS also launched its new RAPS European Council (REC) to help support the growing member base and volunteer network across Europe.
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If you are interested in being a part of the global RAPS community,  learn more about RAPS, become a member and join our online forum or take advantage of our EU events and publications
 

RAPS European Council (REC) 2019 - 2021

Lena Cordie-Bancroft
Lena Cordie-Bancroft headshot 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.

Philippe Auclair, PhD
Philippe Auclair, PhD  headshot 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).

Roy Jamieson
Roy Jamieson headshot 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.

Anja Wiersma, PhD
Anja Wiersma, PhD headshot 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.

Jennifer Neff, DVM, PhD, MBA, RAC
Jennifer Neff, DVM, PhD, MBA, RAC headshot 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.

Susana de Azevedo, PhD
Susana de Azevedo, PhD headshot 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.

Andreas Wiegand
Andreas Wiegand headshot 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.

Michael Maier
Michael Maier headshot 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
Irena Milobratovic headshot 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.

European Contact

Keren Deront
RAPS European Liaison
Tel: +33 781 58 53 34
Email: kderont@raps.org
 
European Advisory Committee

RAPS European Council (REC)

RAPS European Council (REC) is comprised of senior regulatory professionals from Belgium, Germany, Spain, Switzerland and the UK. They steer EU strategic directions, represent RAPS with EU and national authorities, and further understanding of the global and local context of regulations across markets—focusing on what is most relevant to Europe.
RAPS Online Learning

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Regulatory Affairs Certification

Regulatory Affairs Certification (RAC)

An individual certification for our global industry

Join the ranks of the most successful regulatory professionals with your RAC. This accredited credential is the only globally recognised certification for the regulatory industry.

The RAC highlights your knowledge through a region-specific lens. Where is your expertise? 

  • RAC (EU): Knowledge of European Union regulations
  • RAC (US): Knowledge of US regulations
  • RAC (CAN): Knowledge of Canadian regulations
  • RAC (Global): Knowledge and critical thinking skills related to the international practice of regulatory affairs, with special attention paid to global standards from ICH, GHTF (through IMDRF), WHO and ISO
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Regulatory Focus

Regulatory Focus/Regulatory Intelligence

Regulatory Focus is the leading source for quality, timely, regulatory news, information and analysis.

  • Easy to read daily regulatory intelligence through Regulatory Reconnaissance and a daily newsletter, RF Today—both of which are available free of charge
  • RAPS members receive access to in-depth articles written by regulatory professionals on topics of global and regional Interest
  • Information for regulatory professionals at all career levels and others interested in healthcare product regulation throughout product lifecycles
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