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The regulatory function is vital in making safe and effective healthcare products available worldwide. Individuals who ensure regulatory compliance and prepare submissions, as well as those whose main job function is clinical affairs or quality assurance are all considered regulatory professionals.
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Like all professions, regulatory is based on a shared set of competencies. The Regulatory Competency Framework describes the essential elements of what is required of regulatory professionals at four major career and professional levels.
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For 20 years, our flagship publication, Fundamentals of US Regulatory Affairs, has been giving regulatory professionals the insights and answers they need, right at their fingertips.
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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.
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).
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.
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.
Jennifer Neff, DVM, PhD, MBA, RAC 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 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 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 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 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.
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