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This comprehensive resource covers product change evaluation, postmarket surveillance, audit/inspection compliance, and various other laws and regulations pertaining to maintaining a product on the market.
Hear from leaders around the globe as they share insights about their experiences and lessons learned throughout their certification journey.
The RAPS EU Board of Directors is the governing, policy-making and strategic body that guides RAPS in serving the regulatory professional in Europe. The EU Board of Directors has the legal and fiduciary responsibility to ensure the long-term viability and integrity of RAPS in Europe. The EU Board of Directors plays an integral role in maintaining a system of checks and balances that enables the organization to make strategic business decisions in that region.
Rainer Voelksen is director RA/QA of CAIRDAC, the first company in the world to successfully develop a self-sustainable pacemaker pledging over 15 years of lifespan. He has 30 years of experience in regulatory, including running his own regulatory consulting firm. Prior to launching his company, Voelksen was with MicroPort CRM as director of regulatory affairs and regulatory intelligence. He spent several years as project manager at the Swiss Federal Office of Public Health, working to implement the MDR and IVDR into Swiss law. He has served in regulatory and leadership roles at Swissmedic, the Swiss competent authority for therapeutic products, Australia’s Therapeutic Goods Administration, and medical technology and biotech companies in Europe and Australia. Voelksen is a RAPS Fellow and served as chairman of RAPS’ board of directors.
Gert Bos, PhD, FRAPS, is CSO, executive director and partner with Qserve Group in the Netherlands. He is an expert in European regulations with 28 years of experience in life sciences, including 15 years as auditor, product reviewer, regulatory specialist, and head of notified body. Bos has been leading the notified bodies in Brussels for many years and has strongly supported the regulatory debate with the EU Commission, EU Parliament, and the EU Council of Ministers. He has a PhD in biomaterial sciences, and postdoctoral degrees in controlled release of drugs and gene therapy. He is a RAPS Fellow, a founding member of the RAPS European Council, a founding board member of the RAPS Netherlands Chapter and the current president of the RAPS Board of Directors.
Glenn N. Byrd, MBA, RAC, is president of GByrd AdPromo Solutions LLC, a consulting company providing expert advertising and promotion regulatory support to the biopharmaceutical industry. He is a part-time faculty member teaching regulatory affairs at the University of North Carolina Wilmington. Byrd previously served in a regulatory leadership role for more than 11 years at AstraZeneca/MedImmune and has held numerous regulatory and leadership roles in pharma, biotech, and device organizations over his 30-year career. He spent 10 years at FDA, including six years in the Center for Devices and Radiological Health as a device reviewer, and four years in the Center for Biologics Evaluation and Research as head of the Advertising and Promotional Labeling Branch. He received his MBA from Hood College.
Bill McMoil joined RAPS in 2017 as vice president of finance, information technology and operations, and was promoted to chief operating officer in 2019. He was named RAPS interim executive director in April 2020. McMoil has worked in a variety of B2B and B2C for-profit businesses, from private-equity-backed startup software companies to publicly held telecom companies and global ISO certification bodies. While at RAPS, McMoil successfully managed the complete replacement and overhaul of the RAPS website and association management system, and oversaw the delivery of RAPS’ business continuity initiative, which has allowed RAPS staff to seamlessly transition to remote work and maintain full productivity while doing so. McMoil also has overseen significant growth of RAPS’ net assets since 2016.
Salma Michor is founder and CEO of Michor Consulting and Trade Services GmbH, serving such clients as Johnson & Johnson, Novartis, Pfizer and CSL Behring. Previously, Michor worked for Chiesi-Torrex, Wyeth Whitehall Export Croma Pharma GmbH. She teaches regulatory affairs and clinical strategies at the University of Krems, Austria, and is an independent expert to the European Commission. Michor is a member of the RAPS European Board. She holds a PhD in Bio engineering and an MSc in food and biotechnology from the University of Applied Life Sciences in Vienna, Austria; an MSc from King’s College, University of London in food technology; and an MBA from Open University and has earned the RAC (EU and Global). She is a Chartered Manager and a fellow of the Chartered Management Institute.