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Carmen M. Wagner, Ph.D.
President
Strategic Compliance International, Inc (SCI)
2500 Regency Parkway
Cary, North Carolina 27511
(919) 460-3900
cwagner@hottopicsworkshops.com
www.hottopicsworkshops.com
Dr. Carmen M. Wagner is the founder and President of Strategic Compliance International Inc, in Cary, North Carolina. SCI provides services in the area of regulatory compliance/quality assurance for the pharmaceutical, device, biotechnology and vaccine industries, including cell therapy. Dr. Wagner has held a variety of quality related positions in the health industry, where she has worked for more than twenty years. Her work experience includes tenures at E.I. DuPont, Johnson & Johnson, American Cyanamid, Wyeth-Lederle Vaccines, and Wyeth Laboratories. More recently she was Vice President, Quality and Technical Services at MERIX Bioscience, Durham, NC, and Vice President of Regulatory Compliance and Technology Transfer at Serentec Inc., Raleigh, NC. Dr. Wagner is an active member of PDA, ISPE, and ISCT, is a frequent lecturer, and has published extensively. For the last ten years, Dr. Wagner has also held an Adjunct Professor position at Campbell University, in Buies Creek, North Carolina, where she helped develop a course in Product and Process Validation.
Catherine Bernard, Ph.D.
President
International Regulatory Affairs Services, Inc.
10626 Wagon Box Way
Highlands Ranch, Colorado 80130
(303) 683-3512 tel/fax
(720) 939-9952 cell
cbernard@hottopicsworkshops.com
www.hottopicsworkshops.com
Dr. Catherine Bernard is the founder and President of International Regulatory Affairs, Inc. Dr. Catherine Bernard has a Ph.D. in cell biology and biochemistry, and over 10 years of industry experience. Since 1995, she has worked in the Regulatory Affairs field. She started her career in research in the US and later moved back to Europe, to work as a regulatory affairs manager in two different CROs based in the UK. There, she gained extensive experience in European registration (mutual recognition procedure and centralized procedure) for a wide variety of products and was involved with all the different parts of an EU dossier, including writing expert reports on the three main sections, clinical summary, assembly, submission and follow-up. Since 1999, Dr. Bernard has been consulting on FDA and European regulatory affairs, and has attended several pre-submission meetings with European Agencies as well as the FDA. Dr. Bernard is an active member of DIA. BIRA, and RAPS.
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