Applied Learning Level:
Content is appropriate for individuals who have strong knowledge of the topic(s) and/or demonstrated well-developed regulatory technical knowledge and skills. Regulatory Affairs Certification (RAC) is targeted to professionals at this level. Typical job titles at this level are manager/senior manager/reviewer.
Please note this list of sessions is not exhaustive and may be subject to change.
Speaker: Shannon Hoste, MS – Agilis Consulting Group
Speaker: Denise Forkey, MS BME – UserWise, Inc.
Speaker: Shannon Clark, PE – UserWise, Inc.
Speaker: Denise Wagner, MS – Agilis Consulting Group
Session Leader/Speaker: Gert W. Bos, MSc, PhD, FRAPS – Qserve Group
Speaker: Sabina L. Hoekstra-van den Bosch, PharmD FRAPS – TÜV SÜD Medical Health Services
Speaker: Kevin Butcher – NAMSA
Session Leader/Speaker: Stephen C. Weber, MD – Johns Hopkins Department of Orthopedics/NDA Partners NDA Partners
Speaker: Flora Sandra Siami, MPH – Medical Device Innovation Consortium
Speaker: Justin Timbie, PhD – RAND
Speaker: Tracy Yu, MSc – BradyKnows Medical, LLC
Speaker: Sara Jafari, PhD – Gmed NA
Speaker: Tshetsana Senau – Botswana Medicines Regulatory Authority
Session Leader/Speaker: Carol M. Cooper, MS, RAC, IM(ASCP), RM(AAM) – CM Cooper & Associates
Speaker: Monika Bhatt, LL.M – Siemens Healthineers
Speaker: Erik R. Vollebregt, LLM – Axon Lawyers
Session Leader/Speaker: Kirsten Messmer, PhD, RAC – Agency IQ
Speaker: Kevin Healy, PhD, RAC – Enzyvant Therapeutics, Inc.
Speaker: Mary S. Newman, BS, MS – Taysha Gene Therapies
Session Leader/Speaker: Kerrie Nagrod, MSJ – Bristol-Myers Squibb
Speaker: Michelle P. Pernice, PharmD – Pardes Biosciences
Speaker (Remote): John Concato, MD, MS, MPH – United States Food and Drug Administration, Center for Drug Evaluation and Research
Session Leader/Speaker: Alex Laan, Dipl.-Ing. – NAMSA
Speaker: Julien S. Senac, PhD – TUV SUD
Speaker: Elisabeth PhD Dequeker, PhD – University Hospital Leuven, Belgium
Speaker: Sharon Goldfarb – SG Consulting-Pro Ltd.
Speaker: Anike Freeman, M.Eng. – RQM+
Session Leader/Speaker: Laura Sheppard, MBA, MA – Certara
Speaker: Monica Tocchi, MD – Meditrial USA Inc.
Speaker: Karl-Heinz Huemer, MD, PhD – AGES (Austrian Agency for Health & Food Safety)
Speaker: Debra Kridner, MA – Meditrial
Moderator: Vicki Bebeau, BSN – Self Employed
Speaker: Kristin Forßmann, MD – Meditrial GmbH
Session Leader/Speaker: Meg Mucha, RAC, FRAP – Philips Healthcare
Speaker: Scott Brewer – Ricoh USA
Speaker: Tracey Fox, MS, RAC – Optum
Session Leader/Speaker: Mindy McCann – Qserve Group
Speaker: Erik R. Vollebregt, LLM – Axon Lawyers
Session Leader/Speaker: Olga van Grol-Lawlor, MPhil – Boston Scientific
Speaker: Gert W. Bos, MSc, PhD, FRAPS – Qserve Group
Speaker: Sabina L. Hoekstra-van den Bosch, PharmD FRAPS – TÜV SÜD Medical Health Services
Speaker: Natalia Wilson, MD MPH – Arizona State University/Center for Healthcare Delivery and Policy
Speaker: Rosanne Middleton – LifeScan
Speaker: Dinar Suleman, RAC – LifeScan