Strategic Learning Level:
Content is intended for individuals who are well-versed in most/all concepts associated with the topic(s) and are involved in translating knowledge into effective plans and strategy. They work with other teams throughout the product lifecycle. Typical job titles at this level are director/vice president/executive director/CEO/experienced reviewer/section manager/division director.
Please note this list of sessions is not exhaustive and may be subject to change.
Session Leader/Speaker: Wendy Schroeder, BSN, CCRC, CRCP – NAMSA
Speaker (Remote): Zhiping Li, Bachelor – NAMSA
Speaker (Remote): Michael Vogl
Speaker: Chyue Yie Chew, RAC (EU & US) – ZP Therapeutics, a Division of Zuellig Pharma
Speaker: Fazlin Azura Azlan, Registered Pharmacist – ZP Therapeutics, a Division of Zuellig Pharma
Speaker: Chyue Yie Chew, RAC (EU & US) – ZP Therapeutics, a Division of Zuellig Pharma
Speaker: Fazlin Azura Azlan, Registered Pharmacist – ZP Therapeutics, a Division of Zuellig Pharma
Speaker: Lisa Ryan, BSc, HTL (ASCP BOR) – NAMSA
Speaker: Rashmi Kulshrestha, PhD – Regulatory Wisdom
Speaker: Sean Smith, MA – Huma.AI
Speaker: Fang Li, PHD, RAC – Graybug Vision, Inc
Speaker: Lindsey Summers, MBA – Day One Biopharmaceuticals
Speaker: Susan E. Carino, MBA, MS, PMP, RAC – Integrated Project Management Company, Inc.
Speaker: Mary E. Wilhelm, DRSc, RAC US, RAC EU – Ascendis Pharma
Speaker: Nancy Pire-Smerkanich, DRSc – Department of Regulatory & Quality Sciences USC School of Pharmacy
Session Leader/Speaker: Ana Sengupta, MS, MBA, RAC – AbbVie
Speaker: Orin Chisholm, GCULT, PhD, SFHEA, FRAPS – University of Sydney
Session Leader/Speaker: Aditi Khurana, MBA, PMP, RAC – Asher Biotherapeutics
Speaker: Heidi Christl Marchand, PharmD – Gilead Sciences Inc. - ENTERPRISE
Speaker: Khushboo Sharma, MBA – Accumulus Synergy
Speaker (Remote): Mary Ann Slack – U.S. FDA Center for Drug Evaluation and Research
Session Leader/Speaker: Lisa L. Pritchard, BSEEE – DuVal & Associates, P.A.
Speaker: Kathy Herzog, BSME – DuVal & Associates, P.A.
Speaker (Remote): Peter Yang, PhD – Food and Drug Administration
Session Leader/Speaker: W. Alex Smith, MBA, RAC – Hogan Lovells LLP
Speaker: Balazs Bozsik, MSc, MBA – Medical Audit, NAM Knowledge
Speaker: Hamish King, RAC, CFA – Cisema / RAPS Member
Speaker: Kuniki Imagawa, MSc – PMDA
Session Leader/Speaker: Michael Craig, BSc Pharm, M.P.S.I – Parexel
Session Leader/Speaker: Chris Whalley – Seagen Inc.
Moderator: Mathilda Fienkeng, PharmD, MS, RAC, CDR USPHS – Office of Medical Policy, FDA
Session Leader/Speaker: Monique Carter, MS,RAC – Pfizer
Speaker: Zaida Recinos-Vasquez, MS, MS – Pfizer
Speaker (Remote): Alysha Croker, PhD – Health Canada
Speaker (Remote): Lola Fashoyin-Aje, MD, MPH – Food and Drug Administration
Speaker (Remote): Markus Balkenhol – Akra Team GmbH
Speaker: Richard G. Holborow, Medical/Professional – (British Standards Institute) BSI
Speaker (Remote): Rachel K. Gibbs, PhD – NAMSA
Speaker: Regina M. Fullin, Compliance Team, LLC – Compliance Team, LLC
Speaker: Kamana Singh, BVSc, MVSc, PSM-MMB, MBA, RAC(US) – Opus Regulatory
Speaker: Brian Godwin, RAC – Ethicon
Session Leader/Speaker: Andy Papas, PhD, MBA – NSF International, Health Sciences Division
Speaker: Adrienne Lenz, MS, RAC – Hyman, Phelps & McNamara, P.C.
Moderator: Frank Pokrop, RAC, CQE, CSQE, CPGP, CISA – Quidel
Speaker (Remote): Ken Skodacek – FDA/CDRH
Speaker (Remote): Sheryl Lard-Whiteford, PhD – Center for Biologics Evaluation and Research, US FDA
Speaker (Remote): Virginia Behr – Food and Drug Administration, Center for Drug Evaluation and Research
Speaker (Remote): Erica Katherine, MS – USFDA Office of Regulatory Affairs (ORA)
Moderator: Megha Deviprasad Iyer, MS, RAC – Thermo Fisher Scientific
Session Leader/Speaker: Alex May, M.S. – Biotechnology Innovation Organization
Speaker: Kim Wolfram, MS – Biogen
Speaker: Ben Stevens, PhD, MPH – GSK
Speaker (Remote): Joel Welch, PhD – OBP/OPQ/CDER/FDA
Session Leader/Speaker: Micheline Awad, MBA – Turning Point Therapeutics, Inc.
Speaker: Lisa M. Kelsey, MA LMFT – Genentech, Inc.