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Each session will have presentations from U.S. FDA and/or European regulators and biosimilar
developers. All will discuss best practices, potential pitfalls and
lessons learned from the most recent biosimilar approvals.
You will hear from the following regulators:
U.S. FDA:
- Laurie Graham, Acting Director, Division of Internal Policies and Programs, CDER
- Maria-Teresa Gutierrez Lugo, Chemist, CDER
- Steven Kozlowski, MD, Supervisory Medical Officer, CDER
- Emanuela Lacana, PhD, Associate Director for Biosimilars and Biologics Policy, CDER
- Patrick Lynch, PhD, Biologist, CDER
- Leslie Rivera Rosado, PhD, Director Regulatory Review Officer, CDER
- Marjorie Shapiro, PhD, Chief, Laboratory of Molecular and Developmental Immunology, CDER
- Joel Welch, PhD, Acting Review Chief, CDER
European Regulatory Agency:
- Niklas Ekman, PhD, Senior Researcher, Finnish Medicines Agency
- Birgit Schmauser, PhD, Quality Assessor, Pharmaceutical Biotechnology, Inspections Quality, BfArM (Federal Institute for Drugs and Medical Devices)
Additionally, you will hear from industry speakers from Amgen, Sandoz, Coherus, AstraZeneca, Samsung and others.
Don’t miss this opportunity to share your questions and concerns with the experts!
Register by May 31 and save up to $200!
Book your hotel room by May 29 to receive the PDA Conference rate.
Call the Hyatt Regency Bethesda at +1
(301) 657-1234 and ask for the "PDA Biosimilars Conference" rate or make your reservation online.
Preceding this Conference, on Jun. 19-22, PDA Education will be holding the Biotechnology Course Series.
Comprised of three courses, this course series has been designed to
teach individuals at all knowledge levels about the important elements
of biotechnology. Learn more and register now! |
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Parenteral Drug Association (PDA) 
