November 9-11, 2020 | Virtual Conference

SPEAKERS

Judith Zander, M.D.

Director
Office of Pharmacovigilance and Epidemiology, OSE, CDER, FDA

Sarah Yim, M.D.

Director
Office of Therapeutic Biologics and Biosimilars, CDER’s Office of New Drugs (OND), FDA

Siva Vaithiyalingam, PhD

Vice President of Regulatory Affairs
Cipla LTD

Rachel Turow, J.D.

Associate General Counsel, Regulatory Law & Policy
Teva Pharmaceuticals

Scott Tomsky

VP, North America
Regulatory Affairs, Generics, Teva

Aloka Srinivasan, PhD

Principal and Managing Partner
RAAHA, LLC

David Rosen, J.D.

Partner
Foley & Lardner LLP

Jonathan Resnick

Project Management Officer
Electronic Submissions Capability Team, DDMSS, OBI, OSP, CDER, FDA

Diane Raccasi, BS

Principal Consultant
Paraxel International

Robert “Bob” Pollock, MS

Senior Advisor, Outside Director to the Board
Lachman Consultant Services, Inc.

Laura Pethick, PharmD, MBA

Director, Patient Safety
Tolmar Pharmaceuticals, Inc.

Lisa Parks, RPh

Vice President of Sciences & Regulatory Affairs
AAM

Gerald Dal Pan, M.D., MHS

Director
Office of Surveillance and Epidemiology (OSE), CDER, FDA

Brian McCormick

VP & Chief Regulatory Counsel, Head Global Regulatory Policy
Teva Pharmaceuticals

Markham Luke, M.D., PhD

Director
DTP, ORS, OGD, CDER, FDA

Doug Long

Vice President of Industry Relations
IQVIA

Bing Li, PhD

Director
OB, OGD, CDER, FDA

Dan Leonard

President and Chief Executive Officer
AAM

Kiran Krishnan, PhD

Senior Vice President, Global Regulatory Affairs
Apotex Inc.

Michael Kopcha, PhD, RPh

Director
Office of Pharmaceutical Quality (OPQ), CDER, FDA

Kurt Karst, J.D.

Director
Hyman, Phelps & McNamara, P.C.

Vineet Kacker, PhD

Co-Founder, Managing Director and Global Technical Head
APCER Life Sciences, Inc.

Stephen Hahn, M.D.

Commissioner
FDA

Kishore Gopu, MS, MBA

Director, REMS Operations
Teva Pharmaceuticals

David Gaugh, RPh

Senior Vice President, Sciences & Regulatory Affairs
AAM

Lynne Ensor, PhD

Vice President, Technical
Parexel International

Martin Ehlert, PhD

Vice President
Research and Development, Apotex Inc.

Candis Edwards

Senior Vice President, Regulatory Affairs
Amneal Pharmaceuticals LLC

Charlie DiLiberti

President
Montclair Bioequivalence Services, LLC

Joyce DelGaudio

Sr. Director, Regulatory Affairs, Generics
Teva Pharmaceuticals

Thomas Cosgrove, J.D.

Partner
Covington & Burling LLP

Hillel Cohen, PhD

Executive Director, Scientific Affairs
Sandoz, Inc

Sally Choe, PhD

Director
Office of Generic Drugs (OGD), CDER, FDA

Ee-Sunn (Joanne) Chia, PhD

Division Director
Division of New Drug Products (DNDPIII), Office of New Drug Products (ONDP), OPQ, CDER, FDA

Zhi Chen, MS, RAC

Associate Director of Regulatory Affairs
Glenmark Pharmaceuticals Inc., USA

Ethan Chen, PMP, MSE, MBA

Director
DDMSS, OBI, OSP, CDER, FDA

Patrizia Cavazzoni, M.D. 

Acting Center Director
CDER, FDA

Charles Bon, MS

President/Founder
Biostudy Solutions, LLC

Elaine Herrmann Blais, J.D.

Partner
Goodwin Procter LLP

Karthik Balasubramanian, PhD

Director, Combination Products and Semisolids, Generic CPD
Teva Pharmaceuticals

Donald Ashley, J.D.

Director
Office of Compliance (OC), CDER, FDA

Get Started + Register

Whether you are an AAM member, general attendee, speaker or exhibitor, you can be part of the premier scientific and regulatory conference for the U.S. generics and biosimilars industry.

Get Started + Register

Whether you are an AAM member, general attendee, speaker or exhibitor, you can be part of the premier scientific and regulatory conference for the U.S. generics and biosimilars industry.

Get Started + Register

Whether you are an AAM member, general attendee, speaker or exhibitor, you can be part of the premier scientific and regulatory conference for the U.S. generics and biosimilars industry.

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