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Bethesda North Marriott Hotel and Conference Center

Mar 03, 2016 7:30 AM - Mar 04, 2016 4:00 PM

5701 Marinelli Road, , North Bethesda, MD 20852 , USA

Marketing Pharmaceuticals 2016

Discuss the complexity of marketing and how to promote pharmaceuticals, biologics, and medical devices in an effective yet compliant manner in an evolving environment.

Session 5: FDA Update: Recent Enforcement Actions and Guidances

Session Chair(s)

Wayne  Pines

Wayne Pines

President, Health Care

United States

Are you aware of all of the current issues, laws, and new guidances regarding the promotion of prescription drugs, biologics and medical devices? In this session, FDA panelists will review the latest on policy development, enforcement and the FDA’s future initiatives as well as the new guidances that describe the FDA’s current thinking on important issues that have been raised by industry and the FDA’s recommendations in these areas.

Speaker(s)

Thomas W. Abrams, MBA, RPh

CDER Update

Thomas W. Abrams, MBA, RPh

Former FDA, United States

Retired, Director, Office of Prescription Drug Promotion, OMP, CDER

CDR Roberta  Szydlo, MBA, RPh, RAC

FDA Update: Recent Enforcement Actions and Guidances–Update on eSubDraft Guidance

CDR Roberta Szydlo, MBA, RPh, RAC

FDA, United States

Office of Prescription Drug Promotion, CDER

Sonny  Saini, PharmD

CBER Update

Sonny Saini, PharmD

FDA, United States

Regulatory Health Project Manager

Deborah  Wolf, JD

CDRH Update

Deborah Wolf, JD

FDA, United States

Regulatory Counsel, OPEQ , Regulatory Policy, CDRH

Thomas J. Moskal, DVM

CVM Update

Thomas J. Moskal, DVM

FDA/CVM, United States

Veterinary Medical Officer

John  Weiner, JD

An Introduction to Combination Products

John Weiner, JD

FDA, United States

Associate Director for Policy, Office of Combination Products, OCPP, OC

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