21st Century Global Harmonization of Healthcare Regulation: A USFDA Perspective

Join us for the upcoming Health, Business and Society (HBS) Public Talk, "21st Century Global Harmonization of Healthcare Regulation: A USFDA Perspective". 

Organized by the Institute of Health Economics and Management Asia-Pacific (IHEM Asia-Pacific), ESSEC Business School, the HBS Public Talk series was initiated with the aim of facilitating and disseminating insights to relevant stakeholders in the industry, so as to deliver meaningful recommendations to both public and private policy decision makers.

EVENT DETAILS

Date and Time: Wednesday, 9 September 2015, 7:30pm - 9:00pm

Venue: ESSEC Asia-Pacific, 2 One-North Gateway, Singapore 138502

Kindly contact us at essecasia@essec.edu to register for the talk.

ABSTRACT

This talk will provide participants with a behind-the-scene understanding of the scope, structure and operations of the US Food & Drug Administration (USFDA), as well as how the USFDA impacts every aspect of the changing American healthcare environment and it’s interactions and impact with both the developed and developing worlds. Specific emphasis will be placed on agency interactions with regulated industries (biopharmaceuticals, medical devices, dietary supplements) throughout their lifecycle. 

Participants will be able to anticipate, decipher, and understand not only the complex operations of the USFDA but also its potent and nuanced impact on medicines regulation, developmental innovation (both incremental and discontinuous), and how dynamic “regulatory velocity” (speed + accuracy + public health need = “regulatory velocity”) is helping to reinvent healthcare in the United States and around the world.

SPEAKER

Mr. Peter PITTS is President of the Center for Medicine in the Public Interest. A former member of the United States Senior Executive Service, Peter was FDA’s Associate Commissioner for External Relations, serving as senior communications and policy adviser to the Commissioner. He supervised FDA's Office of Public Affairs, Office of the Ombudsman, Office of Special Health Issues, Office of Executive Secretariat, and Advisory Committee Oversight and Management. He served on the agency’s obesity working group and counterfeit drug taskforce and is a Special Government Employee (SGE) consultant to the FDA’s Risk Communications Advisory Committee. In 2010, he was named by Modern Healthcare magazine as one of the 300 “most powerful people in American healthcare.”

MODERATOR

Dr. Allen LAI is the Director of IHEM Asia-Pacific at ESSEC Business School, and Programme Director of the ESSEC MSc in Management of Health Industries. A surgeon by training, Dr. Lai has been a group leader in clinical process