O'Neill Institute

O'Neill Institute for National & Global Health Law - Summer Programs 2014

O'Neill Institute
O'Neill Institute

2014 Summer Program

Food and Drug Law

July 14-18, 2014
 
O'Neill Institute

Summer Program on Emerging Issues
in Food and Drug Law

Please join the O’Neill Institute for National and Global Health Law at Georgetown University for a one-week intensive summer institute exploring the domestic and international legal, regulatory, and policy framework shaping the safety and availability of foods and medicines worldwide. 

Important Dates

June 22
Application Deadline

Program Details

Program Fees

Regular Attendees

Middle/Low-income Countries:
$1,825 

High-income Countries:
$2,500 

Government and Academic Attendees
(Current government officials, students, post-docs, and non-tenured faculty)


Middle/Low-income Countries:

$1,575  

High-income Countries:
$2,250  

 

CLE Credit
CLE credits are available to attorneys admitted to a United States state bar. CLE accreditation is on a state-by-state basis.

Travel & Housing
Participants are responsible for arranging their own travel and housing.  A short list of area hotels can be found here.

Certificate of Attendance
Participants will receive a Certificate of Attendance from Georgetown University Law Center upon completion of the Summer Program.

Cancellation Policy
Registration cancellations and requests for refunds must be received in writing to oneillsummer@law.georgetown.edu by Friday, June 13, 2014.

All refund requests will be charged a $100 administrative handling fee and will be processed after the conference. 

Helpful Links

Application
Listserv 
More Information
 


 



 



 


 
Expert Spotlight - Derek Yach, SVP, Vitality Group

Derek Yach has focused his career on advancing global health. He is Senior Vice President (SVP) of the Vitality Group, part of Discovery Ltd, where he leads the Vitality Institute for Health Promotion.

He was SVP Global Health and Agriculture Policy at PepsiCo, headed global health at the Rockefeller Foundation, been a Professor of Global Health at Yale University, and is a former Executive Director for Noncommunicable Diseases and Mental Health of the World Health Organization (WHO). At WHO, he served as cabinet director under Director-General Gro Harlem Brundtland where he led the development of WHO’s Framework Convention on Tobacco Control and the Global Strategy on Diet and Physical Activity.

Click here for the complete list of speakers

Courses

DAY 1 - INTRODUCTION TO THE NATIONAL AND INTERNATIONAL REGULATION OF THE FOOD AND DRUG SUPPLY

Session 1 – Welcome and Introductions

Speakers: Oscar Cabrera (Executive Director, O’Neill Institute), “The O’Neill Institute’s Role in Closing Educational and Regulatory Gaps in a Globalizing Environment of Food Production and Drug Manufacturing”; Sam Halabi, (O’Neill Institute) “Welcome”


Session 2 – Challenges and Opportunities in Changing Food and Drug Supply Chains, Research, Public Health and Regulation

Speakers: Dr. Jesse L. Goodman (Georgetown University Center on Medical Product Access, Safety and Stewardship); Sandra Eskin (The Pew Charitable Trusts) Moderator: Sam Halabi (O’Neill Institute)


Session 3 – Current Trends in the Architecture and Enforcement of US Federal Food and Drug Law

Speakers: Professor Joseph A. Page (Georgetown University); Ariel Glasner (Blank Rome LLP); Jodi Avergun (Cadwalader Wickersham and Taft)
Moderator: Aliza Glasner (O’Neill Institute)


Session 4 – Roundtable on Non-US Approaches to Food and Drug Regulation

Moderator: Sam Halabi (O'Neill Institute)


DAY 2 - BEST PRACTICES

Session 1 – Before the FDA Comes Knocking: Current Good Manufacturing Practices and Dealing with FDA Enforcement Actions

Speakers: Jennifer Zachary (Covington and Burling, LLP); Marc Scheineson (Alston and Bird, LLP) Moderator: Sam Halabi (O’Neill Institute)


Session 2 – Food and Drug Regulation in Shared Regulatory Space: Perspectives from the Federal Trade Commission and Environmental Protection Agency

Speakers: David Vladeck (Georgetown University and Former Director of FTC’s Bureau of Consumer Protection); Lisa Heinzerling (Georgetown University and Former Associate Administrator, EPA Office of Policy
Moderator: Sam Halabi (O’Neill Institute)


Session 3 – Best Practices in Regulatory Compliance and the Interface of Manufacturing, Supply Chains and Standards in China

Speakers: Philip Chen (Office of the US Trade Representative), Gordon Schatz (Reed Smith); Ed Zhao (US Pharmacopeial Convention)
Moderator: Susan Roosevelt Weld (Executive Director, Law Asia Leadership, Georgetown University)


Session 4 – Keynote: Dr. Margaret Hamburg, Commissioner, US FDA

Speaker: Dr. Margaret Hamburg (FDA)
Moderator: John Monahan (Georgetown University)


DAY 3 - PUBLIC SECTOR AND PRIVATE SECTOR REGULATORY STRATEGIES

Session 1 – The Balance Between Regulation and Private Sector Initiative in Securing Healthy Sustainable Food

Speaker: Derek Yach (The Vitality Group; Former Senior Vice President of Global Health and Agriculture Policy at PepsiCo; Former Representative of the Director-General of the World Health Organization)


Session 2 – The FDA’s Global Regulatory Activities 

Speakers: Doug Stearn (FDA); Jennifer Devine (FDA)


Session 3 – Counterfeit Medicines, Safe Online Pharmacies and Detection Technologies

Speakers: Jeff Gren (US Department of Commerce, Office of Health and Consumer Goods); Ilisa Bernstein (FDA)
Moderator: Michele Forzley (O’Neill Institute)


Session 4 – Comparative EU and US Approaches to Food and Drug Regulation

Speakers: Ben Haas (Latham and Watkins, LLP); Alberto Alemanno (HEC Paris and O’Neill Institute)(via video-link); Sabine Haubenreisser (European Medicines Agency)


DAY 4 - TRADE AND INVESTMENT LIMITS ON REGULATORY MEASURES

Session 1 – Trade, Investment and Food and Drug Regulatory Measures: Basic Principles of Trade Policy and Law

Speaker: Benn McGrady (O’Neill Institute)


Session 2 – Regulatory Harmonization, Cooperation and Memoranda of Understanding

Speakers: Michele Forzley (O’Neill Institute); Katherine Cooper (FDA); James Fitzgerald (Pan American Health Organization)


Session 3 – The Codex Alimentarius and the Food Safety ModernizationAct

Speakers: Chris Waldrop (Consumer Federation of America); Sharon Mayl (US FDA); Aliza Glasner (O’Neill Institute)
Moderator: Sam Halabi (O’Neill Institute)


Session 4 – Food and Drug Regulation in India: Priorities for the New Government

Speaker: Vince H. Suneja (Chief Executive Officer, TwoFour Insight Group, LLC; Former First Secretary, Market Access & Compliance Attaché at the U.S. Embassy in New Delhi, India)


DAY 5 - NATIONAL AND INTERNATIONAL FOOD AND DRUG REGULATION: THE OPEN QUESTIONS

Session 1 – Necessary Investments in Regulatory Infrastructure and Working with Governments Lacking Regulatory Capacity

Speakers: John Monahan (Georgetown University and U.S. State Department); Parth Chanda (Pfizer Pharmaceuticals); Bruce Gellin (HHS Deputy Assistant Secretary for Health; Director, National Vaccine Program Office) 
Moderator: Sam Halabi (O’Neill Institute)


Session 2 – The Affordable Care Act and Congressional Priorities for Food and Drug Regulation

Speakers: Tim Westmoreland (Georgetown University); Prof. Samuel R. Wiseman (Florida State University)

Session 3  Lunchtime Talk and Open Forum for Unanswered Questions

Click here for more information about offered courses

Copyright © 2014 The O’Neill Institute for National and Global Health Law at Georgetown University. All rights reserved.

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