Global Pharmaceutical Regulation 2017

Preliminary Agenda – Subject to Modification

April 14 (Friday)

Welcome - 9:15 - 9:30 AM

Dean Erin O’Connor

Fred Abbott

Opening remarks and overview

Access to Medicines 9:30 – 11:00 AM

Jorge Bermudez

The changing environment following the release and discussions with the High Level Panel and the Lancet Commission Reports

Jamie Love

Access as a global challenge - strategies for addressing budgetary and other constraints in high and low income markets

Fred Abbott

Competition law, market abuse, parallel trade and other challenges in protecting the public interest in the pharmaceutical sector

Coffee Break 11:00-11:20 AM

The Global Production, Regulatory and Trade Environment 11:20 AM – 12:30 PM (Part 1)

Jicui Dong

Promoting Local Production of Quality Medical Products to Improve Access: WHO Perspective              

Dilip Shah

Confronting shifts in the global trade and investment environment

Lunch 12:30 – 1:30 PM

The Global Production, Regulatory and Trade Environment 1:30 – 2:45 PM (Part 2)

Joe Fortunak

Innovation in production technologies

Xavier Seuba

Regulatory issues surrounding biosimilar products

Coffee Break 2:45 – 3:05 PM

The Innovation Environment 3:05 – 5:30 PM

Nick Drager

The TBVI "Business Model" -- an independent, innovative product development partnership that facilitates the discovery and development of safe and affordable new TB vaccines

Jerry Reichman

Why the Nagoya Protocol Matters to Science and Industry in the United States

Ryan Abbott

Will eliminating regulation spur innovation? The new FDA, off label use, and other elements of deregulation

Xavier Seuba

Innovation and access implications of test data protection for biotechnological drugs


April 15 (Saturday)

The Way Forward - Roundtable Forum (9:30 AM – 12:30 PM)

Strategic planning for implementing recommendations of the High Level Panel, and related alternative recommendations

Strategic planning for moving forward the WHO agenda on local production

Changing governance in international pharmaceutical standard-setting

Strategic planning for pharmaceutical sector inquiries

Proposals for Briefing Paper