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