Regulating Medicines in a Globalized World The Need for Increased Reliance Among Regulators (2020) / Chapter Skim
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Appendix D: Study Methods
Appendix D: Study Methods
Pages 131-140
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From page 131... ...
, the World Trade Organization, and the World Health Organization. Primary search terms were Mutual Recognition Agreements, MRA, and Reliance.
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From page 132... ...
The overall objectives of the open meetings and information-gathering sessions were to gather input from a wide range of interested parties on their experience with and use of mutual recognition/ reliance agreements and informal practices of recognition/reliance, which allow regulators to use information from their counterparts at foreign drug regulatory agencies, in medicines regulation. All of the information-gathering sessions observed the same general format beginning with opening remarks from the committee chair, followed by remarks from the participant(s)
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From page 133... ...
Food and Drug Administration 11:00 am Break -- Adjourn open session 11:15 am DEBRIEF 12:00 pm WORKING LUNCH: PREPARE FOR OPEN SESSION 2 Lunch available in cafeteria, please return to meeting room for closed session discussion EXPLORE GOALS AND QUESTIONS FOR OPEN 1:00 pm SESSION 2 OPEN SESSION 2 1:30 pm RECONVENE Alastair Wood, Committee Chair
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3:30 pm Adjourn open session Open Meeting 2: Date: July 10, 2019 Location: Bill & Melinda Gates Foundation -- London Office 62 Buckingham Gate, London SW1E 6AJ 8:30 am WELCOME Mary Lou Valdez Associate Commissioner for Diplomacy and Partnership Office of Global Policy and Strategy U.S. Food and Drug Administration 8:35 am OPENING REMARKS Alastair Wood, Committee Chair 9:00 am SESSION I: INFORMATION EXCHANGE AND USE AND SCOPE OF EXCHANGED INFORMATION PRESENTATIONS WITH FACILIATATED DISCUSSIONS National Regulatory Agencies 10-minute remarks, followed by facilitated discussion REGULATORS -- PART 1 9:00 am Alison Cossar (virtual)
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From page 135... ...
Federico Cimini Head of Division Inspectorates Swiss Agency for Therapeutic Products (Swissmedic) 9:30 am Group Discussion 10:00 am BREAK REGULATORS -- PART 2 10:20 am Siu Ping Lam Director, Licensing Division Medicines & Healthcare products Regulatory Agency, United Kingdom Agnes Saint-Raymond and Brendan Cuddy Agnes Saint-Raymond Head of International Affairs Division European Medicines Agency Brendan Cuddy Head of Manufacturing Quality and Supply Chain Integrity European Medicines Agency Dominique De Backer Policy Officer, Pharmaceutical Unit at DG Health and Food Safety European Commission
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From page 136... ...
136 REGULATING MEDICINES IN A GLOBALIZED WORLD John Lynch GMP Inspector and Senior Inspector Health Products Regulatory Authority, Ireland 11:00 am Group Discussion 12:30 pm LUNCH SESSION II: STAKEHOLDER INPUT Input from stakeholder, 15-minute remarks, followed by facilitated discussion 1:30 pm International Organization (virtual) Emer Cooke Director, Regulation of Medicines and Other Health Technologies World Health Organization Facilitated discussion and questions from the committee 2:30 pm Industry Janis Bernat and Rebecca Lumsden Janis Bernat Director, Biotherapeutics and Scientific Affairs International Federation of Pharmaceutical Manufacturers & Associations Rebecca Lumsden Director–EM Regulatory Policy, Pfizer behalf of International Federation of Pharmaceutical On Manufacturers & Associations Facilitated discussion and questions from the committee 3:15 pm Patient Group Kawaldip Sehmi Chief Executive Officer International Alliance of Patients' Organizations Facilitated discussion and questions from the committee 4:00 pm Adjourn open session
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From page 137... ...
: Agnes Saint-Raymond, Head of International Affairs Division, Head of Portfolio Board; Tania Teixeira, European Medicines Agency Liaison Official, U.S. Food and Drug Administration Meeting 3 (Virtual)
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From page 138... ...
: Kaylene Raynes, Director, Applications & Advisory Management; Jane Cook, First Assistant Secretary, Medicines Regulation Division, Prescription Medicines Authorisation; Adrian Bootes, Branch Head, Prescription Medicines Authorisation; Tracey Duffy, First Assistant Secretary, Medical Devices and Product Quality Division; Joe Hlubucek, Senior Policy Officer, International Regulatory Coordination Section
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From page 139... ...
: Chan Chen Leng, Group Director, Health Products Regulation Group (HPRG) ; Jessica Teo, Division Director, Audit and Licensing Branch, HPRG; Agnes Chan, Director, Therapeutic Products Branch, HPRG; Chua Siew Wei, Deputy Director, Stakeholder Engagement Office, HPRG Meeting 13 (In-person)
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