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Day 1
03 December 2024
Collaboration and worksharing to bring innovation to patients
07:30 - 10:30 CET / 17:30 - 20:30 AEDT
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Empowering patient voices: integrating patient perspectives in regulatory affairs
07:30 - 08:00 CET / 17:30 - 18:00 AEDT
Session objectives:
Underline the role of patient perspectives in shaping regulatory policies.
Explore best practices and capacity-building examples across the Asia region.
Speakers
Moderator
Paloma Tejada
Associate Director, Alliance Building, IFPMA
Panelists
Karen Alparce-Villanueva
President, Philippine Alliance of Patient Organizations (PAPO)
Julie Cini
Director, Advocacy Beyond Borders / SMA Australia
Edmund Lau
Committee Member, World Patients Alliance
Keynote sessions
08:00 - 09:00 CET / 18:00 - 19:00 AEDT
Speakers
Speaker
Felicity Jameson
Director, Regulatory Strengthening Section, International Regulatory Branch, Medicines Regulation Division, Therapeutic Goods Administration (TGA), Australia
Marie Valentin
Team Lead, Facilitated Product Introduction Regulation and Safety Unit [REG] Regulation and Prequalification Department [RPQ], World Health Organization
Access Consortium
09:00 - 10:30 CET / 19:00 - 20:30 AEDT
Session objectives:
Share high-level overview of Facilitated Product Introduction & TGA’s Regulatory Strengthening Program
Provide platform for greater understanding of ACCESS Consortium (how it works, future plans, industry experience, etc.)
Speakers
Presenter
Leonard Both
Swissmedic ATMP Unit, SMZ
Panelists
Michelle Cheng
Regional Therapeutic Area Head, Neuroscience, Eyecare & Specialty, JAPAC, Regulatory Intercontinental , AbbVie
Helen Critchley
Country Regulatory Head – Australia & NZ, Sanofi
Freddie Foo
CMC Team Lead / Regulatory Consultant, Health Sciences Authority (HSA)
Joel Raffel
Leading Senior Medical Assessor; MHRA Access Consortium Representative, Medicines and Healthcare products Regulatory Agency (MHRA)
Michael Wiseman
Assistant Secretary, International Regulatory Branch, Therapeutic Goods Administration (TGA), Australia