Mitsuru Takano Reiji Tezuka Yo Tanaka Japan Pharmaceutical Manufacturers Association Hitomi Takeshita MedDRA MSSO Judy Harrison Yuhei Fukuta Ministry of Health, Labour and Miki Ohta Welfare/Pharmaceuticals and Medical Daisuke Sato Devices Agency Makiko Isozaki Milbhor D’Silva Pharmaceutical Research and Manufacturers of America JoAnn Medbery Sonja Brajovic# US Food and Drug Administration Christopher Breder YuBin Lee Ministry of Food and Drug Safety, Korea Kyung-Eun Yoon * Current Rapporteur # Regulatory Chair Former Rapporteur † 6.2.2 Former members of the ICH Points to Consider Working Group The table of former members was replaced and updated as follows: Affiliation Member Dolores Montero Commission of the European Carmen Kreft-Jais Communities Morell David European Federation of Barry Hammond†; Reinhard Pharmaceutical Industries and Fescharek† Associations Alison Bennett, Heather Morrison; Health Canada Michelle Séguin; Heather Sutcliffe; Bill Wilson
Mitsuru Takano Reiji Tezuka Japan Pharmaceutical Manufacturers Association Yo Tanaka Hitomi Takeshita MedDRA MSSO Judy Harrison Ministry of Health, Labour and Welfare/Pharmaceuticals and Medical Devices Agency Yuhei Fukuta Miki Ohta Daisuke Sato Makiko Isozaki Pharmaceutical Research and Manufacturers of America Milbhor D’Silva JoAnn Medbery US Food and Drug Administration Sonja Brajovic# Christopher Breder Ministry of Food and Drug Safety, Korea YuBin Lee Kyung-Eun Yoon * Current Rapporteur # Regulatory Chair † Former Rapporteur 6.2.2 Former members of the ICH Points to Consider Working Group The table of former members was replaced and updated as follows: Affiliation Member Commission of the European Communities Dolores Montero Carmen Kreft-Jais Morell David European Federation of Pharmaceutical Industries and Associations Barry Hammond†; Reinhard Fescharek† Health Canada Alison Bennett, Heather Morrison; Michelle Séguin; Heather Sutcliffe; Bill Wilson
dataretptc_r3.8soc_sep2014.docx