Membership of the ICH Points to Consider Working Group Current members of the ICH Points to Consider Working Group Affiliation Member Commission of the European Communities Maria Luisa Casini Sarah Vaughan European Federation of Pharmaceutical Industries and Associations Hilary Vass* Christina Winter† Health Canada Polina Ostrovsky Lynn Macdonald Japanese Maintenance Organization Yutaka Nagao Kazuyuki Sekiguchi 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
Former members of the ICH Points to Consider Working Group 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 Japanese Maintenance Organization Osamu Handa; Akemi Ishikawa; Yasuo Sakurai; Yuki Tada Japan Pharmaceutical Manufacturers Association Takayoshi Ichikawa; Akemi Ishikawa; Satoru Mori; Yasuo Sakurai; Kunikazu Yokoi MedDRA MSSO JoAnn Medbery; Patricia Mozzicato Ministry of Health, Labour and Welfare/Pharmaceuticals and Medical Devices Agency Tamaki Fushimi; Wakako Horiki; Sonoko Ishihara; Kazuhiro Kemmotsu; Tatsuo Kishi; Chie Kojima; Emiko Kondo; Hideyuki Kondou; Kemji Kuramochi; Tetsuya Kusakabe; Kaori Nomura; Izumi Oba; Shinichi Okamura; Yoshihiko Sano; Nogusa Takahara; Kenichi Tamiya; Daisuke Tanaka; Shinichi Watanabe; Takashi Yasukawa; Go Yamamoto; Manabu Yamamoto; Nobuhiro Yamamoto Pharmaceutical Research and Manufacturers of America David Goldsmith; Sidney Kahn; Kleckner; Susan M. Lorenski; Margaret M. Westland† US Food and Drug Administration Miles Braun; Andrea Feight; John (Jake) Kelsey†; Brad Leissa; Toni Piazza-Hepp † Former Rapporteur
Figures OTHER TERMINOLOGY PREFERRED TERMS No. of EVENTS MedDRA Version 17.1 PREFERRED TERMS No. of EVENTS Infection 15 Upper respiratory tract infection Nasopharyngitis Infection Lower respiratory tract infection Skin infection 7 2 1 4 1 Abdominal pain 9 Abdominal pain Abdominal pain upper Abdominal tenderness 4 3 2 Accidental injury 4 Injury Skin laceration Ligament sprain Back injury 1 1 1 1 Figure 1 – How data coded to a single concept from another terminology may be expressed by several PTs in MedDRA OTHER TERMINOLOGY MedDRA Version 17.1 Reported Event (% subjects) Coded Term (% subjects) Body System/SOC (% subjects) PT (% subjects) SOC (% subjects) Hyperglycaemia (4.1) Hyperglycaemia (10.5) Metabolism & nutritional disorders (10.5) Hyperglycaemia (4.1) Metabolism and nutrition disorders (4.1) Increased blood sugar (2.7) Glucose increased (2.2) Blood glucose high (1.0) Blood glucose increased (6.4) Investigations (6.4) Increasing glucoses (0.5) Figure 2 – Multiple MedDRA terms may be used to code similar medical conditions included in a “disorder SOC”; associated laboratory findings are in SOC Investigations