for MedDRA Implementation and Versioning for MSSO’s Recommendations Clinical Trials Transition Date for the Next MedDRA Version Production SMQ spreadsheet* List of system tools that support SMQs * Requires user ID and password to access The following document can be found on the ICH website (): ICH E2E: Pharmacovigilance Planning Membership of the ICH Points to Consider Working Group Current members of the ICH Points to Consider Working Group Affiliation Member Maria Luisa Casini Commission of the European Communities Kavita Chadda Hilary Vass* European Federation of Pharmaceutical Industries and Associations Christina Winter† Valérie Bergeron Health Canada Lynn Macdonald Yutaka Nagao Japanese Maintenance Organization Kazuyuki Sekiguchi Mitsuru Takano Yo Tanaka Japan Pharmaceutical Manufacturers Association Hitomi Takeshita MedDRA MSSO Judy Harrison Daisuke Inoue Ministry of Health, Labour and Miki Ohta Welfare/Pharmaceuticals and Medical Daisuke Sato Devices Agency Yasuko Inokuma
MSSO’s Recommendations for MedDRA Implementation and Versioning for Clinical Trials Transition Date for the Next MedDRA Version Production SMQ spreadsheet* List of system tools that support SMQs * Requires user ID and password to access The following document can be found on the ICH website (): ICH E2E: Pharmacovigilance Planning 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 Kavita Chadda European Federation of Pharmaceutical Industries and Associations Hilary Vass* Christina Winter† Health Canada Valérie Bergeron Lynn Macdonald Japanese Maintenance Organization Yutaka Nagao Kazuyuki Sekiguchi Mitsuru Takano Japan Pharmaceutical Manufacturers Association Yo Tanaka Hitomi Takeshita MedDRA MSSO Judy Harrison Ministry of Health, Labour and Welfare/Pharmaceuticals and Medical Devices Agency Daisuke Inoue Miki Ohta Daisuke Sato Yasuko Inokuma
9610-1900_datretptc_r3_11_mar2016_0.docx