PhRMA Adaptive Designs Workshop

PhRMA Adaptive Designs Workshop
Opportunities, Challenges and Scope in Drug Development November 13-14, 2006
http://www.innovation.org/index.cfm/NewsCenter/Briefings/Adaptive_Designs_Workshop

MHLW 次期治験活性化計画策定に係る検討会

2006/12/15掲載
[審]　次期治験活性化計画策定に係る検討会第６回資料
[審]　次期治験活性化計画策定に係る検討会第５回議事録

20061213 Clinical Evaluation of New Vaccines

13/12/06
Clinical Evaluation of New Vaccines- Guideline- Annex

EMEA 臨床評価ガイドラインがいくつか出ました

12/12/06
Draft Guideline on the development of new medicinal products for the treatment of ulcerative colitis - Deadline for comments 31 May 2007
12/12/06
Questions and Answers on Guideline: Clinical investigation of corticosteroids intended for use on the skin
12/12/06
Guideline on the Evaluation of New Medicinal Products in the Treatment of Primary Osteoporosis- Overview of Comments received on Draft Guideline on the Evaluation of New Medicinal Products in the Treatment of Primary Osteoporosis
12/12/06
Guideline on Clinical Investigation of Medicinal Products for the Treatment of Multiple Sclerosis- Overview of Comments received on Draft Guidelinle on Multiple Sclerosis
12/12/06
Draft Guideline on Clinical Investigation of Medicinal Products for Prophylaxis of High Intra- and Post-operative Venous Thromboembolic Risk - Deadline for comments 31 May 2007

PMDA 運営評議会のリンク

PMDA 外国機関報告書の邦訳

外国機関報告書の邦訳
　
新しい医薬品・医療機器のためのクリティカル・パス上に存在する課題と機会（米FDA、2004年3月）
　
クリティカル・パス計画報告書－医薬品・医療機器の研究開発に関するヒント－（米FDA、2006年3月）
　
欧州医薬品庁2010年へ向けてのロードマップ：将来に向けた基盤整備（欧州医薬品庁（EMEA）、2005年3月）

20061204 Guideline on the use of statistical signal detection methods in the EudraVigilance data analysis system

04/12/06 Guideline on the use of statistical signal detection methods in the EudraVigilance data analysis system (Deadline for comments 16 May 2007) http://www.emea.europa.eu/pdfs/human/phvwp/10646406en.pdf