20080620 Draft guideline on the clinical development of medicinal products for the treatment of cystic fibrosis

20/06/08
Draft guideline on the clinical development of medicinal products for the treatment of cystic fibrosis

20080620 EMEA Concept paper Note for Guidance on Clinical Investigation of Medicinal Products in the Treatment of DIabetes Mellitus

20/06/08
Concept paper on the need for revision of the Note for Guidance on Clinical Investigation of Medicinal Products in the Treatment of Diabetes Mellitus

20080620 EMEA Concept paper Note for Guidance on Clinical Investigation of Medicinal Products in the Treatment of Lipid Disorders

20/06/08
Concept paper on the need for revision of (CHMP) Note for Guidance on Clinical Investigation of Medicinal Products in the Treatment of Lipid Disorders

20080610 PMDA 平成20事業年度第1回運営評議会審査・安全業務委員会会議資料

平成20事業年度第1回運営評議会審査・安全業務委員会会議資料の掲載について
http://www.pmda.go.jp/guide/hyougikai/shinsaanzen.html

議事次第 （平成20年度第1回審査・安全業務委員会）
平成20年6月10日
開会
理事長挨拶
議題 （１）平成１９年度業務報告について
（２）平成２０年度計画等について
（３）広報業務改革の実施について
（４）企業出身者の就業状況の報告について
（５）その他
閉会
　※ファイルのサイズが大きいので、ダウンロードしてご覧下さい。
資料1　 平成19事業年度業務報告 (PDF形式)　　　　　　　　
＜審査等業務・安全対策業務関係＞
資料2-1　 平成20年度計画の概要 (PDF形式)
資料2-2　 中期目標・中期計画・19年度計画・20年度計画対比表 (PDF形式)
資料2-3　 平成20事業年度予算説明資料 (PDF形式) 資料3　 PMDA広報戦略事務局案 (PDF形式)
資料4-1　 独立行政法人医薬品医療機器総合機構職員の業務の従事制限に関する実施細則（平成17年細則第1号）附則第3項の報告について (PDF形式)
資料4-2　 企業出身者の就業状況の報告について (PDF形式)
資料5　 独立行政法人医薬品医療機器総合機構における企業出身者の就業制限ルールの遵守状況に関する監査結果報告 (PDF形式)
資料6　 業務・システム最適化計画 (PDF形式)
参考資料1　 審査・安全業務委員会委員名簿 (PDF形式)
参考資料2　 新医薬品承認審査実務に関わる審査員のための留意事項 (PDF形式)
審議参加に関する遵守事項 (PDF形式)

20080522 MHLW 第８回 厚生科学審議会科学技術部会臨床研究の倫理指針に関する専門委員会

http://www.mhlw.go.jp/shingi/2008/05/s0522-3.html

20080604 Guideline on Human cell-based medicinal products

04/06/08
Guideline on Human cell-based medicinal products
http://www.emea.europa.eu/pdfs/human/cpwp/41086906enfin.pdf

20080603 US: 2008The ONC-Coordinated Federal Health IT Strategic Plan: 2008-2012

EHR related:
http://www.hhs.gov/healthit/resources/reports.html

June 3, 2008The ONC-Coordinated Federal Health IT Strategic Plan: 2008-2012
Full Report (PDF) (679KB)
Synopsis (PDF) (501KB)

20080530 「臨床研究に関する倫理指針」の改正案に関する意見募集

http://search.e-gov.go.jp/servlet/Public?CLASSNAME=Pcm1010&BID=495080030&OBJCD=&GROUP=

20080522 日本学術会議提言：日本における臨床治験の問題点と今後の対策

2008/5/22
日本における臨床治験の問題点と今後の対策
臨床医学委員会・薬学委員会合同 臨床試験・治験推進分科会

http://www.scj.go.jp/ja/info/kohyo/pdf/kohyo-20-g57-2.pdf

2007103 EMEA EMEA Operation of the Clinical Trials Directive (Directive 2001/20/EC) and Perspectives for the Future

October
3
Operation of the Clinical Trials Directive (Directive 2001/20/EC) and Perspectives for the Future - A joint conference of the European Commission and the European Medicines Agency*


Operation of the Clinical Trials Directive (Directive 2001/20/EC) and Perspectives for the Future - A joint conference of the European Commission and the European Medicines Agency
3 October 2007EMEA, Canary Wharf, London, UK
Please note that the size of some of the documents listed here exceed 50 pages. You are therefore advised to be selective about which sections or pages you wish to print.
Main report
Conference Report (main report, conference programme and list of attendees)
Presentations
Download either all presentations combined [PDF 6.73MB] or individual presentations:
Thomas Lönngren
Alan Morrison (session 2)
Monique Podoor
Hartmut Krafft
Michael Fuchs
Fernand Sauer
Gaby Danan
Stefan Bielack
Brian Davis
Pierre Henri Bertoye
Dominique Sprumont
Rory Collins
Silvio Garattini
Jacques Demotes-Mainard (session 4)
John Poland
Dagmar Chase
Nikos Dedes
Alan Morrison (session 4)
Mats Ericson
Ritva Halila
Chantal Bélorgey
Stefan Bielack (session 5)
Jacques Demotes-Mainard (session 5)
François Chapuis
Octavi Quintana Trias
Written submissions
Download either all submissions combined [PDF 1.24MB] or individual submissions:
ACRO - Association of Clinical Research Organizations
AFSSAPS - French Health Products Safety Agency
Association of the European Self-Medication Industry
Cancer Research UK
CPP - France
CTFG - Clinical Trials Facilitation Group (Belorgey)
CTFG - Clinical Trials Facilitation Group (Davis)
CTFG - Clinical Trials Facilitation Group (Krafft)
Czech Republic, State Institute for Drug Control
ECRIN, EORTC, ESF, CPI, INSERM, VISEAR, ECISM
EBMT - European Group for Blood and Marrow Transplantation
EC - Directorate General for Research and Technology Development
EFGCP - European Forum for Good Clinical Practice
EFPIA - European Federation of Pharmaceutical Industries and Associations
EGAN - European Genetic Allliance’s Network
ESDP - European Society for Developmental, Perinatal and Paediatric Pharmacology
Ethics Committee Medica University of Vienna
EUCROF - European CRO Federation
EULAR - European League Against Rheumatism
EUREC - European Network of Research Ethics Committees
EuropaBio
European Association of Nuclear Medicine
European Hematology Association
Finland - Ethics Committee
Finland NCA
GCP IWG - GCP inspections working group
Good Clinical Practice Alliance Europe
HCP WP - EMEA/CHMP Working Group with Healthcare Professionals’ Organisations (Youle)
International Society for Pharmaceutical Engineering
Irish Platform for Patients' Organisations
Italian Medicines Agency
Mario Negri Institute
MCRN - Medicines for Children Research Network
PAED-net - Paediatric-Network Germany
EMEA Human Scientific Committees Working Party with Patients’ and Consumers’ Organisation (PCWP)
Poland - Ministry of Health
PPTA - Plasma Protein Therapeutics Association
SIOP Europe - Société Internationale d’Oncologie Pédiatrique
Spain - Agencia Española de Medicamentos y Productos Sanitarios
Task Force in Europe for Drug Development for the Young
Spontaneous submissions
CNCP Conference National of committees of protection of persons (REC)
Directive and Research Governance in Europe
European Cancer Patient Coalition (ECPC)
GCP - Records Managers Association
HCP WP - EMEA/CHMP Working Group with Healthcare Professionals’ Organisations (HCP WG) (Sampaio)
Novartis
Biographies
Biographies of chairs, speakers and panellists
Questions/comments received after the conference
Questions/comments received after the conference

20080530 EMEA-EFPIA adaptive design workshop 20071214 presentations

30/05/08
Presentations from the EMEA-EFPIA workshop on adaptive designs in confirmatory clinical trials (14 December 2007)