EMEA Work Plans

30/01/07 Work Plan for the Safety Working Party (SWP) - 2007-2008
30/01/07 Work Plan for the Gene Therapy Working Party (GTWP) - 2007-08
30/01/07 Work Plan for the Pharmacogenetics Working Party 2007
30/01/07 Work Plan for the Biosimilar Medicinal Products Working Party (BMWP) 2007

http://www.emea.europa.eu/pdfs/human/swp/15242006en.pdf
http://www.emea.europa.eu/pdfs/human/genetherapy/16071506en.pdf
http://www.emea.europa.eu/pdfs/human/pharmacogenetics/5124106en.pdf
http://www.emea.europa.eu/pdfs/human/biosimilar/21292306en.pdf

Presentation slides of "The 2006 Symposium on APEC Network on Pharmaceutical Regulatory Science"

「2006年APEC医薬品等ﾚｷﾞｭﾗﾄﾘｰ・ｻｲｴﾝｽ・ﾈｯﾄﾜｰｸ ｼﾝﾎﾟｼﾞｳﾑ」のﾎｰﾑﾍﾟｰｼﾞに講演資料を掲載しました。Presentation slides of "The 2006 Symposium on APEC Network on Pharmaceutical Regulatory Science" Now Published.
http://www.pmda.go.jp/apec2006ph/jp/agenda.html

MHLW 治験問題検討委員会中間報告 英訳

昨年9月に統合機構から治験問題検討委員会中間報告が出ていましたが、昨日付けで英訳も掲載されました。
http://www.pmda.go.jp/pdf/clinical.pdf

日本語版報告書：http://www.pmda.go.jp/pdf/181003data-siryo4-2.pdf
議事次第：http://www.pmda.go.jp/hyougikai/H181003gijishidai.html
議事録：http://www.pmda.go.jp/pdf/H181003gijiroku.pdf

EMEA Reflection Paper on the use of Genomics in Cardiovascular Clinical Trials

09/01/07
Reflection Paper on the use of Genomics in Cardiovascular Clinical Trials

FDA: Draft Guidance for Industry: E15 Terminology in Pharmacogenomics

Posted on 8 Jan 2007:
Draft Guidance for Industry: E15 Terminology in Pharmacogenomics