20090324 PMDA 新医薬品の承認審査における申請者と医薬品医療機器総合機構の情報共有等について

http://www.pmda.go.jp/topics/file/h210323kohyo.pdf

20090316 PMDA 運営評議会資料

平成20事業年度第4回運営評議会
議事次第（平成20事業年度第4回運営評議会）
平成21年3月16日（月）10時00分～　

開会
理事長挨拶
議題
(1) 第2期中期計画について
(2) 平成21年度計画（案）について
(3) 平成21事業年度予算（案）について
(4) 企業出身者の就業状況の報告について
(5) 専門協議の実施に関する各専門委員における寄附金等の受取状況について
(6) 平成20事業年度予算の変更について
(7) その他
閉会
http://www.pmda.go.jp/guide/hyougikai/20/h210316gijishidai.html

20090317 EMEA 2008 Public Status Report on the Implementation of the European Risk Management Strategy

statistical signal detection
http://www.emea.europa.eu/pdfs/human/phv/4355609en.pdf

20090426 FDA/DIA Statistics Forum: Emerging and Strategic Issues in Drug Development: Personalized Medicine and Guidance Update

The 3rd Annual FDA/DIA Statistics Forum: Emerging and Strategic Issues in Drug Development: Personalized Medicine and Guidance Update

http://www.diahome.org/DIAHOME/Education/FindEducationalOffering.aspx?productID=18027&eventType=Meeting

20090313 13/03/09 EMEA/EFPIA 2nd workshop on Adaptive Design in Confirmatory Trials taking place on 2 April 2009, in London

13/03/09 EMEA/EFPIA 2nd workshop on Adaptive Design in Confirmatory Trials taking place on 2 April 2009, in London
- Agenda Rev.
- Registration form New

http://www.emea.europa.eu/pdfs/conferenceflyers/EMEA_EFPIA_02-04-09_Agenda.pdf
http://www.emea.europa.eu/pdfs/conferenceflyers/EMEA_EFPIA_02-04-09_Registration_form.pdf

20090227 EMEA guidance, concept paper, reflection paper

27/02/09 Concept paper on the need for a guideline on the treatment of premenstrual dysphoric disorder (pmdd)
http://www.emea.europa.eu/pdfs/human/ewp/1187709en.pdf

27/02/09 Guideline on clinical development of fixed combination medicinal products
- Overview of comments received on above draft guideline
http://www.emea.europa.eu/pdfs/human/ewp/024095enfin.pdf
http://www.emea.europa.eu/pdfs/human/ewp/53306608en.pdf

27/02/09 Concept paper on the need for revision of the points to consider on clinical investigation of medicinal products in the chronic treatment of patients with chronic obstructive pulmonary disease (copd)
http://www.emea.europa.eu/pdfs/human/ewp/819709en.pdf

27/02/09 Concept paper on the need for revision of the note for guidance on evaluation of medicinal products indicated for treatment of bacterial infections
http://www.emea.europa.eu/pdfs/human/ewp/43563508en.pdf

27/02/09 Concept paper on the need for a guideline on the evaluation of drugs for the treatment of gastroesophageal reflux disease (gerd)
http://www.emea.europa.eu/pdfs/human/ewp/1583909en.pdf

27/02/09 Reflection paper on the extrapolation of results from clinical studies conducted outside europe to the eu-population
http://www.emea.europa.eu/pdfs/human/ewp/69270208en.pdf

27/02/09 Guideline on Xenogeneic Cell-based medicinal products
http://www.emea.europa.eu/pdfs/human/cpwp/8350809en.pdf