「原資料」に求められるもの ALCOAの原則

信頼性の高い原資料 （ALCOA （CCEA）） FDA. EMA. Guidance for Industry Computerized Systems Used in Clinical Investigations, May 2007(FDA)

  System, Used, Clinical, Investigation, Computerized, Computerized systems used in clinical investigations

EU Module 1 eCTD Specification - Europa

CR 20110614 1.4.3 17 December 2012 EFPIA EFPIA changes, added PDF 1.5, 1.6, edited file allowed formats, added common for CP, adjustments to agency codes

  Specification, Module, Ectd, Efpia, Eu module 1 ectd specification, Efpia efpia

EI Risk Assessment - European Medicines Agency

www.efpia.eu . 2. Overview . Using the principles outlined in ICH Q3D and training modules we will: • Present a series of risk assessments based on actual products.

  Assessment, Risks, Ei risk assessment, Efpia

Drug Pricing Reform Proposals Presented to Date …

PhRMA and EFPIA will continue to strive for pricing policy revisions that ensure that the drug budget remains well controlled but at the same time fully support the

  Date, Drug, Proposal, Reform, Pricing, Presented, Efpia, Drug pricing reform proposals presented to date

EFPIA Japan MSL ガイドライン

EFPIA Japan MSL ガイドライン Ver.01 p. 2 づいて活動が行われたりするなど、公平性や透明性の確保が困難な場合があった。

  Efpia

Version 1.4.1 November 2011 - Europa

In line with the general principles of the ICH eCTD Specification, it is intended that XML will eventually become the sole submission format …

  2011, November, November 2011

Unique country Country of Donations and Related …

Sponsorship agreements with HCOs/third parties appointed by HCOs to manage an Event Registration fees Travel & accomadation Fees Related expenses