ISPE Risk Management

Publications/Guidance

Region: EMEA

• DRAFT Guideline on Risk Management for Medicinal Products for Human Use. Deadline for comments October 5, 2005.

Region: ICH

• November 18, 2004. The International Conference on Harmonisation of Technical Requirements for registration of Pharmaceuticals for Human Use, ICH Harmonized Tripartite Guideline on Pharmacovigilance Planning E2E was recommended for Adoption at Step 4 of the ICH Process by the ICH Steering Committee

Region: European Union

• December 2004. The E2E Pharmacovigilance Planning (PVP) — Note for Guidance on Planning Pharmacovigilance Activities (Step 4) was adopted at the 7th CHMP meeting in December as CPMP/ICH/5716/03 with an implementation date of June 2005

Region: United States of America

• March 24, 2005. FDA issued the three final guidance documents to help develop new ways and improve methods to assess and monitor the risks associated with drugs and biological products in clinical development and general use.
  • Guidance for Industry: Premarketing Risk Assessment
  • Guidance for Industry: Development and Use of Risk Minimization Action Plans
  • Guidance for Industry:Good Pharmacovigilance Practices and Pharmacoepidemiologic Assessment

Meetings

ISPE will be offering the Introduction to Therapeutic Risk Management course at 8:30am, Sunday, August 19, 2007, in conjunction with the ICPE 2007, August 19-22, 2007, Quebec City Convention Centre. Click here for more information on ICPE 2007.