ISPE Risk Management

Publications/Guidance

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

• 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

• 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

• 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