News

21 July 2008 NEW

Transitional Committee Website

http://www.transitionalcommittee.com/

21 July 2008 NEW

EU harmonised birth dates

The final version of the additional list of EU harmonised birth dates (HBDs) and harmonised PSUR data lock points (DLPs) for well-known substances approved in the EU before December 1976 has now been posted on the HMA website. The HBDs and harmonised DLPs for substances approved since then along with their allocated RMS are also available at this site.

16 July 2008 NEW

PIPA 2008 Salary Survey

The PIPA 2008 Salary Survey has now been released and is available to PIPA members in the Members' area of the website.

16 June 2008

Public consultation (MLX 350): Amendments to the Medicines for Human Use (Marketing Authorisations, etc.) Regulations 1994 to clarify pharmacovigilance reporting requirements

MLX350 seeks your views on amendments to the Medicines for Human Use (Marketing Authorisations, etc.) Regulations 1994 to clarify pharmacovigilance reporting requirements.

16 June 2008

MHRA - Common Inspection Findings

The MHRA has recently published an overview of some common inspection findings and current areas of concern that they have identified during recent inspections. Click on: Common Inspection Findings. Alternatively, go to their Good Pharmacovigilance Practice: News site

16 June 2008

Systematic review: Incidence and nature of in-hospital adverse events

This systematic review attempted to provide insight into the overall incidence, preventability and outcome of adverse events occurring in hospital, and also to add information about location, provider and type of events

15 June 2008

FDA rolls out system to link electronic databases for pharmacovigilance

US health officials have finally unveiled details of the FDA's plan to use the massive database containing information on around 25 million people who get their drugs through Medicare's drug benefit programme, as part of an effort to track postmarket adverse events. Medicare is the US insurance programme for the elderly and disabled.

8 June 2008

Adverse effect information in patient information leaflets in UK is inadequate

According to research published in Drug Safety, patient need on adverse effect information is not being met in terms of the provision of usable information about the likelihood of adverse effects.