Pharmacovigilance is defined by WHO as ‘The science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problems’. The process is one of managing risk associated with medicinal products, in an effort to promote their safe and effective use by prescribers and patients.
We at GMP Compliance with our associates are experts in providing in pharmacovigilance services to assist and support Marketing Authorisation Holders (MAH), of pharmaceutical product licences, in their efforts to remain compliant with EU regulatory requirements (Regulation 1235/2010 and Directive 2010/84/EU) the deadline for which implementing ended on 21 July 2012.
Some of our key services we provide along with our associates are:
- Signal Detection
- PV Systems Development and Implementation
- PV Audits
- Implementation of EU PV legislation
- Report writing
- PV inspection support
- Regulatory support
For companies who would be looking for people to fit to key roles we have on offer
- PV physician
- PV specialist