Pharmacovigilance Flashcards
1
Q
Describe 5 functions of Medicines & Healthcare products Regulatory Agency
A
- regulate medicines
- regulate medical devices
- regulate blood components for transfusion in the UK
- help to educate the public and healthcare professionals about the risks and benefits of medicines, medical devices and blood components, leading to safer and more effective use
- support innovation through scientific research and development that’s beneficial to public health
2
Q
Describe 5 functions of European Medicines Agency
A
- Protect public and animal health in 28 EU Member States, as well as the countries of the European Economic Area, by ensuring that all medicines available on the EU market are safe, effective and of high quality.
- Evaluate applications for marketing authorisation
- The Agency publishes clear and impartial information about medicines and their approved uses.
- EMA continuously monitors and supervises the safety of medicines that have been authorised in the EU, to ensure that their benefits outweigh their risks.
- EMA also plays a role in supporting research and innovation in the pharmaceutical sector, and promotes innovation and development of new medicines by European micro-, small- and medium-sized-enterprises.
3
Q
Describe 5 functions of ENCEPP (The European Network of Centres for Pharmacoepidemiology and Pharmacovigilance)
A
- Facilitating the conduct of high quality, multi-centre, independent post-authorisation studies (PAS) with a focus on observational research;
- Bringing together expertise and resources in pharmacoepidemiology and pharmacovigilance across Europe and providing a platform for collaborations;
- Developing and maintaining methodological standards and governance principles for research in pharmacovigilance and pharmacoepidemiology.
- The ENCePP Code of Conduct provides a set of rules and principles for pharmacoepidemiology and pharmacovigilance studies to promote transparency and scientific independence throughout the research process.
- ENCePP Checklist for Study Protocols: a tool to promote the quality of studies
