Draft Guidance for Industry Good Pharmacovigilance Practices and Pharmacoepidemiology Assessment

Draft Guidance for Industry Good Pharmacovigilance Practices and Pharmacoepidemiology Assessment

Guidelines for good pharmacoepidemiology practices (GPP).

Pharmacoepidemiologic studies provide valuable information about the health effects of healthcare products. The ISPE Guidelines for Good Pharmacoepidemiology Practices (GPP) are intended to assist investigators with issues pertaining to the planning, conduct, and evaluation of pharmacoepidemiologic research. The first revision, in 2004 revised and superseded the Guidelines for Good Epidemiologi...

Strengthening standards, transparency, and collaboration to support medicine evaluation: Ten years of the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP)

The European Medicines Agency (EMA) has the responsibility for the scientific evaluation, supervision, and safety monitoring of medicines in the European Union (EU) to ensure that their benefits outweigh their risks. While the roots of medicines' safety monitoring lie in the development of mechanisms for spontaneous reporting of suspected adverse reactions by health‐care professionals and patie...

Practice-Based Research Networks: Integrating Clinical Data for Improved Pharmacoepidemiology

Pharmacovigilance is concerned with the detection, assessment, understanding, and prevention of adverse reactions to medicines. It is helpful to prevent undesired harm sustained by the patient due to inappropriate or unsafe use of medicinal agents. As the use of drugs and polypharmacy increase in prevalence, pharmacovigilance gains relevance and momentum. Practice-based research networks have t...

The European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP) Guide on Methodological Standards in Pharmacoepidemiology (Revision 1)