INOPP Forum
PRAC - Pharmacovigilance Risk Assessment Committee
Quote from VigiServe Admin on December 11, 2020, 9:54 AMResponsibility of PRAC
The PRAC is responsible for assessing all aspects of risk management of human medicines, including;
the detection, assessment, minimisation and communication of the risk of adverse reactions, while taking the therapeutic effect of the medicine into account,
design and evaluation of post-authorisation safety studies; and,
pharmacovigilance audit.
The PRAC provides recommendations on questions on pharmacovigilance and risk management systems, including the monitoring of their effectiveness, to the:
CHMP - Committee for Medicinal Products for Human Use for centrally authorised medicines and referral procedures;
CMDh - Coordination Group for Mutual Recognition and Decentralised Procedures for the Human products or the CMDh, on the use of a medicine in the Member States
The EMA secretariat, Management Board and European Commission, as applicable
What is the Composition of PRAC?
The PRAC consists of:
1. A Chair;
2. one member and one alternate member appointed by each of the EU Member States;
3. one member and one alternate member appointed by each of the EEA-EFTA States;
4. six members appointed by the European Commission,
5. one member and one alternate member appointed by the European Commission, to represent healthcare professionals;
6. one member and one alternate member appointed by the European Commission, to represent patient organisations.
How often does the PRAC meet?
The PRAC meets on four consecutive days every month, and the dates for three years is decided in advance.
https://youtu.be/JhL03nyGgiA
Before the Good Pharmacovigilance Practices came into effect in July 2012, we had the Pharmacovigilance Working Party, or PhVWP.
The PhVWP held its last meeting in July 2012, when the new Pharmacovigilance Risk Assessment Committee, or PRAC came into operation.
Responsibility of PRAC
The PRAC is responsible for assessing all aspects of risk management of human medicines, including;
-
the detection, assessment, minimisation and communication of the risk of adverse reactions, while taking the therapeutic effect of the medicine into account,
-
design and evaluation of post-authorisation safety studies; and,
-
pharmacovigilance audit.
The PRAC provides recommendations on questions on pharmacovigilance and risk management systems, including the monitoring of their effectiveness, to the:
-
CHMP - Committee for Medicinal Products for Human Use for centrally authorised medicines and referral procedures;
-
CMDh - Coordination Group for Mutual Recognition and Decentralised Procedures for the Human products or the CMDh, on the use of a medicine in the Member States
-
The EMA secretariat, Management Board and European Commission, as applicable
What is the Composition of PRAC?
The PRAC consists of:
1. A Chair;
2. one member and one alternate member appointed by each of the EU Member States;
3. one member and one alternate member appointed by each of the EEA-EFTA States;
4. six members appointed by the European Commission,
5. one member and one alternate member appointed by the European Commission, to represent healthcare professionals;
6. one member and one alternate member appointed by the European Commission, to represent patient organisations.
How often does the PRAC meet?
The PRAC meets on four consecutive days every month, and the dates for three years is decided in advance.
Quote from VigiServe Admin on February 24, 2021, 1:59 PMRole of the PRAC in Pharmacovigilance Inspections
- The PRAC may make recommendations on the need and scope of "for cause" pharmacovigilance Inspections related to medicinal products of community interest.
- The PRAC may, in relation to issues of community interest and where considered appropriate, review the outcome of pharmacovigilance inspections and assess marketing authorisation holder-related corrective and preventative action plan submission(s) in order to make or endorse further recommendations on actions to be taken and their follow-up.
- The PRAC is also responsible for providing input in the preparation of and agreeing on the risk-based programme for routine pharmacovigilance inspections of marketing authorisation holders with centrally authorised products
Role of the PRAC in Pharmacovigilance Inspections
- The PRAC may make recommendations on the need and scope of "for cause" pharmacovigilance Inspections related to medicinal products of community interest.
- The PRAC may, in relation to issues of community interest and where considered appropriate, review the outcome of pharmacovigilance inspections and assess marketing authorisation holder-related corrective and preventative action plan submission(s) in order to make or endorse further recommendations on actions to be taken and their follow-up.
- The PRAC is also responsible for providing input in the preparation of and agreeing on the risk-based programme for routine pharmacovigilance inspections of marketing authorisation holders with centrally authorised products
Before the Good Pharmacovigilance Practices came into effect in July 2012, we had the Pharmacovigilance Working Party, or PhVWP.
The PhVWP held its last meeting in July 2012, when the new Pharmacovigilance Risk Assessment Committee, or PRAC came into operation.