Pharmacovigilance : Post Marketing Authorisation Flashcards
1
Q
What is collected throughout drug development in clinical trials?
A
Safety Data
2
Q
Which legal texts come under pharmacovigilance?
A
EU Regulation No 1027 / 2012
Directive 2012 / 26 / EU
3
Q
What is the central aim of legal texts under pharmacovigilance?
A
Reduce the number of ADRs.
4
Q
What is the Good Pharmacovigilance Practice (GPvP)?
A
Minimum standard for monitoring the safety of medicine on sale to the public in the EU.
5
Q
What does the MHRA inspect using the ‘Good Pharmacovigilance Practice’?
A
Inspects market authorisation holders.
6
Q
What is the role of the EMA (European Medicines Agency)?
A
Responsible for implementing and operating much of the pharmacovigilance legislation.
7
Q
What are the partnerships with EMA?
A
European Commission Pharmaceutical Companies National Competent Authorities (MHRA) Patients Healthcare Professionals
