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Pharmacovigilance (PRAC-pharmacovigilance Risk Assessment Committee…
Pharmacovigilance
PRAC-pharmacovigilance Risk Assessment Committee
Reports to the CHMP,CMDh,EMA and EC
Evaluates safety signals from Eudravigilance
Members from member states
Reduces no of ADRs by: better collection of data,rapid assessment of issues,effective regulatory action.
electronic exchange of ICSR
History of Regulation
1906 Food and Drug Act,Elixir Sulfinilamide 1930s,1938 Federal Food and Drug and Cosmetics Act,1950's France ,Thalidomide 1957-1961,phocomelia,1961 WHO Monitoring Centre,1962 Kefauver-Harris Act.
200,000 deaths in EU per year from medication side effects
5% of hospital admissions
5th most common cause of hospital deaths
comprehnsive review 2005
Eudravigilance
Medicines and clinical trials
QPPV
Qualified Person in the EEA for PV
PSMF
Pharmaceutical System Master File
MeDRA
Medical Dictionary for Regulatory Activities
XEVMPD-extendedEudravigilance Medicinal Product Dictionary
PASS-post authorisation safety studies
PSUR and ICSR
Clinical Trials vs. post marketing surveillance,the differences
MAH,CA and EMA
Research and development-Eudrvigilance
Post authorisation surveillance
MA-Risk Management
GVP
New regulation 2012-post Mediator drug scandal in France
Clinical trials vs. post authorisation use
2001/83/EC,2010/84/EC and reviewed post mediator 2012/26/EU
Balance of benefit:risk
New role of patient