Periodic Safety Update Reports (PSURs):-A. PSURs submitted after exit daya. MHRA will continue to accept EU version of PSURsb. MHRA specific request for information needs to be included in specific annexurec. MHRA has developed its own submission requirements and develop a list of...
Sep 30, 2019
Sep 22, 2019
Service Level Agreement (SLA) in Pharmacovigilance perspective
Drug Safety Guru
Drug Safety, Pharmacovigilance, Service Level Agreements, SLA
Service Level
Agreement (SLA) is generally mutual commitment between service provider and a client. In pharmacovigilance
industry, pharmacovigilance
service provider and pharmaceutical company (client) come together in agreement
for various PV activities. This could be single PV activity or End...
Sep 14, 2019
Article 31 -EMA to review ranitidine medicines following detection of NDMA
Drug Safety Guru
Article-31, EMA, NDMA, Ranitidine
Under Article 31 of Directive 2001/80/EC, the review of
ranitidine containing medicines was initiated at the request to the European
Commission. This review will be carried out by the Committee for Medicinal
Products for Human Use (CHMP). The CHMP opinion will then be forwarded...