How EFPIA Set The Bar On Drug Safety Reporting During COVID-19
Early disruptions caused by the coronavirus pandemic prompted the European pharmaceutical industry body, EFPIA, to establish a principles-based framework to help ensure consistency in managing compliance with pharmacovigilance responsibilities.
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Drug companies unable to continue with standard reporting of suspected adverse reactions to the EU pharmacovigilance database can temporarily prioritize their reporting activities to focus on COVID-19 related safety events.
Scrip contacted a cross section of pharma firms in India to get a sense of how they are handling the extraordinary work-operations-employee well-being situation amid the coronavirus outbreak. Work from home mandates, deploying digital tools wherever possible, cut-back in field activities and daily temperature checks at sites are some of the initiatives set in motion.
The European Medicines Agency is developing a strategy to ensure that women have sufficient information to make informed choices about taking medicines during pregnancy and breastfeeding.