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PV Hot Topics

Blog - MHRA Inspectorate
MHRA GPvP Inspectorate Guide to Marketing Authorisation Holder Considerations for Agreements with Pharmacovigilance System Service Providers
The pharmacovigilance systems of marketing authorisation holders are often dependent on multiple third parties; extensive outsourcing and partnering is a feature of the pharmaceutical industry as much as any other. This blog expands upon the areas identified as problematic for MAHs and service providers and provides points to consider when producing contracts and agreements text.

EMA issues new draft GVP guidance
The EMA has released for comments the draft of a new Product or Population-specific considerations guidelines, which covers the population of pregnant and breastfeeding women.

EMA & Signal Detection
The EMA has announced that the Signal Detection Pilot, which started on 22-Feb-2018, has now been extended until the end of 2021 following the review of the experience gained in the first year of the pilot.

New EMA report on PV legislation
The EMA has issued a new report on the implementation of the Pharmacovigilance legislation, which describes the key achievements over the period 2015 – 2018 and their impact on public health.

New GVP Guideline in Algeria
The CNPM has published a new Guide that describes the Pharmacovigilance System in the country and the role of the stakeholders. The guide covers various topics and brings new changes to the safety reporting requirements.

Hot topics are taken from Safety Observer Lite 163, Jan 2020