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PV Hot Topics


Draft ICH E6(R3) Principles

ICH has published a draft version of the updated GCP principles that are currently under development by the E6(R3) Expert Working Group. A global web conference is also planned to present the current status.

New MedDRA Mappings

ICH has announced the release of new maps between SNOMED CT and MedDRA, which are intended to facilitate the exchange of data between regulatory databases and Electronic Health Records.

ABPI updates Guidance

The Association of the British Pharmaceutical Industry (ABPI) has published a revised version of its guidance on the management of safety information and product complaints from digital activities.

FDA Regulatory Action

The FDA has announced it is taking action against companies after failures concerning REMS requirements and ClinicalTrials.gov submissions.

COVID-19 Vaccines & Safety

In line with their defined strategies, the EMA, the MHRA and the ANSM continue to provide updates about the safety of approved COVID-19 Vaccines. Like for the AstraZeneca vaccine, the EMA concluded that the Janssen COVID-19 vaccine is associated to very rare cases of thromboembolic events.

Hot topics are taken from Safety Observer Lite May 2021