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AE in Motion - Update on key changes to Adverse Event Guidelines

Friday 21 September 2018, 12:30 PM - 1:30 PM

The new ABPI/BHBIA Guidance notes on collecting adverse events, product complaints and special reporting situations during market research were published on 14th August.

The key change is that when AEs are collected directly from patients or consumers, market researchers now need if possible to collect the patient/consumer’s contact details and forward these details to the MAH pharmacovigilance (PV) team so that they can follow up where needed. This change was necessary to allow our PV colleagues to meet their EMA (European Medicines Agency) obligations.

In this webinar we will provide:

  • An overview the new requirements, including background to the changes
  • Practical advice on implementation
  • Q&A with members of the Ethics & Compliance Committee and our guest speaker, Melanie Adams of the ABPI

To help us maximise efficiency on the day, it would be very helpful if you could submit your questions in advance via SmartSurvey - preferably by 14th September.

See speaker details

Full members can now view the recording of this webinar (you will need to log in to access it).