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Webinar

ABPI & BHBIA AE/PC/SRS Guidelines – Medical Devices Update

via Zoom
Thursday 18 March 2021, 12.30 - 1.30pm

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Please note change of date (was previously advertised for Friday 19th March).

The ABPI and BHBIA have updated their joint Guidance notes on collecting adverse events, product complaints and special reporting situations during market research and adverse event reporting for medical devices is now required. 

This means that the same requirements for AE/PC/SRS reporting for medicinal products will be extended to medical devices. 

The update has been prompted by the recently passed UK Medicines and Medical Devices Act 2021 which requires more stringent safety reporting. The UK law will be followed in the EU by the Medical Devices Regulation which comes in to force on 26 May 2021. 

Whilst we strongly recommend that all members put the guidance in to effect as soon as practical, the BHBIA (which requires its members to adhere to the guidance requirements) will allow until 26 May 2021 for members to have fully compliant policies and processes in place. However please note the UK Medicines and Medical Devices Act 2021 is now in force. 

This joint BHBIA/ABPI webinar will explain and illustrate the impact of the updated guidance. 

It will include time for Q&A with the ABPI and BHBIA presenters. 

The webinar is suitable for anyone engaged in recording or monitoring AE/PC/SRSs from market research work whether on the company or agency side but it is particularly important that those in device manufacturers keep up to date with the new requirements. 

Speakers: 

  • Catherine Ayland - BHBIA Ethics Advisor 
  • Camille Bach - Novartis Patient Safety Senior Specialist, Novartis Pharmaceuticals UK Limited 
  • Yuliya Fontanetti - Deputy Chair, BHBIA Ethics & Compliance Committee / Global Director of Project Management and Compliance, Cello Health Insight 
  • Belen Granell Villen - Quality and Safety Policy Executive, The Association of the British Pharmaceutical Industry 
Online booking:

Click on the register for event button below. Please note you must be logged in as a member to book online. 

If you belong to a BHBIA member company but don't yet have a log in please register now to join your company's membership.

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