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

via Zoom
Thursday 18 March 2021, 12.30 - 1.30pm

Webinar recording and slides are now available. These are available to full BHBIA members only - you will need to log in to access them - once logged in, the details will appear on the page below this text. 

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.

In this webinar, speakers from the BHBIA and ABPI will explain and illustrate the impact of the updated guidance and what this means for you. 


Catherine Ayland is an independent market research consultant specialising in the healthcare field.  Catherine has been the BHBIA’s independent Ethics Consultant since 2005 and in this capacity she is responsible for developing and maintaining the BHBIA’s Legal and Ethical Guidelines.  

Prior to working as a freelance consultant, which she has done for the last 23 years, Catherine spent 13 years on the client side, ultimately heading up the international market research team within Boots Pharmaceuticals. 

Catherine's role involves regular liaison with the MRS, the ABPI (Association of the British Pharmaceutical Industry), the PMCPA (the Prescription Medicines Code of Practice Authority), the ICO (information Commissioners Office) and with EphMRA (European Pharmaceutical Market Research Association) and ESOMAR too.

I am a Doctor of Pharmacy with experience in Quality Assurance and Pharmacovigilance. Currently working as a Patient Safety Senior Specialist for Novartis.

Helped on the update of the AE guidance by adding reference and updates linked to the new EU Regulation on Medical Devices and addition of practical examples.

Having worked in the healthcare market research arena for most of her career, Yuliya’s passion for uncovering research insights has been supported by gaining robust experience across numerous therapy areas and methodological approaches over the years.

Through her avid interest in high quality data and a real fascination with healthcare research, Yuliya has developed extensive data collection expertise and the desire to deliver ‘gold standard’ within MR by combining the drive for innovative approaches with guideline adherence and understanding.

A naturally keen ambassador for ethical compliance and guidelines, Yuliya joined the BHBIA Ethics & Compliance Committee in early 2018 to help drive compliance across the industry and has since spoken at several successful BHBIA events.

Belen originally qualified as a pharmacist in Spain and has 6 years of working experience as a hospital pharmacist. When she moved to London, she worked first as clinical editor in the BNF. And when the opportunity came up in 2016, she started working in life science policy at ABPI. 

Her current areas of expertise are quality and mainly the safe use of medicines. Her contribution to this guideline was to project manage a group of ABPI expert PV members, as well as contributing to update the content itself.

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