Wednesday 21st April 9.30am - 1.15pm followed by buffet lunch

The Commonwealth Club, 25 Northumberland Avenue, London WC2N 5AP

This special meeting is being held to brief members on the full implications of the recent revisions to the ABPI's Adverse Event Reporting Guidelines and the implementation plan for market research.

The BHBIA Ethics Team is in the final stages of consultation with the ABPI Pharmacovigilance Expert Network, to define workable processes for reporting that meet the MHRA's criteria whilst minimising the impact on market research objectives and processes. This consultation has involved reviewing specific examples of different market research methodologies, sample sizes and scenarios so that specific guidance can be given to members on exactly what is reportable and how events need to be forwarded.

From 1st May it will be expected that all MR projects will have AE processes in place that are compliant with the ABPI's revised guidelines. We therefore urge all BHBIA members to ensure that your organisation is represented at the meeting on 21st April, at which we will share advice on interpretation of the new guidance and best practice for complying with it.

This will be a joint meeting with the ABPI and Pharmacovigilance Expert Network, members of which will be on hand to provide advice, as part of an Expert Discussion Panel.

Please note that this meeting is open to full BHBIA member companies only (Pharma companies, Agencies & Consultancies, Affiliate member companies and Personal members). We encourage pharma companies to invite your pharmacovigilance teams to the meeting - they should also book using the link below.

There will be a nominal fee of £75 VAT per person, to cover refreshments and venue costs.

Click here to view the full programme for the day.

Click here to book your places online now.

Please be assured that all BHBIA members will have access to a full briefing on the guidance, whether or not you are able to attend on 21st April. We will be updating the web-based AER Training Programme and Competency Test before the end of April, and all members will be expected to take the training and obtain a new Certificate of Competency.

You may also be interested in our one-day Guidelines Workshop on 27th May. This training workshop covers all aspects of the BHBIA Guidelines (Legal and Ethical Framework) but also provides a further opportunity for discussion of issues specific to the AER changes. Click here for more information.