In the above video Esteban Herrero-Martinez, Regulatory Manager at the ABPI talks about the work of the ABPI Pharmacovigilance Expert Network in addressing the management of safety data from both company sponsored and non-company sponsored websites.
Email address for further comments: firstname.lastname@example.org
Download the ABPI white paper calling for a new approach to the management of safety data from non-company sponsored websites.
Read the article on the Inpharm Digital Pharma blog.
Download the guidance notes on the management of adverse events and product complaints from pharmaceutical company sponsored websites from the ABPI library.
Improving the management of internet derived medicine safety data: an update on ABPI activities
Dr Esteban Herrero-Martinez, ABPI Regulatory Manager
My name is Esteban Herrero, and I’m the ABPI regulatory Manager. Advances in information technology have resulted in a dramatic rise in both the amount, and type, of information around the safety of medicines that’s hosted on the Internet by both patients and healthcare professionals.
There’s no doubt that this data can be of great benefit to patients, but we need an appropriate regulatory framework that facilitates the use of this data to improve public health without increasing red tape.
There are two key issues the ABPI would like to address:
Firstly, we believe the management of safety information from non-company sponsored websites should be improved. We’ve published an article on the InPharm blog and a White Paper on the ABPI website that call for an improved approach, that focuses on the appropriate analysis of this data to improve medicines safety and away from rigid regulatory reporting requirements.
Secondly, we have published best practice guidance for the management of safety information in company sponsored websites, to help companies meet their regulatory obligations in this situation.
In short, we hope the work the ABPI has been doing in this area will lead to a better approach to the analysis of this data to manage medicines safety, which ultimately will lead to improved protection for patients.
Timing is crucial however, we have new pharmacovigilance, or drug safety, legislation that was approved in Europe in December 2010, and the implementing guidance for this legislation is currently being drafted. We have an opportunity now to influence the drafting of this implementing guidance to improve the current situation.
If you have any comments or any questions about the work of the ABPI in this area please follow the links at the end of this video.