2012 was a significant year for the drug safety sector as the European Pharmacovigilance Legislation impacted on the regulatory expectations, strategy planning and operational execution for European and International organisations. Outside of Europe, companies continued to refine and develop their drug safety best practice and to try to find solutions to some of the key challenges that face us all.
The World Drug Safety Congress Americas 2013 has an outstanding agenda and speaker panel that will unite on 24-25 April at the Revere Hotel Boston Common, and provide fresh and innovative solutions to some of the industry’s issues and open debate and discussion to really add value to your attendance.
As a preview to the event itself we asked some industry experts to provide their thoughts on making the right decisions regarding drug safety strategy and the changing regulatory environment.
Firstly we asked Rudi Scheerlinck, Head Global Drug Safety, Basilea, What do you see as the biggest benefit to patient safety stemming from the new EU legislation. When will we start to see this? ‘The changes to the EU legislation cover a broad spectrum of activities related to pharmacovigilance. The biggest benefit might be the increased transparency. This was one of the main objectives of the new regulation and was systematically addressed in the GPV modules that were released; examples are numerous, ranging from the publication on the EMA website of the PRAC minutes to summaries of an RMP in a language understandable for the lay public.
This increased transparency allows patients to see what is going on. Moreover, companies see what is going on at competitors and can pro-actively look into their data. This phenomenon has already started. Overall, the increased transparency might lead to a fair treatment of similar issues across products and companies. The EMA website makes the public more familiar with matters such as risks and safety signals. If coupled to an adequate educational program, this might help the public and the media to better perceive the risks and this might lead to a development of a risk acceptance. At the end, this may increase the credibility of the pharmaceutical industry too. These might be outcomes that are more difficult to measure and that might take more time.’
Secondly we asked Peter De Veene, EU Qualified Person Pharmacovigilance, Roche, What has been the biggest challenge in implementing the changes in the wider global market? ‘Different territories have not adapted their regulations to the EU ones, so one of the biggest challenges is to harmonise processes at a company level.’
Thirdly we asked Paul Beninger, Vice President Global Patient Safety and Risk Management, Genzyme, What has been the biggest change in the US market for drug safety and pharmacovigilance over the past 12 months? ‘Counterfeit products. Criminal elements have moved from drugs of abuse to oncology products, such as seen last year with Avastin. We must learn the lessons of the heparin tragedy and now counterfeit oncology products in order to move in a timely way to develop secure and pedigreed products that the health care industry and patients can trust.’
Rudi, Peter and Paul will be speaking at the World Drug Safety Congress Amercias 2013.
The 5th annual World Drug Safety Congress provides you with key insights into the drug safety challenges affecting you and gives you an excellent opportunity to discuss these diverse issues in a conference format.
For further information please click here.
Source: World Drug Safety Congress