Leading European Regulatory Network Representatives debate challenges
Today the foremost experts from the European Medicines Agency, National Agencies, Industry Representatives and the European Commission opened the 4th TOPRA Annual Symposium by focusing on the major challenges between now and 2010 and beyond.
A heightened demand for resources was a topic mentioned by several speakers, given the evolving nature of the European Regulatory Network and new responsibilities stemming from regulations such as paediatrics and risk management. Symposium co-host, Jytte Lyngvig, Chief Executive Officer of Danish Medicines Agency and Chairman of the Heads of Medicines Agencies Management Group said, ‘It’s not about working harder, we’ve got to work smarter…we have to make the European vision work. That’s not only the vision of the Commission or the vision of the Heads of Medicines Agency, it’s our collegiate work.’
Martin Terberger, Head of Unit, DG Enterprise and Industry, Directorate unit (F2), gave the Commission’s perspective of the road ahead to 2010. He said that while 2007 has been a year of assessment and implementation, instead of any major new directives or initiatives. Terberger said that the Commission will bring forward three proposals for legal action in areas of pharmacovigilence, variations and patient information. The effort to streamline variation regulation is likely to be warmly welcomed by industry and regulatory affairs professionals. Modernisation of the regulations regarding patient information is likely to incorporate the contemporary ways that patients access information - including the internet.
Noel Wathion, representing the European Medicines Agency, discussed the priorities of the Agency over the next few years. He said that increasing demands by stakeholders was prompting reconsideration of
how to best fulfil objectives. Core areas of emphasis are implementing new legislation, monitoring existing legislation and preparing for possible future legislation. All of this must be undertaken as part of a process that now involves three committees - COMP, CHMP, and PDCO.
The subsequent discussion session amongst delegates and panellists covered a range of topics raised by speakers. One major point stressed by Terberger and Lyngvig is that officials, whether in national or European contexts, operate within a political environment where they are often charged to fulfil political imperatives. It’s simply impossible to get away from that - which may be in part why Terberger believes that 2009 will be a quieter year for the regulation with the establishment of a new Commission and a new Parliament. On another point, Terberger stressed that the key for better outcomes is for all stakeholders within the European Regulatory Network to work together in a spirit of mutual trust and openness.
The Symposium continues through Friday.
For more information, contact:
Jacob Coy // Cicero Consulting // 0207 665 9530
