Our live webinar "Understanding the New EU PV Regulations," aired late September to the highest number of registrants we have ever had for a webinar. I would like to thank our well-informed and excellent presenters Sue Rees, BSc (Hons) MSc, Hon FPIPA, Head of Pharmacovigilance and Safety Risk Management & EU QPPV at Eisai Europe Ltd, and Peter De Veene, MD, a EU Qualified Person for Pharmacovigilance (EU QPPV) at Roche Products Ltd. The webinar was hosted by Applied Clinical Trials, in conjunction with Pharmaceutical Executive and our joint website http://www.drugsafetydirections.com/, which was launched with sponsorship from Oracle Health Sciences. When the EU announced changes to its pharmacovigilance legislation at the end of December 2010, it was lauded as the most far-reaching change to legislation since the formation of the EMA itself. But since the announcement, there has been little guidance on implementation from the regulatory authorities until mid-September, when a consultation document was released, drafted on the basis of technical work by a team of experts from member states and the EMA. That means, say commission officials, that it does not necessarily represent the position of the European Commission. "Instead, it is a tool to explore the views of interested parties on a preliminary proposal." The views on the rather large proposal are due into the commission by November 7.
Applied Clinical Trials, Nov 1, 2011