What will big changes in Europe’s pharmacovigilance legislation landscape mean for the way pharma operates now and in the future?
This question is one that seems to be constantly queried within the pharma industry recently, as professionals debate what significant challenges their organisations will face and how these can be overcome. We recently asked Ralph Nies, Vice President Drug Safety & Pharmacovigilance, Astellas Pharma Europe R&D, how the new European pharmacovigilance legislation will shape his company’s safety activities and work structure in the next 6 months? Also what he sees as the main difficulties going forward?
“At our company, we have a policy that all information that might impact the safety profile of our product is forwarded to the PV Department. We currently have an ongoing global project for the implementation of the new EU Legislation, sponsored by the CEO of the company. The main challenge is to ensure cross-functional gathering of safety relevant information in the right format for the PV System Master File. Pharmacovigilance has to be lived by the entire corporation; PV Department is only a steward of Safety.”
Ralph Nies will be giving a presentation about legislative requirements for the pharmacovigilance system with focus on the Pharmacovigilance System Master File at the 6th annual World Drug Safety Congress Europe 11th – 13th September 2012 at The Grange City Hotel, London, UK. This conference will address the key challenges for drug safety professionals Worldwide and also the crucial issues in the development and execution of drug safety programmes, including topics:
- Emerging Market Focus
- International Regulatory Roundup
- Risk Management & Communication
- Benefit Risk Decision Making
- Signal Reporting & Management
- Clinical Safety Strategy
- Safety in Early Development
- Observational Studies/Post Approval Safety
The event comprises of a 2 day conference, a pre-conference seminar which discusses ‘safety challenges for biologics’, interactive panel Q&A sessions, and unique networking opportunities via our specialised ‘contact’ system.
Additional speakers include representatives from Merck Serono, GlaxoSmithKline Vaccines, Bayer Healthcare, Baxter and many more.
For further information please visit http://www.healthnetworkcommunications.com/safetyeur
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