DIA European Regulatory Affairs Forum 2010

Venue: Hilton London Canary Wharf Hotel

Location: London, United Kingdom

Event Date/Time: Jun 01, 2010 End Date/Time: Jun 02, 2010
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This interactive meeting offers an exceptional opportunity for professionals working in
industry, national competent authorities, health ministries, academia, CROs as well as
for consultants and interested patient organisation delegates to interact with key
speakers from regulatory agencies and industry. The meeting is of particular interest for
professionals working in regulatory affairs, clinical research and project management,
as well as people involved in labelling, scientific advice and pharmacovigilance. Real-life
examples and interesting case studies will be presented, operational topics will be
explored and you will hear about:
• New Variation Regulation – Six Months Experience
• SmPC and Labelling
• A New Era in Pharmacovigilance
• Centralised Procedure / CHMP / European Medicines Agency
• Optimal Use of EU Scientific Advice Procedures – Case Stories and Orphan Drug
Case Stories
• Clinical Trials Directive - Heads of Medicines Agencies
• Globalisation of Regulatory Affairs, Rules and Authorities