Clinical Trial Safety & & Pharmacovigilance

CLINICAL TRIAL SAFETY  & PHARMACOVIGILANCE - Conference

UPDATE on legislation and latest industry experience 

8 & 9 JUNE 2011 -  Copenhagen

Key topics

• New EU Pharmacovigilance Legislation: Which are the major changes & implications?
• EudraVigilance Expert Working Group – new IME list
• Data Privacy versus Drug Safety – what to do?
• From Annual Safety Report to DSUR (Development Safety Update Report)
• Recent US legislation & regulation on pharmacoviligance
• Trends from inspections – MHRA & industry experiences
• Signal detection – recent development and trends
• New Individual Case Safety Report (ICSR)
• Cross-organisational Safety Risk Management (SRM)
• Insourcing and outsourcing of pharmacovigilance activities – advantages and pitfalls
• Discussion: Pharmacovigilance setup in BRIC countries 

Key speakers

• Dr. PhD Pharmacovigilance Inspector Dominic Nguyen-Van-Tam MHRA (UK)
• William RM Long, Sidley Austin LLP (UK)
• Head of Pharmacovigilance Department Hervé le Louet, Henri Mondor Hospital / APHP (F)
• Chief Medical Officer Doris Stenver, Danish Medical Agency (DK)
• Dr. jur. & Dr. med. Adem Koyuncu, Mayer Brown LLP (DE)
• Internal Consultant Compliance Ian Oulsnam, QA GCP, GP vP & GLP Compliance,
Leo Pharma A/S (UK/DK)
• Member of the Firm Benjamin S. Martin EbsteinBeckerGreen (US)