European Regulatory Affairs Forum

Venue: Le Meridien Hotel Munich

Location: Munich, Germany

Event Date/Time: Nov 24, 2008 End Date/Time: Nov 25, 2008
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Description

• Scientific Advice and the Transatlantic Simplification Process
• Centralised procedure: New market authorisation procedures and
case studies
• Update on Variation Regulations
• Update on CMD(h) - Activities and the network
• MRP / DCP procedures
• Choice of RMS and availability of NCA resources
• CMD(h) and CHMP referrals - interaction and case studies
• Harmonisation of SmPCs of national MA's
• The proposed new Pharmacovigilance Legislation
• PSUR work-sharing and the link between PSURs and risk
management plans
• Transparency and public disclosure
- Risk communication guideline
- EudraCT and the impact of Paediatric Regulation
• Risk management plans and Post Authorisation Safety Studies (PASS)
• Risk management case studies
• Telematics Roadmap and impact on regulatory business
• Centralised procedure: eSubmission practicalities, Product
Information Management (PIM) and case studies
• NCA implementation of electronic initiatives: eCTD and NeeS.

Venue

Bayerstrasse 41
Munich
Germany
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