Drug Information Association, Le Meridien Hotel Munich
Nov 24 2008
• 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.
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