Tuesday, February 12, 2013

Pre-conference Tutorials - Monday, 4 March 2013 Amsterdam

pdf View in Programme [PDF]

Available with new instructors!
Tutorial 1 - Highlights of the Implementation of the New Pharmacovigilance Legislation with Regard to Adverse Reaction Reporting Rules, Use of New International Standards and Signal Management in Eudravigilance

Tutorial 2 - Analysis of Safety Data from Clinical Trials

Tutorial 3 - Update on Practical Work with Variations Under the Revised Regulation

Tutorial 4 - Introduction to EU Mecical Device Regulation

Tutorial 5 - Recent and Current Developments in Pharmaceutical Law

Tutorial 6 - CANCELLED - Incentives for Drug Development
NEW!Tutorial 7 - The Dialogue and Negotiation Process Between Applying Company and the Paediatric Committee of the European Medicines Agency

Tutorial 8 - Health Technology Assessment (HTA) of Drugs and Medical Devices

Tutorial 9 - The European Qualified Person for Pharmacovigilance; Everything you ever wanted to know but were afraid to ask

Tutorial 10 - Non-Clinical Safety Assessment in Global Pharmaceutical Development

Tutorial 11 - Interactions Between Regulatory and Intellectual Property, Privacy and Product Liability

Tutorial 12 - Development Safety Update Report (DSUR) Kick-Off in 2011 - And now in practice

Tutorial 13 - Technology Transfer for Biopharmaceuticals

Tutorial 14 - Pharmacovigilance Audits and Inspections

Tutorial 15 - Coding with Confidence

Tutorial 16 - Understanding Translational Medicine

Tutorial 17 - Creating Compliant Clinical Study Reports (CSRS) for the EU and US

Tutorial 18 - Roundtable Discussion (Special Fee €200 + VAT): GCP Inspection and Audit Findings

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