Theme 03 - Legal/Transparency-Risk Assessment (22)
- Title: REGULATORY DATA PROTECTIONDay: Tuesday, Mar, 05
Event Type: SESSION
Tracks: Theme 03 - Legal/Transparency-Risk Assessment
Time: 9:00AM - 10:30AM - Title: INCENTIVES FOR PAEDIATRIC CLINICAL RESEARCHDay: Tuesday, Mar, 05
Event Type: SESSION
Tracks: Theme 03 - Legal/Transparency-Risk Assessment
Time: 11:00AM - 12:30PM - Title: LEGAL COMPLIANCE FOR REGULATORY FUNCTIONS - LEARNINGS FROM RECENT ENFORCEMENT ACTIVITIESDay: Tuesday, Mar, 05
Event Type: SESSION
Tracks: Theme 03 - Legal/Transparency-Risk Assessment
Time: 2:00PM - 3:30PM - Title: TRANSPARENCY ON DOSSIER AND DECISION MAKING – HAS PUBLIC TRUST INCREASED?Day: Wednesday, Mar, 06
Event Type: SESSION
Tracks: Theme 03 - Legal/Transparency-Risk Assessment
Time: 11:00AM - 12:30PM - Title: LEGAL AND PRACTICAL ASPECTS OF OFF-LABEL USEDay: Wednesday, Mar, 06
Event Type: SESSION
Tracks: Theme 03 - Legal/Transparency-Risk Assessment
Time: 2:00PM - 3:30PM - Title: Tutorial 02: Analysis of Safety Data from Clinical TrialsDay: Monday, Mar, 04
Event Type: TUTORIAL
Tracks: Theme 03 - Legal/Transparency-Risk Assessment
Time: 9:00AM - 12:30PM - Title: Tutorial 03: Update on Practical Work with Variation RegulationDay: Monday, Mar, 04
Event Type: TUTORIAL
Tracks: Theme 03 - Legal/Transparency-Risk Assessment
Time: 9:00AM - 12:30PM - Title: Tutorial 04: Introduction to Medical Device RegulationDay: Monday, Mar, 04
Event Type: TUTORIAL
Tracks: Theme 03 - Legal/Transparency-Risk Assessment
Time: 9:00AM - 12:30PM - Title: Tutorial 05: Recent and Current developments in Pharmaceutical LawDay: Monday, Mar, 04
Event Type: TUTORIAL
Tracks: Theme 03 - Legal/Transparency-Risk Assessment
Time: 9:00AM - 12:30PM - Title: Tutorial 7: THE DIALOGUE AND NEGOTIATION PROCESS BETWEEN APPLYING COMPANY AND THE PAEDIATRIC COMMITTEE OF THE EUROPEAN MEDICINES AGENCYDay: Monday, Mar, 04
Event Type: TUTORIAL
Tracks: Theme 03 - Legal/Transparency-Risk Assessment
Time: 9:00AM - 12:30PM - Title: Tutorial 08: Health Technology Assessment of Drugs and Medical DevicesDay: Monday, Mar, 04
Event Type: TUTORIAL
Tracks: Theme 03 - Legal/Transparency-Risk Assessment
Time: 9:00AM - 12:30PM - Title: Tutorial 09: The European QP for Pharmacovigilance: Everything you ever Wanted to know but were afraid to askDay: Monday, Mar, 04
Event Type: TUTORIAL
Tracks: Theme 03 - Legal/Transparency-Risk Assessment
Time: 9:00AM - 12:30PM - Title: Tutorial 10: Non-Clinical Safety Assessment in Global Pharmaceutical DevelopmentDay: Monday, Mar, 04
Event Type: TUTORIAL
Tracks: Theme 03 - Legal/Transparency-Risk Assessment
Time: 9:00AM - 12:30PM - Title: Tutorial 11: Interactions between Regulatory and Intellectual Property, Privacy and Product LiabilityDay: Monday, Mar, 04
Event Type: TUTORIAL
Tracks: Theme 03 - Legal/Transparency-Risk Assessment
Time: 9:00AM - 12:30PM - Title: Tutorial 12: Development Safety Update Report (DSUR) Kick-off in 2011: Then and KnowDay: Monday, Mar, 04
Event Type: TUTORIAL
Tracks: Theme 03 - Legal/Transparency-Risk Assessment
Time: 9:00AM - 12:30PM - Title: Tutorial 13: Technology Transfer for Biopharmaceuticals WorkshopDay: Monday, Mar, 04
Event Type: TUTORIAL
Tracks: Theme 03 - Legal/Transparency-Risk Assessment
Time: 9:00AM - 12:30PM - Title: Tutorial 14: Pharmacovigilance Audits and InspectionsDay: Monday, Mar, 04
Event Type: TUTORIAL
Tracks: Theme 03 - Legal/Transparency-Risk Assessment
Time: 9:00AM - 12:30PM - Title: Tutorial 15: Coding with ConfidenceDay: Monday, Mar, 04
Event Type: TUTORIAL
Tracks: Theme 03 - Legal/Transparency-Risk Assessment
Time: 9:00AM - 12:30PM - Title: Tutorial 16: Understanding Translational Medicine: Benefits and Innovative ApproachesDay: Monday, Mar, 04
Event Type: TUTORIAL
Tracks: Theme 03 - Legal/Transparency-Risk Assessment
Time: 9:00AM - 12:30PM - Title: Tutorial 17: Creating Compliant Clinical Study Reports for the EU and USDay: Monday, Mar, 04
Event Type: TUTORIAL
Tracks: Theme 03 - Legal/Transparency-Risk Assessment
Time: 9:00AM - 12:30PM
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