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Title Event Type Day Time Track(s) Credits
Student Tutorial - An Overview of the Regulatory Framework in the European Union Tutorial Sunday, Mar 25 2:00PM - 5:30PM
Roundtable 01: GCP Inspections and Audit Findings Tutorial Monday, Mar 26 9:00AM - 12:30PM
Tutorial 02: The new adverse reaction reporting rules, ICH E2B (R3) implementation guide and changes in EudraVigilance in the context of the context of the new European Pharmacovigilance Legislation. Tutorial Monday, Mar 26 9:00AM - 12:30PM
Tutorial 02: The new adverse reaction reporting rules, ICH E2B (R3) implementation guide and changes in EudraVigilance in the context of the context of the new European Pharmacovigilance Legislation. Tutorial Monday, Mar 26 9:00AM - 12:30PM
Tutorial 03: Analysis of Safety Data from Clinical Trials Tutorial Monday, Mar 26 9:00AM - 12:30PM
Tutorial 03: Analysis of Safety Data from Clinical Trials Tutorial Monday, Mar 26 9:00AM - 12:30PM
Tutorial 04: The New Variation Regulation in Practice - Advantages and Pitfalls Tutorial Monday, Mar 26 9:00AM - 12:30PM
Tutorial 05: Introduction to Medical Device Regulation Tutorial Monday, Mar 26 9:00AM - 12:30PM
Tutorial 05: Introduction to Medical Device Regulation Tutorial Monday, Mar 26 9:00AM - 12:30PM
Tutorial 06:Basic Concepts in Equivalence/Noninferiority Testing: Issues and Challenges Tutorial Monday, Mar 26 9:00AM - 12:30PM
Tutorial 07: Recent and Current developments in Pharmaceutical Law and Regulatory affairs in the EU Tutorial Monday, Mar 26 9:00AM - 12:30PM Theme 15 - Stand Alone
Tutorial 07: Recent and Current developments in Pharmaceutical Law and Regulatory affairs in the EU Tutorial Monday, Mar 26 9:00AM - 12:30PM Theme 15 - Stand Alone
Tutorial 08: How to Apply Non-clinical Safety Guidelines in First-in-Humans Trials and for Marketing Application? Tutorial Monday, Mar 26 9:00AM - 12:30PM Theme 15 - Stand Alone
Tutorial 08: How to Apply Non-clinical Safety Guidelines in First-in-Humans Trials and for Marketing Application? Tutorial Monday, Mar 26 9:00AM - 12:30PM Theme 15 - Stand Alone
Tutorial 09: Safety Data Analysis and Query Creation with MedDRA Tutorial Monday, Mar 26 9:00AM - 12:30PM
Tutorial 09: Safety Data Analysis and Query Creation with MedDRA Tutorial Monday, Mar 26 9:00AM - 12:30PM
Tutorial 11: After the PIP Decision: Modification of the agreed PIP, Validation and Compliance Check Tutorial Monday, Mar 26 9:00AM - 12:30PM Theme 15 - Stand Alone
Tutorial 12: Orphan Drugs in the EU: From designation to Marketing Authorisation Tutorial Monday, Mar 26 9:00AM - 12:30PM Theme 15 - Stand Alone
Tutorial 13: Incentives To Drug Development: Expand Your Regulatory Intuition Tutorial Monday, Mar 26 9:00AM - 12:30PM
Tutorial 14: Introduction to Crisis Management Tutorial Monday, Mar 26 9:00AM - 12:30PM
Tutorial 14: Introduction to Crisis Management Tutorial Monday, Mar 26 9:00AM - 12:30PM
Tutorial 15: Tools and Techniques for Optimal Portfolio Planning in Global Drug Development Tutorial Monday, Mar 26 9:00AM - 12:30PM
Tutorial 16: Development of Paediatric Medicinal Products from a Regulatory Point of View Tutorial Monday, Mar 26 9:00AM - 12:30PM Theme 15 - Stand Alone
Tutorial 16: Development of Paediatric Medicinal Products from a Regulatory Point of View Tutorial Monday, Mar 26 9:00AM - 12:30PM Theme 15 - Stand Alone
Tutorial 17: Health Technology Assessment (HTA): A User’s Guide Tutorial Monday, Mar 26 9:00AM - 12:30PM
Tutorial 18: Statistics without Mathematics Tutorial Monday, Mar 26 9:00AM - 12:30PM
Tutorial 18: Statistics without Mathematics Tutorial Monday, Mar 26 9:00AM - 12:30PM
Tutorial 19: Data Privacy in Clinical Trials and Pharmacovigilance Tutorial Monday, Mar 26 9:00AM - 12:30PM
Tutorial 20: Basic Considerations To Create A Proper CMC File Tutorial Monday, Mar 26 9:00AM - 12:30PM
Tutorial 21: Scientific, Ethical and Regulatory Challenges of Local Cinical Trials Required for Registration in Emerging Markets Tutorial Monday, Mar 26 9:00AM - 12:30PM
Tutorial 21: Scientific, Ethical and Regulatory Challenges of Local Cinical Trials Required for Registration in Emerging Markets Tutorial Monday, Mar 26 9:00AM - 12:30PM
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