Tutorial 01: INTRODUCTION TO EU PHARMACEUTICAL LAW AND CURRENT DEVELOPMENTS Day & Time:
March 25, 9:00AM - 12:30PM (Central European Standard Time)Room Number:
Pharmaceutical law is at the base of daily business in the sector. In the last few years many developments have occurred in the field of pharmaceutical law as well as in the marketing authorisation practice. This tutorial gives you a general introduction to the legal framework, and it brings you up to date in respect of recent and ongoing changes, e.g.: - Marketing Authorisation for Biosimilars - Paediatric Regulation - Advanced Therapy Medicinal Products Regulation - Pharmaceutical Package: Pharmacovigilance legislation; Directive on Falsified Medicines; proposed legislation on information to patients - New Guidelines and Notes for Guidance - Revision of Clinical Trials Legislation. For each of the topics the most relevant highlights will be presented in an interactive manner.Learning Objective(s):
• Understand the basics of the legal framework of pharmaceutical legislation in Europe
• Explain the changes in the legal framework of pharmaceutical legislation in their companies
• Participate in an interactive way at the the DIA Euromeeting session dealing with new legislation, e.g. clinical trials legislation and the falsified medicines directive. Participants should be able to recognise recent case law of the Court of Justice and the General Court.
• Non-lawyers who work in a legal environment from industry, government agencies and competent authorities
• Lawyers from industry, government agencies and competent authorities who have recently started in this position