概要

This training course provides description and discussion of the complete spectrum of necessary regulatory procedures: marketing authorization registration procedures, variation procedures, renewal procedures and more. Expert instructors use practical examples and experiences to illustrate procedures. The course focuses on Europe but also reviews regulations in other regions including the US and Japan.
Course Level: Intermediate

何を学ぶか

Drug Regulations
Role of Regulatory Affairs in Drug Development / Approval / Marketing
Registration Dossier
Regulatory Strategy
Variations: The Role of Regulatory Affairs after Marketing Authorization
Transparency in Drug Regulatory Affairs

参加対象

This course provides the knowledge and tools for experts and managers from the regulatory agencies and pharmaceutical industry working in the areas of:

学習目的

At the conclusion of this course, participants should be able to:

Define the drug legislation and regulation with a focus on the EU
Demonstrate successful knowledge of the Internet to locate relevant documents
Identify the key functions of regulatory affairs during the different phases of a drug life cycle
Formulate successful regulatory strategies and apply it to the product concerned

European Regulatory Affairs: Keeping Your Finger on the Pulse of Marketing Authorizations

概要

何を学ぶか

参加対象

学習目的

最新情報や機会を逃さないで