Regulatory Strategy and Regulatory Procedures Training Modules

Selecting a route to registration, particularly on a global scale depends on many factors.  These modules provide training on Regulatory Affairs activities, the legislation and procedural aspects to help answer questions such as: Which procedure should I follow to get a Marketing Authorisation?

Modules on Regulatory strategy and Regulatory Procedures include:


The Legal Framework in the EU LEG01
Overview of Key Components of the Current EU Legislation for Pharmaceuticals LEG02
The Legal Framework and Regulatory Authorities - US LEG03
The Legal Framework - EU vs US LEG04
Global Introduction to Regulatory Affairs - Agencies and Legislation LEG05
Regulatory Aspects of the Drug Development Process REG01
EU Regulatory Environment - Overview REG02
Regulatory Affairs and its Role in the Organisation REG03
Overview of EU Procedures MAPROC01
Types of Application in the USA - INDs and NDAs MAPROC02
EU Regulatory Strategy Part 1: Defining the Product STRAT01
EU Regulatory Strategy Part 2: Input into the Development Plan STRAT02

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