PharmiWeb.com - Global Pharma News & Resources
29-Apr-2019 - 30-Apr-2019

EU Pharmaceutical Regulations & Strategy

  • Location:
    • Venue to be confirmed

This course will provide an up-to-date overview of the European pharmaceutical regulatory environment, procedures and obligations.

Course Overview

This course will provide an up-to-date overview of the European pharmaceutical regulatory environment, procedures and obligations. It will be of particular value as an introductory or refresher course for those involved in regulatory affairs or who interact with regulatory personnel to understand action time-lines and requests for information.

Benefits of Attending

  • Understand the Legal Basis of the EU Regulatory Environment
  • Discuss Development Strategy and Pre-Submission Activities
  • Review Procedures for Applying for a EU Marketing Authorisation
  • Discuss Post Authorisation Strategic Considerations and Obligations

Why you should attend

This course will provide an up-to date overview of the European pharmaceutical regulatory environment, procedures and obligations. You will learn about the legal basis of regulation, development strategies and the strategic importance of pre-submission actions, the format for presentation of data, how the registration procedures work and post authorisation strategies and obligations.

It will be of value for regulatory affairs personnel and also for those who interact with regulatory personnel in order to understand action time-lines and information requirements