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Informa
TBC in 2021

2-day course

Expedite EU drug registration by integrating regulatory requirements in drug development

Course Overview

As a senior professional you must think strategically, aligning your regulatory knowledge to the wider organisational goals and objectives.  This is critical to maintaining compliance whilst managing budgets and keeping to strict business-critical deadlines.

This course has been designed to help you select the best registration strategy depending on the product area and indication. Submissions are delayed because of a lack of CMC / non-clinical / clinical data, inaccurate indications being submitted, and inappropriate procedures being used. The financial consequences are potentially devastating.

This interactive 2-day course will provide you with practical information on effective drug registration processes; best practices for integrating regulatory requirements from early stages of development; advice on how to develop RA project teams; and, strategies that work for both you and the regulators.

What will you learn?


Registration procedures
Registration procedures

Speed up drug registration through skilled utilisation of registration procedures

MAA/CTD submissions
MAA/CTD submissions

Manage the practical hurdles of submitting MAA/CTD within the deadlines

How to work with regulators
How to work with regulators

Negotiate and respond to Regulators’ questions successfully


Data management
Data management

Collect and present key information for the submission dossier to achieve a winning strategy

Centralised, Decentralised and MR procedure
Centralised, Decentralised and MR procedure

Make the most out of the Centralised, Decentralised and MR procedure and get fast approval from Regulators

Who is this course for?

This course is relevant for anyone working within the field of regulatory affairs at management level or above, such as:

  • Regulatory Affairs Specialist
  • Regional Coordinator
  • Regulatory Affairs Associate
  • Development Pharmacist
  • Pharmacovigilance Manager
  • Regulatory Affairs Attorney
  • Regulatory Affairs Executive
  • Project Managers
  • Regulatory Affairs Manager
  • Strategy Management
  • Regulatory Affairs Officer
  • Quality Manager

CPD Certified

Engaging in Continuing Professional Development ensures that both academic and practical qualifications do not become out-dated or obsolete; allowing individuals to continually ‘up skill’ or ‘re-skill’ themselves, regardless of occupation, age, or educational level. This course has been assessed and is CPD certified.