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Project Management for Regulatory Affairs Professionals

Utilise project management techniques to streamline your regulatory procedures

23 - 24 November 2020

Radisson Blu Edwardian Grafton, London

The role of regulatory affairs has evolved over time to one that requires skills and competencies usually associated with project management. Regulatory professionals are required to manage cross-functional teams, set timelines and manage documentation. They must do all of this in a regulatory environment which adds a unique set of challenges when compared to standard projects.  
This course will provide you with an understanding of how project management principles and tools can be applied, allowing you to proactively plan for evolving timelines and requirements, engage stakeholders and combat resistance to change, streamline documentation requirements and more. You will learn using a combination of trainer-led presentations and group discussions to consolidate what you have learned. There will also be additional time for you to discuss the implications of Brexit on this subject matter. 

  •  Discuss core project management principles and building a project procedure
  • Understand how project management can best be applied to regulatory affairs
  • Examine how to manage your regulatory team as a project manager, and how to influence and communicate with cross-functional teams
  • Consider management of timelines, including tools for project planning and strategies for managing global regulatory timelines
  • Identify, understand and control risk to your project
  • Plan and streamline documentation for your project
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Dr Constanze Burkhardt

Constanze Burkhardt gained her PhD in neurobiology from the University of Muenster. She worked in project management roles in companies such as PAION Deutschland GmbH and Bayer, before joining PharmaLex, where she is now Senior Director for Strategic Outsourcing.

Constanze is currently responsible for numerous large-scale client programmes, leads inter-disciplinary project teams and regularly delivers consulting and training on strategic outsourcing and KPI development.

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

  • Regulatory Affairs Manager
  • Registrations/Submissions Manager
  • Product Manager

Attendees may also come from a project management background in other industries, and may benefit from a course focussing on the challenges facing the project manager in regulatory affairs, including:

  • Project Manager
  • Project Management Associate
  • PMO Associate
  • Project Management Officer

"I learned about the right techniques and tools that are recommended for a project to succeed. The fact that the trainer encouraged participation was great."

~ Regulatory Affairs, Pharmacovigilance manager, Dompé Albania

"Comprehensive summary of project management with several useful exercises in a shared environment. The content and trainer's performance was excellent."

~ General Product Lead, Sanofi

"Really interesting break-out sessions and discussions within the group."

~ Regulatory Affairs Manager, PharmaLex

I enjoyed the team exercises, feedback from trainer and colleagues. The course was well structured, and the trainer followed the agenda.

Regulatory Affairs Specialist, Bayer Consumer Care AG

I found the tools were very useful for managing a team.

Registration and Regulatory Affairs Specialist, Saudi Food and Drug Authority

I found the cluster concept, global roll out plans, project management tools and concepts particularly useful.

Pharmaceutical Affairs Officer, Generis Farmaceutica S.A.

This course was well suited to my job responsibility. I enjoyed the open discussions and experience sharing.

Senior Coordinator - Global Regulatory Affairs, Ipsen

I enjoyed that there were lots of team exercises.

Regulatory Affairs Officer, Kiadis Pharma

The fact that there was a small, interactive group was great. The knowledge of the trainer, diverse backgrounds/experiences shared from other participants was useful.

Regulatory Affairs Specialist, BAYER

The experience was very interactive. I could experience how people in other companies and varied countries perform.

Regulatory Affairs Officer, HAL Allergy Group

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