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.
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:
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:
"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.
I found the tools were very useful for managing a team.
I found the cluster concept, global roll out plans, project management tools and concepts particularly useful.
This course was well suited to my job responsibility. I enjoyed the open discussions and experience sharing.
I enjoyed that there were lots of team exercises.
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.
The experience was very interactive. I could experience how people in other companies and varied countries perform.