With our free networking sessions, you can air common challenges of working in our sector and learn from others’ experiences. You are welcome to attend!
Key focus areas
- Key regulatory procedures along the end-to-end product lifecycle(e.g. Regulatory Strategy
- Clinical Trials, Scientific Advice, Complex Submissions, Pre-Submission Meetings
- Inspection Readiness, Lifecycle Management)
- Key considerations and common practices in industry for these procedures.
What we offer
- Highly interactive sessions, in a safe environment to share issues, challenges and learning
- Peer to peer advice
- Tools and tips from expert facilitator(s)
Who should attend?
- Early career - drug development project managers / regulatory strategists
- Regulatory affairs submission managers
- Pharmaceutical industry, biotech, university
Benefits
- Sharing your own challenges with like-minded people
- Pick up some successful approaches from others and opportunity to ask questions
- Hear some tips from our expert moderator
- Elect to attend further sessions
Logistics and Costs
- 1-hour virtual session
- Free of charge (booking required)
- 8 – 16 participants
Regulatory Activities in Product Development – Key Concepts and Considerations in Europe
17th September 2025. 4-5pm (BST) – online session
In this Let’s Talk session key concepts and considerations will be covered under regulatory strategy and operational strategy.
For the regulatory strategy focus area the webinar will go over key activities per phase, regulatory pathways and wave strategies, how to collaborate with regulators (e.g. scientific advice).
We will be covering submission planning & execution for speed to market, inspection preparation / readiness and also post license maintenance as part of the operational strategy focus area.
Important to note that we will be focusing on topics chosen by the participants from the focus areas below. We aim to discuss issues participants have observed, possibly new developments and share common practices.
Moderator
Preeya Beczek (BSc Hons, MSc, cGB)
With an impressive 25 years of experience in the life sciences industry, Preeya Beczek has cultivated a robust track record of leading regulatory projects that span the entire product lifecycle within various therapeutic areas. Her expertise is marked by senior roles at leading firms like PAREXEL, GSK, Pfizer, JNJ, Ipsen, and DOW Chemicals, enhancing her ability to forge strong client relationships and broaden her professional network extensively.
Preeya excels in driving teams towards achieving key regulatory and compliance milestones set by executive leadership, showcasing her capability in both strategic planning and operational excellence. Her project highlights include labelling alignment, critical phase submission management, and inspection readiness for major regulatory bodies such as EMA and MHRA. Notably, her strategies facilitated the expansion of product regulatory frameworks into new EU markets, significantly shortened lead times for secondary packaging development by 30%, and enabled early product launches to outpace competitors.
Her role as a 'critical friend' makes her a prime facilitator among clients and cross-functional teams, where she employs her subject matter expertise to elevate team performance and process efficiency. Preeya is passionate about developing effective operational models, toolkits, and processes for Regulatory Affairs (RA) teams, enhancing global collaboration, data quality, and compliance.
Preeya holds a Bachelor of Science in Chemistry and Management Studies and a Master of Science in Environmental Strategy from the University of Surrey, UK. She is also a certified Lean Six Sigma Green Belt, which underscores her commitment to continuous improvement and operational excellence.
Preeya excels in driving teams towards achieving key regulatory and compliance milestones set by executive leadership, showcasing her capability in both strategic planning and operational excellence. Her project highlights include labelling alignment, critical phase submission management, and inspection readiness for major regulatory bodies such as EMA and MHRA. Notably, her strategies facilitated the expansion of product regulatory frameworks into new EU markets, significantly shortened lead times for secondary packaging development by 30%, and enabled early product launches to outpace competitors.
Her role as a 'critical friend' makes her a prime facilitator among clients and cross-functional teams, where she employs her subject matter expertise to elevate team performance and process efficiency. Preeya is passionate about developing effective operational models, toolkits, and processes for Regulatory Affairs (RA) teams, enhancing global collaboration, data quality, and compliance.
Preeya holds a Bachelor of Science in Chemistry and Management Studies and a Master of Science in Environmental Strategy from the University of Surrey, UK. She is also a certified Lean Six Sigma Green Belt, which underscores her commitment to continuous improvement and operational excellence.