Early engagement with regulators is a key success factor in the delivery of early-phase clinical research. Proactive, early engagement via Regulatory Scientific Advice can mitigate risk with your CTA package further down the line.
Dr Kirsty Wydenbach is Head of Regulatory Strategy at Weatherden, and also a member of our independent Drug Development Advisory Board. She has over 13 years’ experience as an Expert Medical Assessor at MHRA within the Clinical Trials Unit. Kirsty was also involved in the UK regulation of clinical trials across all therapy areas and all phases of development, including ATMPs and many first-in-man studies and was previously an EMA expert for the update of the First-in-Human guideline.
We were thrilled when she agreed to present as part of our half-day seminar, Turning Science into Medicine: Operationalising a Complex Early Clinical Trial in February 2024, and we are delighted to share that you can now watch her presentation on-demand.
Access now to gain:
- An understanding of Regulatory Scientific Advice
- Insight into the value of early communication with Regulators
- An appreciation of the common pitfalls when seeking formal Regulatory Agency feedback.