Free for TOPRA members!
Sponsored by 
Date: Wednesday 18 November 2026
Time: 15:00 - 16:00 GMT
What you'll learn
Covering six key areas of biotech development, this session will provide practical guidance on moving from development strategy to First-in-Human (FIH) readiness. Explore development strategy, non-clinical package design, CMC strategy, clinical operations, Clinical Trial Application (CTA) requirements, and real-world regulatory case studies. The session concludes with a live Q&A.
By attending, you'll gain:
- A practical framework for aligning development strategy with your Target Product Profile and regulatory pathway
- The knowledge to design a fit-for-purpose non-clinical package and avoid common gaps that can delay CTA approval
- A clear understanding of CMC readiness for FIH and how to align CMC planning with clinical timelines
- Insight into the operational and governance foundations required before dosing the first subject
- Lessons from real-world regulatory case studies demonstrating how these principles are applied in practice
Who should attend
- Heads of Regulatory Affairs
- Heads of Clinical Operations
- Heads of CMC and Non-Clinical/Toxicology;
- Founders
- CEOs
- CSOs
- Program leads responsible for development strategy and investment decisions
- Consultants and CROs supporting early clinical development
Presenters
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Presenter: Angeles Escarti-Nebot
PhD – Global Head Regulatory Affairs, QbD Group
Angeles has 17+ years of experience across the full development lifecycle, from discovery through to marketing authorisation. Deep expertise in global regulatory frameworks (EMA, FDA, MHRA), including CTA/IND-enabling packages, scientific advice and expedited pathways. Specialised in biologics, ATMPs and complex products, integrating nonclinical and CMC with clinical strategies to de-risk development. End-to-end experience across academia, biotech, nonclinical CROs and consulting (Parexel, PharmaLex). PhD in Molecular Biology (cell & gene therapies), MSc in Neuropharmacology and Clinical Genetics, BSc in Pharmacy.
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Presenter: Sacha Lynch
Director Regulatory Affairs UK, QbD Group
Sacha has over 20 years of experience in European Regulatory Affairs. Background in Pharmacology and Medical Sciences, with a Master's degree in Clinical Research. Extensive experience supporting clinical strategy development and leading regulatory interactions, including Scientific Advice and MAA submissions. Currently Principal Consultant at QbD Group, supporting clients and leading project teams in clinical development strategy.
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Pricing
| Standard webinar registration fees |
| Webinar Registration Type |
Price (GBP) |
Standard Price
TOPRA Member |
FREE |
Standard Price
Non-member |
£60.00 |
If you are a non-member click 'Pay Later' on your payment option when booking. Your invoice will be issued by Xero to pay immediately or later.
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