Regulatory Change: Biosimilars, Trials, Redaction

Regulatory Change: Biosimilars, Trials, Redaction
Regulatory expectations are evolving fast. Join tranScrip for a practical webinar designed to help regulatory professionals stay ahead of change, reduce risk and make more confident decisions. Our experts will explore the comparability of biosimilars, the evolution of the UK clinical trial framework, and how to author documents that are redaction ready. With focused insights and real-world perspectives, this session will equip attendees with timely knowledge they can apply immediately across development, submission and regulatory writing.

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Date: Thursday 22 April 2026
Time: 13:00 - 14:00 GMT


What you'll learn

  • Comparability of biosimilars
  • Evolution of UK clinical trial framework
  • Authoring documents to be redaction ready

Who should attend

Pharmaceutical Companies:  Emerging Biotech’s and medium pharma 
Key Decision-Makers:  C-suite – CEO, CSO, CMO, COO as well as regulators and medical writers. 

Webinar host & presenters


   Host: Judi Proctor
Head of Medical Writing, tranScrip
 Judi is a principal medical writer, with a focus on clinical regulatory writing and is one of our senior project managers. Judi has expertise in the entire product life cycle for large and orphan indications across a wide range of therapeutic areas, including oncology, infectious disease, respiratory and internal medicine. Judi has led the writing of a number of INDs, NDAs and MAAs to successful submission.
    Speaker: Lucy Herlihy
Director, Regulatory Affairs at tranScrip
 With over 25 years’ industry experience including clinical data management and regulatory affairs, specialising in management and oversight of European and UK Clinical trials, regulatory strategy and regulatory intelligence. Following roles in consultancies and CROs, she joined the tranScrip group in 2010. Lucy is highly experienced in managing multiple clients and complex projects, delivering efficient, high-quality services. She supports client relationships, project oversight, and internal training. Lucy holds a Microbiology degree from University College Cork.



  Speaker: Richard Francis
Senior  Consultant, CMC & Quality

An accomplished professional 40 years + with specialist experience in CMC activities covering development, manufacturing, analytical testing / characterisation, and regulatory agency interactions. This applies to many product types such a monoclonal antibody (all variant types), nanobodies, Vaccines, Cell and gene therapy products, recombinant proteins and biosimilars. Richard is well versed in all relevant regulations and have conducted many training sessions in multiple companies covering ICH and related regulations. Have guided and been part of many product submissions and regulatory agency interactions including face to face meetings and on-site Pre Approval Inspections. 
 
When
22/04/2026 13:00 - 14:00
Where
ONLINE
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