Webinar

Optimising Patent Strategies Under the Revised EU Clinical Trials Regulation Transparency Rules

Published 12th November 2024

Patent Filing Considerations in View of Revised Clinical Trial Regulation Transparency Rules

Is your patent strategy ready for the new transparency requirements of the EU Clinical Trials Regulation?

Join us for an exclusive webinar, co-hosted by J A Kemp and DLRC. We dive into the intellectual property challenges posed by the transparency requirements of the EU Clinical Trials Regulation.

Presenters Karen Ng and James Biddlecombe share expert insights on how to navigate patent filing complexities. Learn why early engagement and seamless collaboration between legal and regulatory teams is crucial for making the most patent opportunities throughout the lifecycle of clinical trials.

 

Meet the experts

aren Ng, Associate, European and UK Patent Attorney, J A Kemp
Karen Ng

Associate, European and UK Patent Attorney, J A Kemp

Karen plays an active role in advising and managing patent portfolios for a wide variety of clients from startups to large multinational corporations. In particular, she has experience of managing large, complex portfolios of patent families. This includes those covering clinical candidates and platform technologies. She has expertise across a wide range of disciplines, including cell and gene therapies, antibodies, vaccines, biomarkers, and diagnostics. Karen is based in J A Kemp’s Oxford office.

Contact Karen
James Biddlecombe Business Transformation and CTR Lead DLRC Ltd, DLRC Group
James Biddlecombe

Business Transformation and CTR Lead, DLRC Ltd, DLRC Group

James’s journey with the EU CTR started in 2017, working at the EMA in the CTIS business team. In this time, he supported the development of the regulation and guidance, the development of CTIS, and has supported clients with CTR readiness and CTA submissions. He has supported numerous clients in getting them ready for the CTR Go-Live through training, redesign of operating models, and updates to processes and procedures. More recently, he supports clients with strategic direction for trials submitted under the CTR and helps to navigate EU CTR guidelines and ensure CTA document compliance with the regulation.

Contact James

Want to dive deeper?

Also written in partnership with J A Kemp, our whitepaper provides a deep dive into patent filing considerations and highlights the importance of engagement and co-ordination of the legal and regulatory teams early on, and throughout the life cycle of clinical trials, to optimise patent filing opportunities.

Read more
Whitepaper - Patent Filing Considerations in View of Revised Clinical Trial Regulation Transparency Rules

Are you prepared for the new Clinical Trials Regulation?

The EU Clinical Trials Regulation (CTR) entered into force on 31 January 2022 and became mandatory for all new applications from 31 January 2023. Speak to us today to make sure you are ready for the new regulation.

 

Stay Informed

Sign up to our bimonthly newsletter for the latest news and industry insights

    Please check this box to submit the form and agree to communications from DLRC and the storage and handling of your data, in accordance with our Privacy Policy.

    Thank you for your submission.

    Latest news

    View all