Director Paul Calvo was a speaker on the “Transcontinental Update on Regulatory and IP Strategies Surrounding Clinical Trials” panel session at the Life Sciences Strategy Summit on IP & Exclusivity 2024 hosted by Kisaco Research.
Session Overview
The importance of clinical trials for life science regulatory and intellectual property departments is multifaceted, involving a complex landscape of regulatory pathways, IP laws, and market considerations. This expert and multi-stakeholder panel session provided attendees with an update from regulatory experts and in-house/ private practice IP attorneys from the USA and Europe. By joining, attendees learned the core legal questions regarding clinical trials for your company.
- What is the impact of G2/21 (and subsequent decisions on “plausibility”) for IP and regulatory strategies concerning clinical trials?
- How will the EPO and the UPC handle the standard of disclosure for clinical trials?
- What regulatory approval considerations must be applied to clinical trials and what is the impact of the clinical trials regulation (No 536/ 2014) and the revised and the revised CTIS transparency rules?
- What are the differences between USA and European clinical trial regulations and IP strategies?
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