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New development for clinical trial agreements in Germany: Proposal of standard contractual clauses from 21.02.2025

Key takeaways Faster Negotiations: SCs aim to significantly shorten CTA review times. Scope: The SCs cover specific terms, such as ownership of study results, publication rights, liability limitations, and termination...more

Negotiating cell, tissue, and gene therapy agreements with health care organizations

Legal challenges for innovative cell, tissue, and gene therapies (CTGTs) are mainly seen in the still evolving regulatory environment. However, it is also crucial for the manufacture and supply of CTGTs to have agreements in...more

The use of IVDs as CDx in pharmaceutical clinical trials - Pathways for legacy companion diagnostic IVDs, IVD performance studies,...

The current European legislation for in vitro diagnostic medical devices (IVD) (Regulation 2017/746 or the IVDR) has created challenges not only for IVD manufacturers but also for pharmaceutical companies....more

Medizinprodukte Update 2022

Bei unserem Medizinprodukte Update Webinar im November 2022 haben die Partner:innen Dr. Jörg Schickert, Arne Thiermann und Dr. Tanja Eisenblätter, sowie Associate Dr. Benjamin Goehl den Teilnehmenden Updates zu einer Reihe...more

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