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Nouveaux modèles de convention unique pour la recherche clinique: plus de standardisation, moins de simplification

De nouveaux modèles de convention unique pour la recherche clinique ont été publiés le 5 aout 2024. Ceux-ci mettent à jour les précédents modèles en prenant en compte les nouvelles tendances de la pratique en matière de...more

New French template agreement for clinical trials: more standardization, less simplification

Two updates to the French national clinical trial template agreements (Convention Unique) were published on August 5, 2024. They update the previous templates to take into account evolving practices in clinical trials. In...more

Q2/2024 Life Science Law Update – Key developments for pharma & device companies in EU

The Q2/24 Life Science and Health Care Law Update covers key trends in the EU and Big Five (France, Germany, Italy, Spain, UK) in life sciences regulatory, corporate, compliance, competition, and privacy....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

World Stem Cell Summit panel compares global trends in regenerative medicine regulations

Speaking at the World Stem Cell Summit hosted by the Regenerative Medicine Foundation, Hogan Lovells partners Mike Druckman, Ernesto Algaba, Mandi Jacobson, Lu Zhou, Mikael Salmela, Charlotte Damiano, and Lowell Zeta, along...more

Key legal concerns for advanced therapy medicinal product (ATMP) sponsors in Europe

In recent years we have seen more and more gene and cell therapies coming successfully to market – but many more such candidates have not made it to market, or been unable to obtain sufficient reimbursement. Gene and cell...more

Long-awaited update of the French “Convention Unique” for clinical trials finally published

A new French template agreement for clinical trials (Convention Unique) was published on April 9, 2022. This new version was much awaited since the initial version, dated back to 2016, was missing some key provisions...more

Life Sciences and Health Care Horizons - 2021

Companies in the life sciences and health care industry, like most companies, navigated unparalleled challenges in 2020. But unlike other industries, they had to do so while simultaneously facing the biggest challenge of all...more

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