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Van Bael & Bellis | European Union | 2 Oct 2023
European Commission Updates Q&A on EU Clinical Trials Regulation
On 29 September 2023, the European Commission published a newly updated version of its Q&A on the EU Clinical Trials Regulation (i.e., Regulation…
Taylor Wessing | European Union, Germany | 25 Sep 2023
Aktuelle Entwicklungen im Bereich klinischer Arzneimittelstudien in Deutschland - Stellschrauben zur Verkürzung der Verfahrensdauer vor Beginn einer klinischen Studie
Klinische Studien sind ein essentieller Baustein in der (Weiter-) Entwicklung von Arzneimittel und der Erforschung von Krankheiten. Sie tragen nicht…
Taylor Wessing | European Union, USA | 21 Sep 2023
The Long and Winding Road: (Some) EU and FDA Issues to Consider with Clinical Trials and Clinical Trial Agreements
In this webinar, AGG Food & Drug co-chair Alan G. Minsk and Taylor Wessing Life Sciences and Healthcare attorneys Dr. Manja Epping and Irina Rebin…
Covington & Burling LLP | USA | 18 Aug 2023
Seven Opportunities for Stakeholder Engagement on FDA Draft Guidance Proposing Updates to Good Clinical Practice Guidelines
On June 6, 2023, the U.S. Food and Drug Administration (FDA) issued a draft guidance entitled E6(R3) Good Clinical Practice (GCP) (hereinafter…
Han Kun Law Offices | China | 27 Jul 2023
中国DCT（去中心化临床试验）的实施与监管
“以患者为中心”的理念已成为当前药物研发的核心指导思想。“以患者为中心”的药物研发是指基于患者角度开展的药物研发、设计、实施和决策的过程，旨在高效…
Mintz | USA | 25 Jul 2023
Why Pharma Companies Should File Patents Later In The R&D Process
Clinical trial related patent applications are often filed prior to the start of the Phase I clinical trial to minimize the risk of invalidation of…
Han Kun Law Offices | China | 17 Jul 2023
Key Takeaways of the new hgr guidelines
On July 14, 2023, the Ministry of Science and Technology of the PRC ("MOST") issued the Notice on Updating the Guidelines on Administrative Approval…
Han Kun Law Offices | China | 14 Jul 2023
解读新版人类遗传资源行政指南
2023年7月14日，科学技术部（下称“科技部”）发布了《关于更新人类遗传资源行政许可事项服务指南、备案以及事先报告范围和程序的通知》，公布了包括中国…
Mason Hayes & Curran LLP | European Union | 7 Jul 2023
Decentralised Clinical Trials in the EU: Key Considerations
Decentralised trials (DCTs) utilise digital and remote Technologies to facilitate clinical trials and collect data from trial subjects outside of…
Phillips Lytle LLP | USA | 1 Jul 2023
FDA Draft Guidance on Clinical Trials for Psychedelics
On June 23, 2023, the U.S. Food and Drug Administration (FDA) issued a draft guidance outlining clinical trial considerations for drug sponsors…
