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Zhong Lun Law Firm | China | 21 Dec 2022

临床研究合规管理探讨(下)

除针对临床参与方的合规管理外,申办者还需要建立完善的内部临床研究合规管理制度体系,以覆盖临床研究的全生命周期。…
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Zhong Lun Law Firm | China | 19 Dec 2022

临床研究合规管理探讨(上)

我国确立了基于风险启动药品注册核查检验的模式,2021年12月国家药品监督管理局药品审评中心发布《药品注册核查检验启…
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Bryan Cave Leighton Paisner LLP | Russia, USA | 28 Mar 2022

Medical Industry: Certain Clinical Trials Authorized

On March 24, 2022, the U.S. Department of Treasury’s Office of Foreign Assets Control (“OFAC”) updated General License 6 of Executive Order (“EO”)…
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Osborne Clarke | Spain | 24 Mar 2022

Clinical research and pharmacovigilance: Farmaindustria and AEPD's interpretation of data protection regulation

The novelties introduced in the Code of Conduct Regulating the Processing of Personal Data in the Field of Clinical Trials and other Clinical Research…
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DLA Piper | European Union | 26 Jan 2022

Initiative launched to accelerate EU clinical trials (ACT EU)

Accelerating Clinical Trials in the EU (ACT EU) was launched a few days ago, with the aim of transforming the way in which clinical trials are…
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Eversheds Sutherland (International) LLP | European Union | 12 Jan 2022

FAQs on EU CTR finally becoming applicable

The EU Clinical Trials Regulation (CTR) entered into force in 2014. Once it becomes applicable, it will repeal the existing EU Clinical Trials Directive and replace the system of nationally diverging rules for the assessment and conduct of clinical trials on medicinal products for human use with a regime that is largely harmonised across the European Union. This article looks at the key......
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Pinsent Masons | United Kingdom | 8 Dec 2021

Psychedelics: new frontier for mental health conditions?

Psychedelics are a group of medicines that alter mood and sensory perceptions, and – despite traditionally having mystical connotations – are now known to offer much-needed hope for many debilitating mental health conditions. This article provides a brief history of these medicines and discusses the prospect of them becoming a mainstream treatment for a range of psychiatric disorders in the......
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Bryn Aarflot AS | Global | 6 Dec 2021

Advantages of academic patenting

While the importance of patenting in various industrial fields is obvious to many, the significance of academic patenting remains more elusive. In academia, the focus has traditionally been on scientific publications, preferably in high-ranking journals. Patents have often been viewed almost as a nuisance. But as academic research scientists are now increasingly realising, there is a lot to......
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K&S Partners | India | 1 Dec 2021

Patent outlook: remodelling healthcare with AI

Artificial intelligence (AI) is causing a paradigm shift in the healthcare industry. The global patent publication trends show that research and development and patenting activity in AI/healthcare is expanding quickly. India is also emerging in this field, with an exponential surge seen from 2019 onwards in particular. This article provides an overview of the AI/healthcare patent landscape,......
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Danubia Patent and Law Office LLC | Hungary | 29 Nov 2021

Forthcoming amendment of Hungarian Patent Law

The Hungarian Parliament recently accepted a substantial amendment to the Patent Law. The amendment covers three important areas – namely, a broader interpretation of the Bolar exemption, an amendment of the rules concerning patent nullity proceedings relating to patent infringement lawsuits and a slight amendment of the conditions connected with preliminary injunction proceedings. This......
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