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Julia Gillert

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Julia joined Baker McKenzie's London office as a trainee in 2005, qualifying in 2007, with a secondment to the Singapore office, and has shaped her practice to focus exclusively on regulatory matters affecting the Healthcare & Life Sciences industry.

Explore Data PULSE, a platform which helps you to navigate the complex landscape of data, regulatory and IP protection concerns at each stage of the medical product life cycle. As you navigate through each key issue, Data PULSE will help you to identify and mitigate risks across multiple jurisdictions and optimize your strategy through research, market authorization and post-market study phases.

The Medicines & Healthcare products Regulatory Agency launched a consultation in early 2022 as part of its post-Brexit efforts to develop a world-class and flexible regulatory environment for clinical trials. The consultation closed in March 2022, but continues to offer insights into what the future holds for the UK regime for clinical trials.

On 4 January 2022, the new UK foreign investment review regime under the National Security and Investment Act 2021 came into force. The new rules require businesses and investors to submit mandatory notifications for certain acquisitions of, and investments in, companies active in 17 key sectors of the economy. They also grant the Government extensive powers to investigate and impose conditions on a wide range of transactions (including both corporate investments and asset transactions) on national security grounds.

NICE has produced a single guidance development manual, which describes how NICE conducts itself with each step and stage in its evaluation (NICE’s processes) and how NICE collects and considers evidence (NICE’s methods). The guidance development manual covers: Diagnostic Assessments Programme, Medical Technologies Evaluation Programme, Highly Specialised Technologies Evaluation Programme, Technology Appraisal Programme.

The UK’s Early Access to Medicines Scheme (EAMS) gives patients with life-threatening or seriously debilitating conditions access to medicines that do not yet have a marketing authorisation, when there is a clear unmet medical need. The existing EAMS began in 2014 and since then has granted 100 medicines a Promising Innovative Medicine (PIM) status and more than 40 Scientific Opinions have been awarded in a variety of therapeutic areas with unmet patient need.

Join our webinar on Thursday, 20 January 2022 for an engaging discussion on trade compliance, customs laws and risks of sanctions within the cannabis industry. Our panel of legal experts in international trade compliance will discuss such topics as: what the cannabis industry can do to be more trade compliant, how to navigate the multi-jurisdictional variances in customs laws, how to reduce the risks associated with the import and export of cannabis and how to identify and mitigate sanctions risks.

The Heads of Medicine Agency has published a letter highlighting its plans to collaborate with other European medicines agencies to build knowledge on the approaches taken by member states with a record of effective, consistent trial reporting, with a view to sharing guidance with all member states as to “best practice” clinical trial reporting ahead of the new Clinical Trial Regulation and enhanced transparency rules coming into force. This article sets out the reasoning behind the letter’s publication, as well as an overview of key provisions within the CTR.