Advisor 469

CLINICAL RESEARCH • CLINICAL QUALITY ASSURANCE

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guidance includes some additions relating to the situation with Northern Ireland and a more time-restricted acceptance of EU batch testing and release. The ABPI will continue to seek more engagement with the UK government in these areas. Richard Torbett (Chief Executive of the ABPI) said, “Companies face significant changes in how the complex environment for medicines regulations will operate in 2021. If we are to ensure uninterrupted supply for the NHS [National Health Service] from January, the MHRA must continue to work closely with them on details related to individual medicines as well as on issues related to the Northern Ireland Protocol and on other areas of regulation.” The ABPI added that companies are still waiting for the MHRA to provide additional technical u

information on issues such as • the handling of decentralised and mutual recognition procedures • how variations to marketing authorisations will be handled • new assessment routes • detailed guidance on the regulation of medicines in Northern Ireland. Even with the new guidance, pharmaceutical companies will face a significant change in the way they operate and will have to work through the practicalities of implementing the requirements. The MHRA will need to be available to work through the detail on an individual-company basis, given the complexity of medicines regulation.

Source: < ://tinyurl.com/y2w698j4>,

CTTI shares best practices for conducting trials during COVID-19 The Clinical Trials Transformation Initiative (CTTI) has published a set of best practices help researchers adapt to the changing clinical trial landscape and conduct successful studies during the pandemic.

The CTTI, a public–private partnership co-founded by Duke University and the FDA, seeks to develop and drive the adoption of practices that will increase the quality and efficiency of clinical trials. Recognising the huge impact of the COVID-19 pandemic on the conduct of clinical trials, the CTTI is considering ways to help the industry (and therefore patients) to move forward. The CTTI has conducted a series of initiatives to help the research community deal with the challenges associated with adapting trials during the pandemic, and has captured eight best practices in a new document, ‘Best Practices for Conducting Trials During the COVID-19 Pandemic’. The CTTI gathered experiences and learnings via

public surveys and discussions, and communicated these findings during two CTTI-hosted webinars. The new best practices document includes detailed information on how stakeholders can best integrate these important recommendations into their ongoing clinical trials. It also refers to and provides links to several additional resources to fully support these efforts, most notably to the ‘FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Public Health Emergency’, which was most recently updated on 2 July 2020. Keep participants informed The FDA guidance introduced in response to the pandemic notes that, “It is critical that trial

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Issue 469, 2020

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