Guidance to sponsors on how to manage clinical trials during the COVID-19 pandemic

Guidance to sponsors on how to manage clinical trials during the COVID-19 pandemic

BioResearch is following  new recommendations for sponsors on how to manage the conduct of clinical trials in the context of the coronavirus disease (COVID-19) pandemic, published by  The European Commission, the European Medicines Agency (EMA) and national Head of Medicines Agencies (HMA). Please click below link for details.

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News

Clinical research reshapes nicotine regulation - BRG article in ITJ

upcoming publication by Dr. Katarzyna Jarus-Dziedzic, on the increasing importance of clinical studies in the Tobacco Market

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Data Quality at the Center of Regulatory Attention – the BRG Standard

In recent months, regulators have placed an even stronger emphasis on data quality in clinical trials.

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Regulatory change across the European Union

Flavoured heated tobacco (HnB) sticks withdrawn from sale as of 18 January 2025

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Novel Nicotine Products Under Increasing Regulatory Pressure. Safety Studies Become a Key Pillar

Novel Nicotine Products Under Increasing Regulatory Pressure. Safety Studies Become a Key Pillar of Market Authorization

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