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Understanding the Impact of the New EU Artificial Intelligence Act on Clinical Research

Advarra

Artificial intelligence (AI) has taken the world by storm – and regulators are paying attention. These risks face fewer regulations but must meet certain standards to ensure ethical use. High Risk AI-powered Systems: Key Requirements The AI Act will likely consider many AI-based systems used in clinical trials today as “high risk.”

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A Look Back as the EU Clinical Trial Regulation Moves Forward

PPD

31, 2022, the EU Clinical Trial Regulation (EU CTR) 536/2014 became applicable, heralding a new era for clinical trials in the European Union (EU). In addition, the constant evolution of EMA and Clinical Trials Coordination Group (CTCG) guidelines requires constant attention.

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The Expansion of Cell Therapies in Asia-Pacific

PPD

There has also been an increase in government and regulatory support for CGT trials, in conjunction with an increase in investments for these products to get to market. The government has also enacted strict trade compliance policies that limit genetic materials, such as patient cells, leaving and entering China.

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The Trust Fall: Building Successful & Diverse Trials Outside the U.S.

H1 Blog

Breaking Down Barriers to International Clinical Trials Global Disruptions, Health Equity & Data Sharing As the U.S. When time is of the essence, like in a global pandemic, how do you scale trials internationally for success? Additionally, clinical trials are no longer confined to one country or region.

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Johnson & Johnson Announces Agreement in Principle with Government of Canada to Supply its COVID-19 Vaccine Candidate

The Pharma Data

Johnson & Johnson Announces Agreement in Principle with Government of Canada to Supply its COVID-19 Vaccine Candidate. Johnson & Johnson Announces Agreement in Principle with Government of Canada to Supply its COVID-19 Vaccine Candidate. The Phase 1/2a first-in-human clinical trial of the vaccine candidate, Ad26.COV2.S,

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Johnson & Johnson Announces Agreement with U.S. Government for 100 Million Doses of Investigational COVID-19 Vaccine

The Pharma Data

Government for 100 Million Doses of Investigational COVID-19 Vaccine. Government for 100 Million Doses of Investigational COVID-19 Vaccine. Company working to ensure broad global access to COVID-19 vaccine candidate, following approval from regulators. government may also purchase an additional 200 million doses of Ad26.COV2.S

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Coronavirus: Oxford University to resume vaccine trial after pause

The Pharma Data

Trials of a Covid-19 vaccine being developed by AstraZeneca and Oxford University will resume after being paused due to a reported side effect in a patient in the UK. Health Secretary Matt Hancock welcomed the news that the trials would resume. Image copyright. But on Saturday, the university said it had been deemed safe to continue.

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