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UK’s MHRA To Offer Private Meetings For Innovative RWE Strategies

 
• By Eliza Slawther

The MHRA’s new scientific dialog program will offer drug developers “closed-door meetings” that will offer “confidential, commercially sensitive discussion” with its staff to help them “refine” their real-world evidence generation strategies.

A new real-world evidence (RWE) program, set to be launched by the UK’s Medicines and Healthcare products Regulatory Agency, will see innovative drug developers benefit from private meetings with representatives from the agency and England’s health technology assessment (HTA) body, NICE.

A pilot version of the RWE scientific dialog program will begin this year, and an MHRA spokesperson told the Pink Sheet that it “anticipate[s] offering approximately four closed-door, confidential meetings...

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The International Council for Harmonisation has identified four new topics that can benefit from global regulatory alignment, with timelines for initiating work to be determined later.

UK MHRA’s Clinical Trial Lead On Combined Reviews, The Notification Scheme & Increasing Diversity

 
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Why Successful Companies Are ‘Tough On Themselves’ When It Comes To HTA

 
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UK’s International Recognition Procedure: EU Dossier Faster Than US Or Canada

 
• By Eliza Slawther

Companies that use the European Medicines Agency as a reference regulator for the UK’s International Recognition Procedure can expect a faster approval than those that use other national regulators, such as those in the US and Canada, an MHRA spokesperson has said.

Industry On Making England’s HTA Innovation Lab A Success

 
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UK Health Data Research Service Looks ‘Encouraging’ For Industry, But Implementation Details Will Be Key

 
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