Quotable: Top Experts On Policy Hot Topics

The Pink Sheet highlights recent comments and insights from pharma officials and executives on key issues we are covering.

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“The goal now is that for every ICER review, we are going to consistently evaluate the clinical trial diversity and give a rating of either good, fair or poor on clinical trial diversity.” – Foluso Agboola of the Institute for Clinical and Economic Review in the US. Find out more: ICER Debuts Clinical Trial Diversity Assessment Framework

“We're trying to come up with any solutions that we think could make 2025 smoother, but it's reasonable to expect...

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Quotable: Top Experts On Policy Hot Topics

 

The Pink Sheet highlights recent comments and insights from pharma officials and executives on key issues we are covering.

WHO To Finalize Preferred & Critical Characteristics Of New Mpox Human Vaccines

 
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To help sponsors developing candidate mpox vaccines, the World Health Organization will soon be finalizing guidance on the preferred and minimum characteristics these products must satisfy regarding efficacy, dose regimen and other aspects to secure regulatory approval.

WHO Urges Countries To Curb Spread Of Mpox With Vaccines, Therapeutics & Other Actions

 
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The WHO’s emergency committee has warned of a lack of understanding of the epidemiology of mpox, the limited availability of vaccines, and the complexities of donations and procurement.

ICH Explores New Platform To Facilitate Global Evaluation Of CMC Changes

 
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An ongoing collaborative initiative involving global regulators assessing post-approval manufacturing changes has highlighted the need to establish a standardized platform that can facilitate the submission and regulatory evaluation of such changes.

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Quotable: Top Experts On Policy Hot Topics

 

The Pink Sheet highlights recent comments and insights from pharma officials and executives on key issues we are covering.

Canada Cuts Red Tape With Single Ethics Review For Trials

A new research ethics review system for multi-site clinical trials in Canada is expected to help improve study start-up times, avoid unnecessary duplication and boost the country’s competitiveness on a global stage.

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