News

November 2021
Real Regulatory Tips and Insights

published 2 Dec 2021

Since the 2020, we have published weekly Regulatory tips and insights from our Regulatory experts on our Real Regulatory LinkedIn page, as a service to our followers. The tips we published in November 2021 are collected here, for convenience. Make sure you follow  Real Regulatory Ltd and Real CMC for regulatory news, reports and hints.

Clinical Trials Submissions in the UK

https://www.hra.nhs.uk/planning-and-improving-research/policies-standards-legislation/clinical-trials-investigational-medicinal-products-ctimps/combined-ways-working-pilot/

 

MHRA and OECD Guidance on Data Integrity Requirements

 

Updated Q&A on the Mandatory Use of OMS for CAPs

http://esubmission.ema.europa.eu/eaf/eAF_1.25.0.0/OMS%20Mandatory%20CAPs%20QandA.pdf

 

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