News

September 2021
Real Regulatory Tips and Insights

published 14 Oct 2021

Since the beginning of July 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 September 2021 are collected here, for convenience. Make sure you follow  Real Regulatory Ltd and Real CMC for regulatory news, reports and hints.

Updated MHRA Guidance on Access to Electronic Health Records

 

Mandatory use of OMS in eAF for all EMA Submissions

http://esubmission.ema.europa.eu/index.htm

 

 

RPI Number and PIP Submissions to EMA

https://www.ema.europa.eu/en/human-regulatory/research-development/paediatric-medicines/paediatric-investigation-plans/paediatric-investigation-plans-questions-answers#1.-applying-for-a-pip,-waiver-or-deferral-section.

 

UK Clinical Trials Submissions

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

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