News

May 2022
Real Regulatory Tips and Insights

published 3 Jun 2022

Please find below a roundup of our weekly Regulatory Tips and Insights from our Regulatory experts on our Real Regulatory LinkedIn page. The tips we published in May 2022 are collected here, for convenience. Make sure you follow Real Regulatory Ltd and Real CMC for regulatory news, reports and hints.

Clinical Study Reports and the ICH Template

https://database.ich.org/sites/default/files/E3_Q%26As_R1_Q%26As.pdf

Clinical Trials: Substantial Amendments

EMA Guidance on CSR Signatures and Appendices

https://www.ema.europa.eu/en/documents/scientific-guideline/note-guidance-inclusion-appendices-clinical-study-reports-marketing-authorisation-applications_en.pdf

https://www.ema.europa.eu/en/documents/scientific-guideline/note-guidance-coordinating-investigator-signature-clinical-study-reports_en.pdf

EMA QRD Guidance Documents

https://www.ema.europa.eu/en/human-regulatory/marketing-authorisation/product-information/product-information-reference-documents-guidelines