RQA Newsletter 161

RQA Newsletter 161

News?

EMA - CTIS newsflash

EMA - Questions and Answers about the raw data proof-of-concept pilot for industry

EMA - Review of transparency rules for the EU Clinical Trials Information System (CTIS)

EMA - SME Office Newsletter 58

EMA - Statement from Emer Cooke on the end of the COVID-19 public health emergency

FDA - Additional Steps to Advance Decentralised Clinical Trials

FDA - Q9(R1) Quality Risk Management

MHRA - Good Manufacturing Practice Symposium 2023

MHRA - ICH E6(R3) Good Clinical Practice guidance - Step 2 Public Consultation

MHRA - Implementation of the Future Regulations

MHRA - Publication Scheme

MHRA Blog - Ensuring Child Vaccine Safety at Every Step

Swissmedic - Changes to the guidance document GMP compliance by foreign manufacturers and the form Declaration by the Responsible Person for foreign manufacturers

MHRA - Good Distribution Practice Symposium 2023

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