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 February 2023 are collected here, for convenience. Make sure you follow Real Regulatory Ltd and Real CMC for regulatory news, reports and hints.
Digital Application Dataset Integration (DADI) project – web-based variation form for human medicinal products launching in October 2022
eTMF Quality Control and Audit Preparation Advice
Industry Single Point of Contact (i-SPOC) Registration Required
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 January 2023 are collected here, for convenience. Make sure you follow Real Regulatory Ltd and Real CMC for regulatory news, reports and hints.
Importing investigational medicinal products (IMPs) into Great Britain from an approved country – end of transition period
IRIS-Scientific Advice
Transferring a Research Product Identifier (RPI) in IRIS
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 December 2022 are collected here, for convenience. Make sure you follow Real Regulatory Ltd and Real CMC for regulatory news, reports and hints.
MA Holder & Delegated Activities
Questions & Commitments from Prior Submissions
EMA QRD Guidance Documents
EMA Christmas Closure
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 November 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
EMA guidance on CSR signatures and appendices
Clinical Trial Comparators
Clinical Trials: Planning for EU sites
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 October 2022 are collected here, for convenience. Make sure you follow Real Regulatory Ltd and Real CMC for regulatory news, reports and hints.
Clinical Trials: Substantial Amendments
eVariation eApplication Forms
Clinical studies and sponsor responsibilities
Submission of renewals to HPRA
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 September 2022 are collected here, for convenience. Make sure you follow Real Regulatory Ltd and Real CMC for regulatory news, reports and hints.
New Role in IRIS
eAF for Variations and the Classification Guidelines
QPPV Details Update for UK National Licences
MHRA to retire eSUSAR Website
EU CTIS – Part II Doc Required for Part I Only Submission
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 August 2022 are collected here, for convenience. Make sure you follow Real Regulatory Ltd and Real CMC for regulatory news, reports and hints.
EMA eSubmission Gateway Web Client-Upgraded Syncplicity Portal
Clinical Studies & Sponsor Responsibilities
Mandatory Use of OMS in eAF for all EMA Submissions
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 July 2022 are collected here, for convenience. Make sure you follow Real Regulatory Ltd and Real CMC for regulatory news, reports and hints.
MA & Variation eApplication Forms
Questions and Commitments from Prior Submissions
Variation eApplication Forms
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 June 2022 are collected here, for convenience. Make sure you follow Real Regulatory Ltd and Real CMC for regulatory news, reports and hints.
Clinical Trials Comparators
Marketing Authorisation Application Form
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
EMA QRD Guidance Documents