📢 Monday Weekly Summary: Stay informed with the latest regulatory updates!
In the fast-paced world of regulations, staying updated is key to success. We’ve gathered a comprehensive list of regulatory updates from last week (19.08 – 25.08.2024) to keep you informed about the latest changes in the pharmaceutical industry. Check out the links below for essential insights and ensure compliance with the ever-evolving landscape.
🌟 Scientific Articles
📝 Recommendations/Regulations/Guidelines/Instructions/FAQs
The ICH E11A Guideline reaches Step 4 of the ICH Process
Clinical Trial Information System (CTIS) – Sponsor handbook
📖 Reports
Report – Follow up EMA and EORTC multi-stakeholder workshop on soft tissue and bone sarcoma
💡Trainings/Presentations/Invitations
AI in Drug and Biological Product Development
2024 08 21 What’s New with MedDRA V27.1 and the MSSO
2024 08 22 What’s New with MedDRA Version 27.1 and the MSSO
📰 News/Press Releases
N/A
🗓️ Meeting agendas/minutes/summary
Minutes of the COMP meeting 18-20 June 2024
Minutes of the PRAC meeting 10-13 June 2024
Agenda of the CHMP written procedure 19-22 August 2024
📋Product opinion/decisions/updates
Metamizole-containing medicinal products – referral
Privigen – direct healthcare professional communication (DHPC)
NovoSeven – direct healthcare professional communication (DHPC)
📚 Other
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