📢 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 (12.08 – 18.08.2024) 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
- Caveats of Covariate Adjustment in Disproportionality Analysis for Best Practices
- Unveiling the Burden of Drug-Induced Impulsivity: A Network Analysis of the FDA Adverse Event Reporting System
📝 Recommendations/Regulations/Guidelines/Instructions/FAQs
- Guide to CTIS training material catalogue
- Questions and answers on the impact of mutual recognition agreement between the European Union and the United States as of 7 August 2024
- Scientific advice and protocol assistance adopted during the CHMP meeting 22-25 July 2024
- EudraVigilance: how to register (Related documents update)
- IRIS guide for applicants – How to create and submit scientific applications, for industry and individual applicants
- Biological and chemical threats
- Clinical Trial: appeal procedure – guideline from Polish HA
- Questions and answers relating to Grant Procedure no. EMA/GRANT/2024/02/IA – Medicines regulatory systems strengthening in Sub-Saharan Africa
- Submit a Standardized Data Sample to FDA
- eCTD Submission Standards for eCTD v4.0 and Regional M1
- FDA Announces Milestone in Sodium Reduction Efforts, Issues Draft Guidance with Lower Target Levels for Certain Foods
📖 Reports
- N/A
💡Trainings/Presentations/Invitations
- Clinical Trials Information System (CTIS): online training modules
- What is Accelerated Approval?
- How are Cancer Drugs Approved?
📰 News/Press Releases
🗓️ Meeting agendas/minutes/summary
📋Product opinion/decisions/updates
- Glatiramer acetate DHPC
- List of medicines currently in PRIME scheme
- List of signals discussed at PRAC since September 2012
📚 Other
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