📢 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 (13.05 – 19.05.2024) 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
- On-boarding of users to Substance, Product, Organisation and Referentials (SPOR) data services
- Template for Applicant’s responses to the questions raised by RMS and CMSs
- EudraVigilance registration documents
- EudraVigilance Form A
- New Organization First User QPPV/RP or Change of EU QPPV/RP
- Guidebook for tenderers
📖 Reports
- N/A
💡Trainings/Presentations/Invitations
- 2024 05 16 Standardised MedDRA Queries (SMQs)
- 2024 05 16 Advanced MedDRA Coding
- Clinical Trials Information System (CTIS) Bitesize Talk: Revised transparency rules and the new CTIS public portal
- Updated CAPs in web-based eAF information and Q&A session
📰 News/Press Releases
- N/A
🗓️ Meeting agendas/minutes/summary
- Agenda of the PRAC meeting 13-16 May 2024
- Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 13-16 May 2024
- Meeting Summary of the Medicine Shortages (SPOC) Working Party – 14 March 2024
- Minutes of the PRAC meeting 4-7 March 2024
📋Product opinion/decisions/updates
- Hydroxyprogesterone caproate medicines to be suspended from the EU market
- Referral: Hydroxyprogesterone caproate-containing medicinal products, hydroxyprogesterone caproate, associated names: Lentogest,Progesterone Retard Pharlon,Proluton Depot Article 31 referrals Recommendation provided by Pharmacovigilance Risk Assessment Committee, 17/05/2024
📚 Other
- European Medicines Agency’s data protection notice for the EMA Help Desk
- Organisation chart: Information Management
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