📢 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 (15.07 – 21.07.2024) 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
- The PrescIT platform: An interoperable Clinical Decision Support System for ePrescription to Prevent Adverse Drug Reactions and Drug-Drug Interactions
- Accelerating clinical trials in the EU (ACT EU): transforming the EU clinical trials landscape. Nature Reviews Drug Discovery (Nat Rev Drug Discov)
📝 Recommendations/Regulations/Guidelines/Instructions/FAQs
- EudraVigilance – EVWEB user manual
- EudraVigilance registration manual
- Addendum to the Guideline on clinical development of vaccines to address clinical trials in immunocompromised individuals
- Nitrosamines EMEA-H-A5(3)-1490 – Questions and answers for marketing authorisation holders / applicants on the CHMP Opinion for the Article 5(3) of Regulation (EC) No 726/2004 referral on nitrosamine impurities in human medicinal products
- Q&A – Quarterly System Demo Q2 2024
📖 Reports
- Medicinal products for human use: monthly figures – June 2024
- Report – EMA multi-stakeholder workshop on psychedelics
💡Trainings/Presentations/Invitations
- ACT EU consolidated advice pilots: information and training webinar for Applicants
- ESMP Essentials and Industry Reporting Requirements Webinar – 24 June 2024
- FDA | NIH : Regulatory Do’s and Don’ts: Tips from FDA – 09/04/2024
- SPOR Status Update
📰 News/Press Releases
- CTIS newsflash – 12 July 2024
- FDA Roundup: July 16, 2024
- Using digital tools to achieve health for all
- The opportunities of using artificial intelligence in healthcare
🗓️ Meeting agendas/minutes/summary
- CHMP PROM minutes for the meeting on 15 April 2024
- Minutes of the COMP meeting 21-23 May 2024
- Agenda of the CAT meeting 17-19 July 2024
- PDCO minutes of the 28-31 May 2024 meeting
- Meeting summary – Medicine Shortages SPOC Working Party meeting on 22 May 2024
📋Product opinion/decisions/updates
- Emergency Task Force (ETF) documents
- Scientific advice and protocol assistance adopted during the CHMP meeting 24-27 June
- Drugs for the Treatment of Partial Onset Seizures: Extrapolation of Efficacy from Adults to Pediatric Patients 1 Month of Age and Older
- Guidance for Industry: Pyrogen and Endotoxins Testing: Questions and Answers
- Applications for new human medicines under evaluation: July 2024
📚 Other
- EMA confirms its recommendation to update the antigenic composition of authorised COVID-19 vaccines for 2024-2025
- European Union example instances – E2B(R3) testing files
- Call for Abstracts for Healthcare Systems Ergonomics and Patient Safety 2025
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