📢 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 (01.07 – 07.07.2024) 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
- Peer Review in Pharmacovigilance: Lens on Disproportionality Analysis
- Lessons Learned on Observed-to-Expected Analysis Using Spontaneous Reports During Mass Vaccination
📝 Recommendations/Regulations/Guidelines/Instructions/FAQs
- Pharmacovigilance fees payable to the European Medicines Agency
- New Fee Regulation working arrangements
- M14 General Principles on Plan, Design, and Analysis of Pharmacoepidemiological Studies That Utilize Real-World Data for Safety Assessment of Medicines
- Clinical Trial Information System (CTIS) – Sponsor handbook
- Approved Drugs: Questions and Answers
- European Medicines Agency’s data protection notice for the HMA-EMA Catalogue of real-world data sources (and networks and institutions)
- Concept paper on the need for revision of the guideline on clinical investigation of medicinal products for the treatment of psoriatic arthritis
- Clinical investigation of medicinal products for the treatment of psoriatic arthritis – Scientific guideline
- Products Management Services (PMS) – Implementation of International Organization for Standardization (ISO) standards for the identification of medicinal products (IDMP) in Europe – Chapter 7
- Concept paper on the revision of the COVID-19 vaccines guidance documents
- ICH reflection paper on pursuing opportunities for harmonisation in using real-world data to generate real-world evidence
- Outcome of public consultation on ICH Reflection paper on pursuing opportunities for harmonization in using real-world data to generate real-world evidence
📖 Reports
💡Trainings/Presentations/Invitations
- Industry Update webinar on Regulatory Procedure Management for Product Lifecycle Management on IRIS
- New Fee Regulation: webinar for veterinary Marketing Authorisation Holders
- CTIS Bitesize talks
- Risk Evaluation and Mitigation Strategies (REMS)
- FAERS
- Medication Guides: Distribution Requirements for Health Care Professionals
- FDA’s Role in Foreign Drug Manufacturing
- Drug Name Review
📰 News/Press Releases
- Recent additions to EMA’s management team
- WHO updates laboratory biosecurity guidance
- Organisation chart: Advisory functions
🗓️ Meeting agendas/minutes/summary
📋Product opinion/decisions/updates
- Appendix 1: Acceptable intakes established for N-nitrosamines
- List of European Union reference dates and frequency of submission of periodic safety update reports (PSURs)
📚 Other
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