📢 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 (03.06 – 09.06.2024) 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
- Key Opinion Leaders’ Interviews to Inform the Future of Benefit–Risk Planning in the Medical Total Product Life Cycle of Global Pharmaceutical and Medical Device Organizations
- Capone G, Eriksson B, Al M, van Belkum S, Broich K, Lamas M, Lunzer M, Nolan L, Ester C, Garcia Burgos J, Pioppo L, Zanoletty A, Arlett P. Accelerating clinical trials in the EU (ACT EU): transforming the EU clinical trials landscape. Nature Reviews Drug Discovery (Nat Rev Drug Discov) ISSN 1474-1784 (online) ISSN 1474-1776 (print). doi: 10.1038/d41573-024-00085-5
📝 Recommendations/Regulations/Guidelines/Instructions/FAQs
- Recommendations on medication errors
- Paediatric medicines: Overview
- Paediatric medicines: Research and development
- Paediatric medicines: applications and procedures
- Class waivers
- Paediatric investigation plan (PIP) – Key elements guidance
- Paediatric investigation plans: questions and answers
- Paediatric investigation plans: Templates and forms
- Template for scientific document
- Procedural advice on paediatric applications
- Guidance for applicants on Simultaneous National Scientific Advice (SNSA) – phase 2 pilot – Optimized process
- Removing an orphan designation
- IRIS guide for applicants – How to create and submit scientific applications, for industry and individual applicants
- Added in June 2024 5 June NEW – 23-25 April 2024 CMDh minutes NEW – Report from …
- Application form for European Medicines Agency certificates of medicinal products
📖 Reports
💡Trainings/Presentations/Invitations
- 2024 06 04 European Industry MedDRA User Group Webinar
- 2024 06 06 What is MedDRA and How is it Used?
- Pharmacovigilance: Overview
- Joint EMA EORTC follow up workshop on soft tissue and bone sarcoma workshop
- 185th Meeting of Vaccines and Related Biological Products Advisory Committee
- Virtual live hands-on training course for clinical trials sponsors using EudraVigilance system, Online, from 7 October 2024 to 9 October 2024
- Mandatory use of ISO/ICH E2B(R3) individual case safety reporting in the EU: hands-on training course using the EudraVigilance system, Online, from 16 September 2024 to 20 September 2024
📰 News/Press Releases
- CTIS newsflash – 31 May 2024
- Research projects conducted under the remit of the PRAC impact strategy
- Workplan 2023-2025: HMA-EMA joint Big Data Steering Group
🗓️ Meeting agendas/minutes/summary
- Joint HMA/EMA Big Data Steering Group workshop on real-world evidence (RWE) methods, Online, European Medicines Agency, Amsterdam, the Netherlands, Broadcast, from 14 June 2024, 09:00 (CEST) to 14 June 2024, 16:30 (CEST)
- Agenda – Joint HMA/EMA Big Data Steering Group workshop on real-world evidence (RWE) methods
📋Product opinion/decisions/updates
- Medicinal products containing oral retinoids (acitretin, alitretinoin, and isotretinoin): Pregnancy Prevention Program – reminder of risk minimization measures – published on PL HA website
- List of European Union reference dates and frequency of submission of periodic safety update reports (PSURs)
- List of medicines currently in PRIME scheme
- Referral: Kexxtone 32.4 g continuous-release intraruminal device for cattle, monensin Article 130(4) European Commission final decision, 23/04/2024, 15/05/2024
- Shortage of human normal immunoglobulins
📚 Other
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