📢 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 (27.05 – 02.06.2024) 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
- Causality assessment of adverse drug reaction: A narrative review to find the most exhaustive and easy-to-use tool in post-authorization settings
- Optimizing healthcare system by amalgamation of text processing and deep learning: a systematic review
📝 Recommendations/Regulations/Guidelines/Instructions/FAQs
- Information on the Member States requirement for the nomination of a pharmacovigilance (PhV) contact person at national level
- User guide for micro, small and medium-sized enterprises
- Creutzfeldt-Jakob disease and plasma-derived and urine-derived medicinal products – Scientific guideline
- Checklist for initial notifications for parallel distribution: guidance for industry
- Checklist for annual updates for parallel distribution: guidance for industry
- Frequently asked questions about parallel distribution
- IICH M14 guideline on general principles on plan, design and analysis of pharmacoepidemiological studies that utilize real-world data for safety assessment of medicines – Scientific guideline
📖 Reports
- Annual report highlights progress in science, medicines and health in 2023
- Annex 10 – 2023 annual report of the European Medicines Agency – CHMP opinions on initial evaluations and extensions of therapeutic indication
- Annexes – 2023 annual report of the European Medicines Agency
💡Trainings/Presentations/Invitations
- REdI Annual Conference 2024: CDER (Drugs) Innovation in Medical Product Development (Day 1 of 2)
REdI Annual Conference 2024: CDER (Drugs) Innovation in Medical Product Development (Day 2 of 2) - REdI Annual Conference 2024: CBER (Biologics) Innovation in Medical Product Development (Day 1 of 2)
- REdI Annual Conference 2024: CBER (Biologics) Innovation in Medical Product Development (Day 2 of 2)
- REdI Annual Conference 2024: CDRH (Devices) Innovation in Medical Product Development (Day 1 of 2)
- REdI Annual Conference 2024: CDRH (Devices) Innovation in Medical Product Development (Day 2 of 2)
- Product Management Service (PMS) Product UI training (access & navigation), Online, European Medicines Agency, Amsterdam, the Netherlands, from 3 June 2024, 10:00 (CEST) to 3 June 2024, 11:30 (CEST)
- Cancer Medicines Forum workshop – video of the Belgian Health minister
- Environmental Risk Assessment (ERA) Assessors Training, European Medicines Agency, Amsterdam, the Netherlands, Broadcast, from 23 May 2024, 13:00 (CEST) to 24 May 2024, 14:00 (CEST)
📰 News/Press Releases
- N/A
🗓️ Meeting agendas/minutes/summary
- Agenda of the CHMP meeting 27-30 May 2024
- Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 27-30 May 2024
- Agenda – PDCO agenda of the 28-31 May 2024 meeting
- Added in May 2024 27 May NEW – 28-29 May CMDh agenda 2 May NEW – Report from the…
📋Product opinion/decisions/updates
- List of medicinal products under additional monitoring
- Medicinal Products Committee – Update on the Polish HA website
- Extension of the validity of marketing authorizations for biocidal products until December 31, 2030 – Update on the Polish HA website
📚 Other
- LIVE from #WHA77: Artificial intelligence for health: opportunities, risks, and governance
- Patients’ and Consumers’ Working Party
- WHO Member States agree way forward to conclude Pandemic Agreement
- DARWIN EU Advisory Board: Membership
- Careers at EMA user-guide
#AIDIFY #RegulatoryUpdates #PharmaIndustry #StayInformed #ComplianceMatters