Monday Weekly Summary (08.01 – 14.01.2024)
? 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 (08.01 – 14.01.2024) 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
- Artificial intelligence / machine-learning tool for post-market surveillance of in vitro diagnostic assays
- Evaluating Use of Artificial Intelligence for Drug Exposure and Effect Prediction
- Pharmacovigilance in High-Income Countries: Current Developments and a Review of Literature
- Industry Review of Best Practices for Risk Management of Drug-Induced Liver Injury from Development to Real-World Use
? Recommendations/Regulations/Guidelines/Instructions/FAQs
- Guidance on paediatric submissions
- Q&A: Good clinical practice (GCP)
- IRIS guide to registration and RPIs
- CTTI and FDA Share Strategies for Improving Timely, Accurate, and Complete Registration and Reporting of Summary Results Information for Applicable Clinical Trials on ClinicalTrials.gov
? Reports
- Human medicines highlights – January 2024
- Annual report of the Pharmacovigilance Inspectors Working Group for 2021-2022
?Trainings/Presentations/Invitations
- 2024 01 11 What is MedDRA and How is it Used?
- Advancing Transparency and Regulatory Science Activities on Risk Evaluation and Mitigation Strategy
- Quarterly System Demo Q4-2023
- 4th HMA/EMA Big Data Stakeholder Forum
- Explore the ISoP 22nd Annual Meeting “Putting Patients First in Pharmacovigilance : International Perspective From Global South” in Bali: Unveiling Exclusive Presentations for Our Esteemed Members!
- Clinical Trials Information System (CTIS) bitesize talk: Training materials, CTIS pre-requisites, and updates on transparency rules, Online, European Medicines Agency, Amsterdam, the Netherlands, 29 November 2023
? News/Press Releases
- FDA Approves Many New Drugs in 2023 that Will Benefit Patients and Consumers
- Big data
- Workplan 2023-2025: HMA-EMA joint Big Data Steering Group
- Work plan for the Pharmacovigilance Inspectors Working Group (PhV IWG) for 2024-2026
- EMA Funding
?️ Meeting agendas/minutes/summary
- Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 8-11 January 2024
- Pharmacovigilance Risk Assessment Committee (PRAC): 23-26 October 2023, European Medicines Agency, Amsterdam, the Netherlands, 23 October 2023
?Product opinion/decisions/updates
- Hydroxyprogesterone-containing medicinal products – referral
- Potential risk of neurodevelopmental disorders in children born to men treated with valproate medicines: PRAC recommends precautionary measures
- Scientific guidelines with summary-of-product-characteristics recommendations
- List of substances and products subject to worksharing for signal management
? Other
- Annex to interim measures regarding notification of pharmacovigilance alerts by marketing authorisation holders under Regulation (EU) 2019/6: contact points
- Policy on the determination of the condition(s) for a paediatric investigation plan (PIP) / waiver (scope of the PIP / waiver)
- Opinions and letters of support on the qualification of novel methodologies for medicine development
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