Monday Weekly Summary (12.02 – 18.02.2024)
? 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 (12.02 – 18.02.2024) 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
- An Overview of Regression Models for Adverse Events Analysis
- Promoting Collaboration of Regulators and Patients in Improving Drug Safety and Regulatory Decision Making
- The Unseen Hand: AI-Based Prescribing Decision Support Tools and the Evaluation of Drug Safety and Effectiveness
- Implementation of a Taxonomy-Based Framework for the Selection of Appropriate Drugs and Outcomes for Real-World Data Signal Detection Studies
? Recommendations/Regulations/Guidelines/Instructions/FAQs
- Biostatistics
- Non-inferiority and equivalence comparisons in clinical trials – Scientific guideline
- The ICH Q3C(R9) Guideline reaches Step 4 of the ICH Process
- Guidance on the electronic submission of information on investigational medicinal products for human use in the Extended EudraVigilance medicinal product dictionary (XEVMPD)
- Reflection paper on investigation of pharmacokinetics in the obese population – Scientific guideline
- Scientific recommendations on classification of advanced therapy medicinal products
- ICH E2D(R1) draft Guideline reaches Step 2 of the ICH process
? Reports
- Annual report on the use of the special contribution for orphan medicinal products – 2023
- European Medicines Agency mid-year report 2022 (January-June 2022)
- European Medicines Agency mid-year report 2021 (January-June 2021)
- Annual activity report 2022
- Applications for new human medicines under evaluation: February 2024
- CTIS newsflash – 9 February 2024
?Trainings/Presentations/Invitations
- ICH M10 “Bioanalytical Method Validation and Study Sample Analysis” Training Material is now available on the ICH Website
- Update webinar on Regulatory Procedure Management for PLM on IRIS
- Multi-stakeholder webinar on the HMA-EMA Catalogues of real-world data sources and studies, European Medicines Agency, Amsterdam, the Netherlands, Broadcast, from 4 March 2024, 10:00 (CET) to 4 March 2024, 12:00 (CET)
- Launch of new HMA-EMA catalogues of real-world data sources and studies
? News/Press Releases
?️ Meeting agendas/minutes/summary
- Agenda of the CAT meeting 14-16 February 2024
- 24 January 2024, Virtual (Belgium) – 115th HMA Meeting I Stakeholders informatio…
- Agenda of the COMP meeting 13-15 February 2024
- Joint HMA/EMA multi-stakeholder workshop on Patient Registries
?Product opinion/decisions/updates
? Other
- European Medicines Agency’s Data Protection Notice for the HMA-EMA Catalogue of real-world data sources (and networks and institutions)
- CHMP rules of procedure
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