Monday Weekly Summary (11.03 – 17.03.2024)
? 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 (11.03 – 17.03.2024) 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
- The Reporting Recommendations Intended for Pharmaceutical Risk Minimization Evaluation Studies: Standards for Reporting of Implementation Studies Extension (RIMES-SE)
- The Problems with Online Health Product Sales: How can Regulations be Improved?
- Drug–Drug Interactions and Actual Harm to Hospitalized Patients: A Multicentre Study Examining the Prevalence Pre- and Post-Electronic Medication System Implementation
- Promoting Innovation in Medical Product Assessment: A Risk-based Framework for Evaluating Computational Models for Regulatory Decision-Making
? Recommendations/Regulations/Guidelines/Instructions/FAQs
- Coordination of pharmacovigilance inspections: What is the day zero for ICSRs described in the medical literature?
- Commission proposes new measures for the better lifecycle management of medicine authorisations
- COMMISSION DELEGATED REGULATION (EU) …/… of 11.3.2024 amending Regulation (EC) No 1234/2008 as regards the examination of variations to the terms of marketing authorisations for medicinal products for human use
- Drug Quality, Current Good Manufacturing Practice Inspections and Compliance
- EudraVigilance registration documents
- EudraVigilance registration manual
- New Organization First User QPPV/RP or Change of EU QPPV/RP
- Member states contact points for translations review
- Proline – Scientific guideline
- E2D(R1) Post-Approval Safety Data: Definitions and Standards for Management and Reporting of Individual Case Safety Reports
- Annual Reportable Labeling Changes for New Drug Applications and Abbreviated New Drug Applications for Nonprescription Drug Products
- Product-specific bioequivalence guidance
- Opinions and letters of support on the qualification of novel methodologies for medicine development
- Procedural advice for orphan medicinal product designation: Guidance for sponsors
? Reports
- Applications for new human medicines under evaluation: March 2024
- Factsheet – Addressing shortages of medicines and ensuring security of supply
- Factsheet – Incentives to steer innovation and achieve public health objectives
- Factsheet – Access to medicines in all Member States
?Trainings/Presentations/Invitations
- PQRI Workshop: Challenges and Opportunities for Modified Release Oral Drug Product Development – 04/18/2024
- FDA/PQRI/EUFEPS Global Bioequivalence Harmonisation Initiative (GBHI): 6th International Workshop – 04/16/2024
- Q&A with FDA Podcast
- Multi-stakeholder workshop on data quality framework for Adverse Drug Reaction reporting
- Orphan Medicines Development – ask the European Regulator
- Pharmacodynamic Biomarkers: Their Role in Biosimilar Product Development
- EMA/EORTC workshop: How can PRO and HRQoL data inform regulatory decisions?
- CTIS Bitesize Talk: How to submit a transitional trial in CTIS, Online, Broadcast, from 29 February 2024, 16:30 (CET) to 29 February 2024, 18:00 (CET
- Good Clinical Practice & Pharmacovigilance Compliance Symposium Day Three – PM
- Good Clinical Practice & Pharmacovigilance Compliance Symposium Day Two – PM
- Good Clinical Practice & Pharmacovigilance Compliance Symposium Day One – PM
? News/Press Releases
- European Medicines Agency’s privacy statement for the operation of the Security Access Control System
- Supporting innovation
- DARWIN EU Advisory Board: Membership
- Factsheet – Steering innovation to address unmet medical needs
?️ Meeting agendas/minutes/summary
- Industry annual bilateral meetings
- PEC Meeting Summary – February 2024
- FDA Roundup: March 12, 2024
- Agenda of the COMP meeting 12-14 March 2024
- Minutes of the CHMP meeting 22-25 January 2024
?Product opinion/decisions/updates
- Using Patient-Reported Outcomes to Measure Frailty in Patients with Multiple Myeloma
- Ensuring the Rigor of Regulatory Science: CDER Conducts Laboratory and Clinical Studies to Investigate Reports of NDMA Production from Ingested Ranitidine Products
- Learning from Patient Text Messaging to Optimize Opioid Prescribing and Reduce Misuse
- Real-world Evidence from a Narrow Therapeutic Index Product (Levothyroxine) Reflects the Therapeutic Equivalence of Generic Drug Products
- Rigorous Detection of Nitrosamine Contaminants in Metformin Products: Balancing Product Safety and Product Accessibility
- Fludarabine supply shortage
? Other
#AIDIFY #RegulatoryUpdates #PharmaIndustry #StayInformed #ComplianceMatters