Monday Weekly Summary (05.02 – 11.02.2024)
? 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 (05.02 – 11.02.2024) 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
? Recommendations/Regulations/Guidelines/Instructions/FAQs
? Reports
?Trainings/Presentations/Invitations
- 2024 02 07 Advanced MedDRA Coding
- European Medicines Agency (EMA) Patients’ and Consumers’ (PCWP) and Healthcare Professionals’ (HCPWP) Working Parties joint meeting, European Medicines Agency, Amsterdam, the Netherlands, from 27 February 2024 to 28 February 2024
? News/Press Releases
- Decision of the Executive Director on fee incentives for scientific advice, marketing authorisation applications and pre-authorisation inspections in the ATMP support pilot for academia
- Questions and answers on EMA pilot offering enhanced support to academic and non- profit developers of Advanced Therapy Medicinal Products (ATMPs)
?️ Meeting agendas/minutes/summary
- Meeting summary of the Medicine Shortages (SPOC) Working Party 14 December 2023
- Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 5-8 February 2024
- Joint HMA/EMA multi-stakeholder workshop on Patient Registries
- Eleventh meeting of the industry stakeholder platform on the operation of the centralised procedure for human medicines, European Medicines Agency, Amsterdam, the Netherlands, 24 November 2023
?Product opinion/decisions/updates
- Hydroxyprogesterone-containing medicinal products – referral HMPC: overview of assessment work – priority list
- Minimum inhibitory concentration (MIC) breakpoints
- Pseudoephedrine DHPC
- Pseudoephedrine – Risk of reversible posterior leukoencephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS)
- Human medicines highlights – February 2024
- Saxenda (liraglutide) supply shortage
- List of European Union reference dates and frequency of submission of periodic safety update reports (PSURs)
- PRAC recommendations on signals adopted at the 8-11 January 2024 PRAC meeting
- List of signals discussed at PRAC since September 2012
- New product information wording – Extracts from PRAC recommendations on signals adopted at the 8-11 January 2024 PRAC
- List of medicines currently in PRIME scheme
? Other
- Written question – Increase in cancer cases among the younger sections of the European population – E-000350/2024
- CTTI to Launch New Embedding Trials Feasibility Assessment Tool
- CDER’s OGD and EMA’s Parallel Scientific Advice Pilot Program for Complex Generics Works to Increase Harmonization and Bring Generic Drugs to Patients
- This page lists the current members and alternates of the Co-ordination Group fo…
- Roche on RBQM and AI in Clinical Trials: Secrets to Success
- Written question – EU supply chain directive – E-000281/2024
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