📢 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 (10.06 – 16.06.2024) 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
📝 Recommendations/Regulations/Guidelines/Instructions/FAQs
- IRIS guide for applicants – How to create and submit scientific applications, for industry and individual applicants
- Variations guidelines: Proposed amendments to the European Commission guidelines on variations categories and procedures
- Executive summary for proposed amendments to the European Commission guidelines on variations categories and procedures
- European Commission guidelines on variations categories and procedures: Proposal for stakeholder consultation – track changes
- European Commission guidelines on variations categories and procedures: Proposal for stakeholder consultation – clean version
- Minimum inhibitory concentration (MIC) breakpoints
- Information on the Member States requirement for the nomination of a pharmacovigilance (PhV) contact person at national level
- Questions and Answers on the tailored scientific advice to support step-by-step development of new biosimilars
📖 Reports
💡Trainings/Presentations/Invitations
- Strategies to Increase Clinical Trial Participation for Diverse Communities: OMHHE REACH Consortium
- Product Management Service (PMS) Product UI training (access & navigation)
- Webinar Pilot to provide Scientific Advice to manufactures on certain high risk Medical Devices
- Public System Demo Q2/2024
📰 News/Press Releases
- Network Portfolio Roadmap
- Press Release: ICH Assembly Meeting, Fukuoka, Japan, June 2024
- Two new advice pilots to improve clinical trials in Europe
- Change management activities delivery plan
🗓️ Meeting agendas/minutes/summary
- Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 10-13 June 2024
- Agenda of the 124th meeting of the Management Board : 12-13 June 2024
- EMA Management Board: highlights of June 2024 meeting
- Agenda – Joint HMA/EMA Big Data Steering Group workshop on real-world evidence (RWE) methods
- Agenda – Biannual Big Data Steering Group and industry stakeholders meeting 2024
- Minutes of the CAT meeting 17-19 January 2024
- Minutes of the PRAC meeting 8-11 April 2024
- Minutes of the CHMP meeting 18-21 March 2024
- CHMP PROM minutes for the meeting on 11 March 2024
- Meeting Summary – Medicine Shortages Single Point of Contact (SPOC) Working Party – 15-16 April 2024
- Minutes of the HMPC meeting 18-20 March 2024
- Agenda of the PRAC meeting 10-13 June 2024
- Final Minutes – HMA-EMA joint Big Data Steering Group teleconference – 22 April 2024
📋Product opinion/decisions/updates
- Referral: Metamizole-containing medicinal products, metamizole Article 107i procedures Procedure started
- Article 57 product data
- PRAC recommendations on signals adopted at the 13-16 May 2024 PRAC meeting
- New product information wording – Extracts from PRAC recommendations on signals adopted at the 13-16 May 2024 PRAC
- List of signals discussed at PRAC since September 2012
📚 Other
- WHO releases report on state of development of antibacterials
- HMPC: overview of assessment work – priority list
#AIDIFY #RegulatoryUpdates #PharmaIndustry #StayInformed #ComplianceMatters