📢 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 (17.06 – 23.06.2024) 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.
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🌟 Scientific Articles
- Identification of Pregnancy Adverse Drug Reactions in Pharmacovigilance Reporting Systems: A Novel Algorithm Developed in EudraVigilance
- A Pilot, Predictive Surveillance Model in Pharmacovigilance Using Machine Learning Approaches
- Unveiling the future: precision pharmacovigilance in the era of personalized medicine
- Educational interventions in pharmacovigilance to improve the knowledge, attitude and the report of adverse drug reactions in healthcare professionals: Systematic Review and Meta-analysis
- Pharmacovigilance in Pregnancy Studies, Exposures and Outcomes Ascertainment, and Findings from Low- and Middle-Income Countries: A Scoping Review
📝 Recommendations/Regulations/Guidelines/Instructions/FAQs
- The amendments of the Variation Regulation are published in the Official Journal of the European Union
- FAQs: How to create, submit and withdraw a Clinical Trial Application – CTIS Training Programme – Module 10
- Roles and permissions matrix summary – Authority workspace – CTIS Training Programme – Module 07
- Step-by-step guide : Create, submit and withdraw a clinical trial application and nonsubstantial modifications – CTIS Training Programme – Module 10
- Step-by-step guide: How to respond to requests for information received during the evaluation of a Clinical Trial Application – CTIS Training Programme – Module 11
- Checklist of required fields per application type – CTIS Training Programme – Module 10
- Clinical Trials Information System (CTIS) common features – CTIS Training Programme – Module 02
- Medicine shortages and availability issues: guidance for companies
- Medicine shortage mitigation plan – template
- Medicine shortage prevention plan – template
- European Medicines Agency post-authorisation procedural advice for users of the centralised procedure
- European Medicines Agency post-authorisation procedural advice for users of the centralised procedure: document with track changes
- Changing the labelling and package leaflet (Article 61(3) notifications)
- QRD guidance on the use of approved pictograms on the packaging of veterinary medicinal products authorised via the centralised, mutual recognition and decentralised procedures – Species pictograms
- GLP compliance: Non-clinical studies GLP compliance (annex to the cover letter)
- Rules for the implementation of Council Regulation (EC) No 29795 on fees payable to the European Medicines Agency and other measures – Revised implementing rules to the Fee Regulation as of 1 May 2024
- FDA updates guidance on interchangeability
- Considerations in Demonstrating Interchangeability With a Reference Product: Update
- Guide to information on human medicines evaluated by European Medicines Agency: what the Agency publishes and when
- Patient registries
- Appendix, on disclosure rules, to the functional specifications for the EU portal and EU database to be audited
📖 Reports
- N/A
💡Trainings/Presentations/Invitations
- 2024 06 18 MedDRA Coding of Medication Errors – General Principles
- Overview of guidelines
- Presentation – GMP Inspections MAA submission preparedness (A. Spinei, EMA)
- Public Workshop: Best Practices for Meeting Management Under PDUFA VII – 07/22/2024
- Product Management Service (PMS) Application Programming Interface (API) training session, Online, European Medicines Agency, Amsterdam, the Netherlands, from 8 July 2024, 14:00 (CEST) to 8 July 2024, 15:30 (CEST)
- Things to Know About Biosimilars and Interchangeable Biosimilars
- S3 Efficacy endpoints in oncology
- S1 Overview of EMA-approved anti-cancer products
- EMA HMA Pilot Educational Program Oncology G4
- G1 Introduction: Overview of the regulation of medicines in Europe
- G2 How does scientific advice work?
- G3 How do centralised procedures work
- G4 Propaedeutic for benefit-risk assessment
- G5 Input CTD application, Output regulators’ assessment report
- G6 Case studies
📰 News/Press Releases
- CTIS newsflash – 14 June 2024
- Clinical Trials Information System
- Development of the Clinical Trials Information System
🗓️ Meeting agendas/minutes/summary
- Dates of 2025 Scientific Advice Working Party (SAWP) meetings and submission deadlines scientific advice, protocol assistance, qualification of biomarkers and EMA/EUnetHTA parallel consultation requests
- Agenda of the PRAC meeting 4-7 March 2024
- Workplan 2023-2025: HMA-EMA joint Big Data Steering Group
- Minutes of the 123rd meeting of the Management Board on 21 March 2024
- PDCO minutes of the 23-26 April 2024 meeting
- Agenda of the COMP meeting 18-20 June 2024
📋Product opinion/decisions/updates
📚 Other
- WHO issues warning on falsified medicines used for diabetes treatment and weight loss
- Recent Publication Reviews How CTTI’s Digital Health Trial Hub Can Unlock the Potential of Digitalizing Trials
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