Monday Weekly Summary (06.05 - 12.05.2024)

?? 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 (06.05 - 12.05.2024) 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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??Join FREE webinar focusing on the application of ChatGPT in the pharma industry

We invite you to a FREE event co-organized by AIDIFY and?Miquido. During interactive workshops, you will learn how to effectively formulate prompts and gain practical skills that will significantly increase your productivity and professional efficiency.

?? Secure your spot now as we have?limited free seats available!

?? LEARN MORE & REGISTER NOW:?https://tiny.pl/d9c4v

??Title:?ChatGPT in the pharmaceutical industry

?? Speakers:?Julia Matuszewska,?Jerzy Biernacki,?Bartlomiej Ochyra

?? Date & Time:?16.05.2024, 4:30 – 7:00 P.M. CEST

?? Location:?MS Teams

?? Language:?Polish

?? Certificate:?Yes - minimum 80% correct answers in the test

?? Win a Prize:?Free Access to AIDIFY for 30 Days!

?? Limited free spaces available! Please remember to register via Event Page!

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??? Scientific Articles ?

• The Reporting of a Disproportionality Analysis for Drug Safety Signal Detection Using Individual Case Safety Reports in PharmacoVigilance (READUS-PV): Development and Statement
• The REporting of A Disproportionality Analysis for DrUg Safety Signal Detection Using Individual Case Safety Reports in PharmacoVigilance (READUS-PV): Explanation and Elaboration
• Comparators in Pharmacovigilance: A Quasi-Quantification Bias Analysis
• A Framework for Promoting Safety Monitoring of Herbal Medicines: The International Society of Pharmacovigilance Special Interest Group on Herbal and Traditional Medicines
• Can We Ask ChatGPT About Drug Safety? Appropriateness of ChatGPT Responses to Questions About Drug Use and Adverse Reactions Received by Pharmacovigilance Centers

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??? Recommendations/Regulations/Guidelines/Instructions/FAQs

• Clinical Trial Information System (CTIS) structured data form - Initial application, additional Member State Concerned, substantial modification, non-substantial modification

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?? Reports

• WHO Results Report 2023 shows notable health achievements and calls for concerted drive toward Sustainable Development Goals

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??Trainings/Presentations/Invitations

• 2024 05 09 MedDRA Coding Basics
• 2024 05 02 Data Analysis and Query Building with MedDRA
• Modeling and Simulation to Select Oncology Dosages - Session 1
• Modeling and Simulation to Select Oncology Dosages - Session 2
• Modeling and Simulation to Select Oncology Dosages - Session 3
• OTC Monograph Drug User Fee Program (OMUFA): Understanding FY 2024 User Fees and Registration - 06/18/2024
• One Health in Action: How EU Agencies are Tackling Environmental and Public Health Together
• CDER Learn
• Product Management Service Info-Day

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??? News/Press Releases

• New publication: Clinical trials. Practice, law, ethics
• Governments agree to continue their steady progress on proposed pandemic agreement ahead of the World Health Assembly
• Organisation chart: Advisory functions
• One Health: a joint framework for action published by five EU agencies

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??? Meeting agendas/minutes/summary

• Minutes of the COMP meeting 12-14 March 2024
• Meeting report - Joint EMA/EORTC Workshop on Soft Tissue and Bone Sarcoma Workshop

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??Product opinion/decisions/updates

• List of signals discussed at PRAC since September 2012
• PRAC recommendations on signals adopted at the 8-11 April 2024 PRAC meeting
• List of medicines currently in PRIME scheme
• Export Requirements for Human Drugs

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?? Other

• Record of data processing activity relating to Security Access Control System (public)
• European Medicines Agency’s privacy statement for the operation of the Security Access Control System
• European Medicines Agency’s data protection notice for the audiovisual tool for checking presence in meeting rooms
• Working Group XIV – Artificial Intelligence in Pharmacovigilance

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#AIDIFY #RegulatoryUpdates #PharmaIndustry #StayInformed #ComplianceMatters

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