Monday Weekly Summary (12.08 - 18.08.2024)

?? 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 (12.08 - 18.08.2024) 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 ?

• Caveats of Covariate Adjustment in Disproportionality Analysis for Best Practices
• Unveiling the Burden of Drug-Induced Impulsivity: A Network Analysis of the FDA Adverse Event Reporting System

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

• Guide to CTIS training material catalogue
• Questions and answers on the impact of mutual recognition agreement between the European Union and the United States as of 7 August 2024
• Scientific advice and protocol assistance adopted during the CHMP meeting 22-25 July 2024
• EudraVigilance: how to register (Related documents update)
• IRIS guide for applicants - How to create and submit scientific applications, for industry and individual applicants
• Biological and chemical threats
• Clinical Trial: appeal procedure – guideline from Polish HA
• Questions and answers relating to Grant Procedure no. EMA/GRANT/2024/02/IA - Medicines regulatory systems strengthening in Sub-Saharan Africa
• Submit a Standardized Data Sample to FDA
• eCTD Submission Standards for eCTD v4.0 and Regional M1
• FDA Announces Milestone in Sodium Reduction Efforts, Issues Draft Guidance with Lower Target Levels for Certain Foods

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?? Reports

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??Trainings/Presentations/Invitations

• Clinical Trials Information System (CTIS): online training modules
• What is Accelerated Approval?
• How are Cancer Drugs Approved?

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??? News/Press Releases

• WHO Director-General declares mpox outbreak a public health emergency of international concern

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??? Meeting agendas/minutes/summary

• HMPC meeting report on European Union herbal monographs, guidelines and other activities - 27-29 May 2024

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??Product opinion/decisions/updates

• Glatiramer acetate DHPC
• List of medicines currently in PRIME scheme
• List of signals discussed at PRAC since September 2012

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?? Other

• Electronic Regulatory Submissions and Review Helpful Links
• Data Standards in the Drug Lifecycle

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#AIDIFY #RegulatoryUpdates #PharmaIndustry #StayInformed #ComplianceMatters

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