Monday Weekly Summary (07 - 13.08.2023)

???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?(07 - 13.08)?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 (Open access)

• Leveraging MEDLINE indexing for pharmacovigilance – Inherent limitations and mitigation strategies
• Safety Monitoring of COVID-19 Vaccines: Perspective from the European Medicines Agency

???Recommendations/Regulations/Guidelines/FAQs

• Financial Disclosure by Clinical Investigators
• Updated Polish HA website: European procedures
• Updated Polish HA website: Guideline on veterinary good pharmacovigilance practices
• The Head of Polish HA Notice of August 7, 2023, regarding the provision of scientific advice
• Guidance to applicants / Marketing Authorisation Holders (MAHs) on oral explanations at EMA??

?? Reports

• N/A

??Free trainings/presentations

• 2023 08 10 MedDRA Coding Basics

???News/Press Releases

• EMA business hours over Assumption Day, 15 August
• Shortage of methotrexate

??? Meeting agendas/minutes/summary

• PRAC meetings in 2025 and 2026

?? Other

• List of eligible industry stakeholder organisations

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