Monday Weekly Summary (21 - 27.08.2023)

?? 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 (21 - 27.08) 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)

• Mapping Strategies to Assess and Increase the Validity of Published Disproportionality Signals: A Meta-Research Study

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

• List of European Union reference dates and frequency of submission of periodic safety update reports (PSURs)
• Formal Dispute Resolution: Scientific and Technical Issues Related to Pharmaceutical CGMP
• Regulatory and procedural guideline: List of centrally authorised products requiring a notification of a change for update of annexes (updated)
• EVVET - EVWEB user manual (updated)
• EVVet3 EVWeb Production – Release notes (updated)
• Q&A: Good clinical practice (GCP) (updated)

?? Reports

• Communication Perception Survey 2022

??Trainings/presentations

• 2023 08 23 What's New with MedDRA V26.1 and the MSSO
• 2023 08 24 Advanced MedDRA Coding

??? News/Press Releases

• New WHO Civil Society Commission to strengthen civil society organizations’ role in accelerating progress in global health
• WHO launches a new Global Initiative on Digital Health supported by the G20 Presidency
• Global partners commit to advance evidence-based traditional, complementary and integrative medicine
• Governments hold fourth round of discussions on proposed amendments to International Health Regulations (2005)
• 10 years of the Healthcare Professionals' Working Party

??? Meeting agendas/minutes/summary

• Meeting Summary - Medicine Shortages (SPOC) Working Party, 16 June 2023

Product opinion/decisions/updates

• Periodic safety update single assessment: Yellow fever vaccine (live) : List of nationally authorised medicinal products - PSUSA/00003135/202212
• Other products updates

?? Other

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