Post by Martin King
Regulatory Affairs & Quality Assurance Expert | QA/RA Business Enabler | Medical Device, In Vitro Diagnostics, Combination Product | Navigating FDA, IVDR, MDR, PRRC | ISO Lead Auditor | [email protected]
๐๐ง๐ต๐ฒ ๐ต๐ถ๐ด๐ต๐น๐ถ๐ด๐ต๐๐ ๐ผ๐ณ ๐ค๐/๐ฅ๐ ๐จ๐ฝ๐ฑ๐ฎ๐๐ฒ๐ ๐ญ๐ฐ. ๐๐๐น๐ ๐ฎ๐ฌ๐ฎ๐ฒ ๐ค๐๐ฎ๐น๐ถ๐๐ ๐๐๐๐๐ฟ๐ฎ๐ป๐ฐ๐ฒ & ๐ฅ๐ฒ๐ด๐๐น๐ฎ๐๐ผ๐ฟ๐ ๐๐ณ๐ณ๐ฎ๐ถ๐ฟ๐ Click on the ๐to access the content. try the Microsoft Copilot ๐ ๐๐บ ๐ข๐ฑ๐ฐ๐ญ๐ฐ๐จ๐ช๐ฆ๐ด, ๐ฅ๐ถ๐ฆ ๐ต๐ฐ ๐ช๐ฏ๐ต๐ฆ๐ณ๐ฏ๐ข๐ต๐ช๐ฐ๐ฏ๐ข๐ญ ๐ต๐ณ๐ข๐ท๐ฆ๐ญ ๐ ๐ธ๐ช๐ญ๐ญ ๐ฃ๐ฆ ๐ญ๐ข๐ต๐ฆ ๐ธ๐ช๐ต๐ฉ ๐ฑ๐ฐ๐ด๐ต๐ด ๐ต๐ฉ๐ณ๐ฐ๐ถ๐จ๐ฉ 23. ๐๐ถ๐ญ๐บ 2026. ๐ ย ๐พ๐ก๐๐๐ ๐ค๐ฃ ๐ฉ๐๐ ๐๐ง๐ฉ๐๐๐ก๐ ๐ฉ๐ค ๐ก๐๐๐ง๐ฃ ๐ข๐ค๐ง๐. ๐ฆ๐๐บ๐บ๐ฎ๐ฟ๐ ๐ณ๐ผ๐ฟ ๐ญ๐ฐ. ๐๐๐น๐ ๐ฎ๐ฌ๐ฎ๐ฒ ๐ค๐๐ฎ๐น๐ถ๐๐ ๐๐๐๐๐ฟ๐ฎ๐ป๐ฐ๐ฒ & ๐ฅ๐ฒ๐ด๐๐น๐ฎ๐๐ผ๐ฟ๐ ๐๐ณ๐ณ๐ฎ๐ถ๐ฟ๐ ๐ธDepartment of Health and Social Care: SaBTO: Advisory Committee on the Safety of Blood, Tissues and Organs (SaBTO) Annual Report 2024 to 2025 ๐ธEuropean Medicines Agency: Guidance for Applicants for the Preparation of the Precise Scope Section of the Variation Application Form ๐ธEuropean Union Agency for Cybersecurity (ENISA): Where do SMEs stand in preparing for the Cyber Resilience Act? ๐ธFDA: FDA Formal Meetings Between FDA and Sponsors or Requestors of Over-the-Counter Monograph Drugs ๐ธFDA: FDA Topical Dermatologic Corticosteroids: In Vivo Bioequivalence ๐ธFDA: FDA Psychedelic Drugs: Considerations for Clinical Investigations ๐ธWorld Health Organization: WHO and Global Regulators Advance Shared Roadmap for Greener Pharmaceuticals ๐ธBARBARA PIROLA: THE FIRST LAW OF PRIOR KNOWLEDGE If an Organization Cannot Reuse What It Already Knows. ๐ธBARBARA PIROLA: The Hidden Gap Between Knowledge Management and Quality Management. ๐ธBARBARA PIROLA: PRIOR KNOWLEDGE AI, Digitalization and Pharmaceutical Quality Knowledge Management (PQKM) ๐ธ@Christine Lee: The CAPA Quality Improvement Toolkit ๐ธConner Harman: Morning everyone, looking forward to Episode 10 of Regulatory Voices, where I am joined by Bhargavi Patel, Head of Regulatory Affairs at Galderma Immunology. ๐ธEunice Baker White: Bridging EU MDR and FDA QMSR: A Unified Approach to Post-Market Surveillance ๐ธFayeque Peerzade: The Good Practice Show: FDA's Elsa did not lie. ๐ธHadi Danawi, PhD, MPH ุฏ. ูุงุฏู ุถูุงูู: Happy Monday-July 13 & 14, 2026. You can follow MENASA Group on LinkedIn for the latest daily pharma/clinical trials news updates. ๐ธLeonard (Leo) Eisner: IEC 60601-1, edition 3.2 today is ~500 pages. ๐ธLeonard (Leo) Eisner: The IEC 60601-1, 4th edition timeline was just revised, and here is the updated ETA. ๐ธMario Gabrielli Cossellu: Fees of Notified Bodies EU MDR, IVDR ๐ธPaula Andrea Pirson: LATAM: Registro de Medicamentos ๐ธRabiea ๐ท๏ธ Assoc. Professor: If you're ready to stop wondering how to break into regulatory affairs and actually start your career, now's the time! ๐ธYan Kugel: The flipbook highlights key implementation considerations for Process Analytical Technology ๐ง๐ต๐ฎ๐ป๐ธ ๐๐ผ๐ ๐ for ๐๐ผ๐๐ฟ time and please ๐๐ถ๐ธ๐ฒ ๐, ๐ฆ๐ต๐ฎ๐ฟ๐ฒ, and/or ๐๐ผ๐บ๐บ๐ฒ๐ป๐ Compiled with the help of Microsoft Copilot and ChatGPT