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The FDA’s updated compliance program manual
The FDA's updated compliance program manual page: https://www.fda.gov/medical-devices/quality-and-compliance-medical-devices/center-devices-and-radiological-health-cdrh-compliance-programs
The FDA’s Quality Management System Regulation (QMSR) is now LIVE and fully effective
Feb 02, 2026 marks the end of the 2‑year transition and the beginning of a globally aligned quality era, harmonized with ISO 13485:2016 👉 As of TODAY, all FDA-regulated companies must comply. If you manufacture, design, or distribute FDA-regulated medical...
ICH M11 guideline, clinical study protocol template and technical specifications – Scientific guideline
EMA Releases ICH M11: A New Era for Clinical Study Protocols The EMA has published the ICH M11 guideline, introducing a harmonised, structured and digital-ready template for clinical study protocols — a major step forward for global clinical research. 🔹...
Guidelines on key considerations in issuing recommendations on the classification of active substances as regards their supply (prescription and non-prescription status)
These guidelines provide an overview of the key considerations of the Committee of Experts on the Classification of Medicines as Regards their Supply (CD-P-PH/PHO), co-ordinated by the European Directorate for the Quality of Medicines & HealthCare (EDQM), Council...
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