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IMDRF/MC/N2FINAL:2025 (Edition 13) Standard Operating Procedures version 2
The International Medical Device Regulators Forum (IMDRF) has released its updated Standard Operating Procedures (IMDRF/MC/N2FINAL:2025, Edition 13 Version 2). This critical document lays out the framework for how international medical device regulatory convergence is...
New EU Regulation : Safer Cosmetics Ahead
On 13 May 2025, the European Commission adopted Regulation (EU) 2025/877, amending the Cosmetic Products Regulation., and strengthening the safety of cosmetics by banning certain CMR (carcinogenic, mutagenic, or toxic for reproduction) substances. The regulation is...
CIOMS proposes best practices for AI in pharmacovigilance
The Council for International Organizations of Medical Sciences (CIOMS) has issued a draft report detailing a set of best practices to guide the integration of artificial intelligence in pharmacovigilance (PV) activities. The report highlights that a crucial...
AI Literacy – Questions & Answers
The EU AI Office just published its AI Literacy - Questions & Answers.
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