REFERÊNCIAS:
.-EMA: Questions and answers: Good manufacturing practice – Data Integrity Section
.-FDA: FDA Data Integrity Guidance
.-MHRA: MHRA Data Integrity Definitions and Guidance
.-PIC/S: PIC/S Guidance
.-WHO: WHO Guidance
News & Trends
Procurar
Recentes
- Final version of its Guideline for Good Clinical Practice E6(R3). Adopted on 6 january 2025
- New EU rules for health technology assessments become effective
- ICH Q4B(R1) Guideline on evaluation and recommendation of pharmacopoeial texts for use in the ICH regions Step 5
- Inter-association joint position paper on Electronic Product Information
- MDCG 2023-3 rev.2 – Questions and Answers on vigilance terms and concepts as outlined in the Regulation (EU) 2017/745 under Regulation (EU) 2017/746 – January 2025
- Considerations for the Use of Artificial Intelligence To Support Regulatory Decision-Making for Drug and Biological Products
- Accelerated Approval and Considerations for Determining Whether a Confirmatory Trial is Underway
- Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations