Module 5 Presentations

05/07/2024

Recommended references (3)

• Classification and analysis of the GCP inspection findings of GCP inspections conducted at the request of the CHMP (Inspection reports to EMA 2000-2012) http://www.ema.europa.eu/docs/en_GB/document_library/Other/2014/12 /WC500178525.pdf • Brennan Z. EMA re-confirms drug suspension due to faulty trial data from GVK Biosciencis. http://www.outsourcing-pharma.com/Clinical Development/EMA-re-confirms-drug-suspensions-due-to-faulty-trial-data from-GVK-Biosciences • http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/ referrals/Semler/human_referral_000403.jsp&mid=WC0b01ac05805c516f • Ross DB. The FDA and the Case of Ketek. http://www.nejm.org/doi/full/10.1056/NEJMp078032 • Gupta A:Fraud and misconduct in clinical research: A concern. Perspect Clin Res. 2013 Apr-Jun; 4(2): 144–147. doi: 10.4103/2229-3485.111800 (http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3700330 • https://www.ema.europa.eu/en/news/synchron-research-service suspension-medicines-over-flawed-studies

The Organisation for Professionals in Regulatory Affairs

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List of abbreviations

CAPA Corrective and Preventive Measure CRO Contract research organization CHMP CTD Clinical Trial Directive CTR Clinical Trial Regulation EC European Commission EMA European Medicines Agency GCP Good Clinical Practice ICH International Council for Harmonisation SOP Standard operating procedure QA Quality Assurance QC Quality Control

Committee for Medicinal Products for Human Use

QMS Quality management system TQA Technical quality agreements

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