Pharma Initiatives
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Wednesday, July 28, 2021 · 12:00 PM EDTICH E6(R2) has ushered in an era of risk-based quality management (RBQM). Yet, many sponsors struggle with the aspect of RBQM that drives the most value - Central Monitoring. Pharma Initiatives has developed a practical guide for successful Centra...
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Thursday, June 17, 2021 · 12:00 PM EDTException From Informed Consent (EFIC) studies have a distinct and challenging set of regulatory guidelines. While 21 CFR 50.24 provides the regulatory framework for EFIC studies in the US, implementing these regulations in practice is not straigh...