Mitigate risk and improve regulatory compliance with insider advice from FDA officials and industry experts. This online, interactive program features FDA officials and industry experts addressing CDER BIMO compliance and enforcement, FDA inspections, ClinicalTrials.gov requirements, and more.
Reduce your anxiety by being prepared for clinical trial inspections. This eLearning course takes you through the full cycle of a regulatory authority GCP inspection and answers key questions including: Why, when and where are regulatory inspections performed? Who can be inspected? And more.
Efficiently identify and report safety events in your clinical trials. This eLearning course, appropriate for all clinical research professionals, guides you through the complete event reporting cycle and critical timelines, as defined in ICH E2a and E6 Guidelines.
Expand your knowledge and skills in study protocol design and review. This e-Learning course covers the anatomy of a protocol, hypothesis development, study design, subject safety and data integrity risk considerations, protocol feasibility and protocol amendments.
Assess your and your team’s training needs quickly by conducting an ICH gap analysis. This eLearning course uses a game to challenge the learner’s knowledge and application of these important efficacy guidelines.