Masterclass Certificate in EU Clinical Trial Regulations
-- ViewingNowThe Masterclass Certificate in EU Clinical Trial Regulations is a comprehensive course designed to provide learners with in-depth knowledge of EU clinical trial regulations. This course is essential for professionals involved in clinical trials, drug development, and regulatory affairs, as it covers the latest regulations, guidelines, and best practices in EU clinical trials.
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โข Unit 1: Introduction to EU Clinical Trial Regulations
โข Unit 2: Overview of EU Clinical Trial Directive 2001/20/EC
โข Unit 3: Clinical Trials Regulation (EU) No 536/2014: Key Provisions
โข Unit 4: Clinical Trial Application (CTA) Process in the EU
โข Unit 5: Data Transparency and Publication in EU Clinical Trials
โข Unit 6: Safety Reporting and Pharmacovigilance in EU Clinical Trials
โข Unit 7: Ethical Considerations in EU Clinical Trials
โข Unit 8: Quality Management and Inspections in EU Clinical Trials
โข Unit 9: Pediatric Clinical Trials in the EU
โข Unit 10: Brexit and its Impact on EU Clinical Trials Regulations
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