Training Overview
This 2 half-days course presents a blend of Orphan Drugs regulatory guidance and approaches to clinical trials and assessment of evidence. The course covers the legal basis for approvals, how to design studies and a look at some recent methodological ideas that have been proposed. Evidence-Based Medicine and clear reporting of studies will be thoroughly discussed.
Key Takeaways:
• EMA and FDA expectations for Orphan Drugs clinical studies
• The Importance of avoiding Bias and Regression to the Mean
• Working with Evidence Based Medicine and Clinical trials
• How to design a study and which methodology to use
• Practical implementation of regulatory pathways
• Where do we (and don’t we) need randomised trials?
Who should attend?
- Drug Product Development scientists
- Regulatory Managers and specialists
- Clinical Development staff
- Statisticians
- Pharmacovigilance scientists
- Clinical research associates
- Clinical trial operations staff
Trainer
