Pediatric Clinical Trials in the EU: Regulatory, Scientific, and Ethical Challenges (Clinical Compliance )
Venue: Online Event
|Event Date/Time: Sep 28, 2011||End Date/Time: Sep 28, 2011|
This webinar will provide critical assistance to FDA and EMA regulated companies currently carrying out or preparing to conduct clinical trials in pediatrics in the EU.
This presentation cover recommendations on various ethical aspects of the performance clinical trials for treating, preventing or diagnosing a disease or condition in pediatrics.
The speaker will explain how to ensure pediatric studies must be child and family-focused if they are to run safely, smoothly and to schedule by complying with the EU Clinical Trial Directive guideline which provides excellent guidance on how to run ethically sound clinical trials in children. A practical, step-by-step guide to running successful clinical trials in pediatrics will be provided to help ensure compliance.
Areas Covered in the Seminar:
- Learn how to plan and manage successful clinical trials in paedeiatrics
- Understand the latest regulatory guidelines and how it will impact your clinical trials in practice
- What are the considerations for consent and assent?
- What are the practical requirements for running paediatric clinical trials?
- Appreciate the demands of paediatric populations and how this will impact your trial
- What are the special requirements for ethical review?
- How to reduce fear and distress?
- What are the recommendations for bodyweight and volumes of blood that can be taken?
- How to avoid unnecessary duplication of trials?
- What about the standards for non-EU countries for running clinical trials?