Pediatric Clinical Trials in the EU: Regulatory, Scientific, and Ethical Challenges 2011
conferencias > Education, Training conferencias > Pediatric Clinical Trials in the EU: Regulatory, Scientific, and Ethical Challenges
28 September, 2011
Palm Beach FL , Estados Unidos
This training will cover compliance requirements for running clinical trials in pediatrics, particularly in the EU to comply with the EU ethical considerations guidance for running clinical trials in pediatrics.
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.
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?
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.
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?
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