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Conference Directory
Pediatric Clinical Trials in the EU: Regulatory, Scientific, and Ethical Challenges
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Venue Name: Online Event
Country: United States of America
City: Palo Alto
State: california
Number of Attendees: Unknown
Webinar or Virtual Event: Yes
Keywords: Clinical research associates, Consultants, 21 CFR 54, Clinical Investigation, Financial Disclosure, 2011 draft guidance, financial disclosure regulations, clinical investigators, financial interests
Start Date of Conference:: 11-18-2011
End Date of Conference: 11-18-2011
Description of Conference: 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.
Why Should You Attend:
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.
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?
NOTE : Use this Promocode (128600) to avail 10% discount, valid upto 16th November 2011.
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Pediatric Clinical Trials in the EU: Regulatory, Scientific, and Ethical Challenges
