Designing a Pediatric Clinical Trial - ethical consideration and how to manage per regulatory requirements

Instructor: Carol Owen
Product ID: 701510
  • Duration: 60 Min

recorded version

1x Person - Unlimited viewing for 6 Months
(For multiple locations contact Customer Care)
Recorded Link and Ref. material will be available in My CO Section

Training CD

One CD is for usage in one location only.
(For multiple locations contact Customer Care)
CD and Ref. material will be shipped within 15 business days

Customer Care

Fax: +1-650-963-2556


Read Frequently Asked Questions

This Pediatric Clinical Trial Design training explains the regulatory requirements for conducting clinical research in the pediatric population, the ethical considerations around the development of pediatric trials, and the challenges of research in this vulnerable population.

Why Should You Attend:
Kids are not small adults and there are different considerations when planning clinical trials in children. New demands from the US and EU regulatory agencies have increased the needs for well planned clinical trials in pediatric subjects. Ethical issues for the clinical researcher, parents, subjects and IRBs still remain. Pediatric trials involve challenges from recruiting, consenting/assenting, inclusion/exclusion criteria, and subject compliance and retention. Until recent regulatory changes, trials in pediatric subjects were often overlooked. Concerns about the safe use of available drugs in the children have raised the need for research in this vulnerable population.

Attend this training to know the regulatory requirements and how to incorporate it in conducting clinical research in the pediatric population, the ethical considerations, the challenges of research and difference between US and EU pediatric drug requirements.

Areas Covered in the seminar:

  • What are the recent regulations and how will they be implemented.
  • How do you incorporate the regulations into your clinical trial plans.
  • What are the critical elements of strategy for a global pediatric program.
  • Challenges in pediatric studies.
  • Changing landscape for pediatric clinical research.
  • Ethical issues for the researcher, parent, subject and IRB.
  • Recognize differences between US and EU pediatric drug requirements.

Who will benefit:

This course will benefit those:
  • Involved in the monitoring and/or quality assurance activities of clinical trials
    • And Who work for
      • Pharmaceutical industry
      • Medical Device companies
      • Contract Research Organizations (CRO)
      • Institutional Review Boards (IRBs) and Clinical trial sites involved in the oversight of clinical trial practices and quality

Instructor Profile:
Carol Owen, has been in the Clinical Research Industry for over 20 years. She recently held the position of Director of Quality Assurance for a large Contract Research Organization. She has been involved in training throughout her career particularly in the areas of GCP compliance, FDA regulations and requirements, and audit training. She has specialized in the pharmaceutical clinical trial business having previously worked for an international pharmaceutical company and two international CROs. She has expertise in a vast array of therapeutic areas and in Phase 1-4 clinical trials.

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