ComplianceOnline

Pediatric Clinical Trials in the EU: Regulatory, Scientific, and Ethical Challenges

Instructor: Laura Brown
Product ID: 701983
  • Duration: 60 Min

recorded version

$299.00
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Recorded Link and Ref. material will be available in My CO Section

Training CD

$499.00
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CD and Ref. material will be shipped within 15 business days

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Read Frequently Asked Questions

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 course is certified by Regulatory Affairs Professional Society (RAPS). Attendees of Live Webinar are eligible for 1 RAC Points up on full completion of the course."

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.

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?

Who Will Benefit:

This webinar will provide critical assistance to FDA and EMA regulated companies currently carrying out or preparing to conduct clinical trials for pharmaceutical, biotechnology, and biologics products in paediatrics.

  • Clinical Development managers and personnel
  • Clinical research associates
  • Clinical Research archiving and document management personnel
  • Quality assurance managers and auditors
  • Clinical Development managers and personnel
  • Consultants
  • Regulatory Affairs professionals
  • Academic clinical trial sites

Instructor Profile:

Dr. Laura Brown , PhD, MBA, Diploma Clinical Sciences is an independent QA and Training Consultant in the Pharmaceutical Industry, and Course Director for the MSc in Clinical Research, School of Pharmacy at the University of Cardiff. Laura has more than 17 years experience of running clinical trials and clinical quality assurance in the pharmaceutical industry. She has held a number of international and senior management QA positions in the pharmaceutical industry including as an Associate Director with a leading GCP audit consultancy. She has worked for several international companies including GlaxoWellcome, Hoechst Marion Roussel and Phoenix International.

Laura is author of a chapter on “Training QA staff” in the leading GXP book: “Good Clinical, Laboratory and Manufacturing Practices” (2007). She is author of SCRIP's latest GCP guide and a “Practical Guide to the Clinical Trial Directive. She is also co-author of several books including “Developing the Individual” and “Project Management for the Pharmaceutical Industry”. She has regularly lectured at conferences and on training courses on QA and GCP issues.

Laura runs many training courses both on public courses and in-company on topics including: pharmaceutical project management, understanding the pharmaceutical industry/drug development, writing and managing SOPs, GCP , the clinical trial directive, managing clinical trials, QA Management and business skills, how to prepare for audit and inspection.

Topic Background:

Serious medication errors due to the off-label and unlicensed use of medicines in the pediatric population have led the EMA and the FDA to develop the regulations for testing medicines in the pediatric population. The Pediatric Regulation in the EU mandate pharmaceutical companies test medicines on children. It is essential that children have safe, effective medicines but this needs to be balanced against the money companies will make. Pharmaceutical companies therefore need scrupulous ethical safeguards to ensure fully informed consent from parents and assent from the children. This will facilitate children's research needs and refute accusations of using children for profit.

Children are not small adults and have different needs and expectations when it comes to making sure their medicines are safe and effective. This has a huge impact concerning the ethics of using children in pharmaceutical studies as they have limited understanding and may not be able to make informed decisions. There is therefore a huge weight of ethical responsibility on the pharmaceutical researcher to take particular care when running such studies.

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