Requirements for Running Clinical Trials in Pediatrics for the EU

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 Webinar:

• Learn how to plan and manage successful clinical trials in pediatrics
• 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

Laura Brown
Independent QA and Training Consultant, Laura Brown Training and Development

Dr Laura Brown is an independent Pharmaceutical QA, Management and Training Consultant, and Course Director for the MSc in Clinical Research, School of Pharmacy at the University of Cardiff. Laura has more than 20 years' experience of Quality Assurance and managing international clinical trials including risk identification and management and risk based monitoring. She has worked for several companies including GSK, Hoechst Marion Roussel, Good Clinical Research Practices and Phoenix International. She has consulted with numerous pharmaceutical companies, suppliers to the pharmaceutical industry as well as academic institutions.

Dr Brown has an MBA with specialization in project management including risk management. She is also the external project management expert for a pharmaceutical e-learning MSc module in project management covering risk management, and the author of two books on project management including the leading book “Pharmaceutical Project Management” (Gower).

Frequently Asked Questions:

1. How do I contact ClinicalTrials.gov if I have a question about my study record?
2. What are the potential benefits of participating in a clinical trial?
3. How about the safety of the participant in any clinical trial specially children’s?
4. Does a participant continue to work with a primary healthcare provider while in the trial?

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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