Overview: Drug companies face many challenges in pediatric clinical research. Pediatric trials come with a high level of complexity and cost.
In order for professionals to carry out a successful pediatric drug development plan, they need the right infrastructure and information to avoid obstacles such as slow recruitment, noncompliance and difficulties in developing the right study criteria and protocol. When conducting research on children, drug companies must ensure that ethical boundaries are observed in both the design and execution of pediatric trials. Attend this Webinar to understand the ethical, economic, regulatory and technical considerations when conducting clinical studies on children. Discussions evaluate the current issues in pediatric drug development and discuss approaches and best practices for overcoming these challenges.
Areas Covered in the Session: - Compilation of various regulatory and guidance documents from the FDA and OHRP on the conduct of research involving children
- Recent guidances on compliance and general considerations in the conduct of research on children
- General Considerations for the Clinical Evaluation of Drugs in Infants and Children
- Discuss Clinical Investigation of Medicinal Products in the Pediatric Population
- Nonclinical Evaluation of Pediatric Drug Products
Who Will Benefit: This webinar will provide valuable assistance to all personnel in: Pharmaceutical, Biotechnology, CROs and Research Facilities Conducting Clinical Trials including:
- Pediatric Affairs
- Pediatric Strategy
- Pediatrics
- Clinical Research
- Clinical Development
- Clinical Operations
- Clinical Affairs
- Medical Affairs
- Clinical Trial Management
