Live Webinar Pediatric Safety Plan (PSP) in the US
01:00 PM EDT | 10:00 AM PDT | 12:00 PM CDT Duration 60 Minute
Webinar Includes : All the training handouts , Certificate by the Speaker ,Q/A and 60 Min Live Webinar
"Hear By Peggy J. Berry, MBA, RAC, is the President & CEO at Synergy Consulting "
Learn how to prepare a PSP
Within the US, it is required that all products account for safety in pediatric patients. This may include completing a clinical study, extrapolating from adult data, or known information about the molecule. Join this webinar to learn the requirements for the Pediatric Safety Plan (PSP) in the US and the required timing for addressing the matter.
Why You should Attend The Session
Learn how to prepare a PSP and briefly what the regulatory requirements contrast with the EU Pediatriac Plan.
- Review of regulatory requirements for a PSP
- Timing of PSP agreement and submission of data and information
- Alternatives to creating a full PSP
- Major difference between US and EU requirements
- Considertions for pediatric study design
- Managing the proposal with the regulatory agency
Who will Benefit
- Clinical investigators, site management and contracting personnel
- Clinical operations
- Project managers
- Data management
- Medical writers
- Compliance officers
Industries who can attend
This workshop will be beneficial for individuals supporting clinical trials, regulatory affairs, compliance,clinical and quality assurance and anyone required to understand clinical trial management