Boston Professional Events List


Live Webinar Pediatric Safety Plan (PSP) in the US


Date
Oct 12, 2017 - 01:00 PM
Organizer
wcsseminars
Venue
Onlinewebinar
Location
WCS Consulting Inc.3190 Stirling Rd, Unit K4, Hollywood, FL 33021,

Hollywood,
FLORIDA,
United States,
ZIP: 33021
Phone: 347 282-5400

Ticket Price: $179 One Dial-in One Attendee, $395 Group, $249 Recorded, $295 CD/DVD
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.
 
Areas Covered
  • 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 Benefi
  • Directors
  • Managers
  • Supervisors
  • Auditors
  • Clinical investigators, site management and contracting personnel
  • Clinical operations


Speaker Details


Peggy J. Berry, MBA, RAC, is the President & CEO at Synergy Consulting where she provides consulting services to companies in all aspects of drug development. She also provides group and one-on-one training in drug development, regulatory affairs and project management topics. Prior to founding Synergy Consulting in 2015

Event Categories
Keywords: Educationa




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