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.

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 Benefit

  • Directors
  • Managers
  • Supervisors
  • Auditors
  • 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 

Speaker Profile

Peggy J. Berry.

MBA, RAC,President & CEO, Synergy Consulting (Ex-FDA Official)

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, she was Vice President of Regulatory Affairs at Insmed (2/2015-5/2015) where she was responsible for the development and implementation of global regulatory strategies and the management and oversight of the regulatory affairs department. Prior to Insmed, she was Vice President of Regulatory Affairs and Quality at Amarin (3/2009-2/2014). She has also held a variety of senior level positions at Dyax (5/2006-3/2009), MGI Pharma (now Eisai; 7/2005-5/2006), AstraZeneca (10/2001-7/2005), and Dey Pharma (now Mylan; 12/1997-10/2001). She has also held Regulatory Affairs roles within two clinical contract research organizations (ILEX Oncology and Cato Research Ltd; 1992-1997) and has worked in review divisions at the FDA (1985-1992). In addition, Ms. Berry consults for a number of companies in the regulatory and quality area, conducts a number of training courses, and is active in the Regulatory Affairs Professionals Society. She is the editor of the 2010 book "Choosing the Right Regulatory Career" (RAPS, MD) and author of the 2011 book "Communication & Negotiation" (RAPS, MD).

Back to Top