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Pediatric Safety Plan (PSP) in the US and Pediatric Implementation Plan (PIP) in the EU

January 29, 2018 @ 10:00 am - 11:30 am

Live Webinar
Date: Monday January 29, 2018
Time: 10:00 AM ET | 7:00 AM PT
Duration: 90mins with Q&A

 

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. Attend this webinar to learn the requirements that must be addressed before submitting your marketing application.

Areas Covered During The Session

  • Review of regulatory requirements for a PSP & PIP
  • Timing of PSP agreement and PIP approval submission of data and information on pediatric patients
  • Differences between US and EU requirements
  • Considertions for pediatric study design
  • Managing the proposal with the regulatory agencies

Peggy J. Berry, MBA, RAC, President & CEO, Synergy Consulting 

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).

Why You should Attend The Session

Learn how to prepare a PSP and PIP. Review of briefly what the regulatory requirements and timing are for both regions.

This webinar will be beneficial for individuals supporting clinical trials,regulator affairs, compliance,clinical and quality assurance and anyone required to understand clinical trial management

  • Directors
  • Managers
  • Supervisors
  • Auditors
  • Clinical investigators, site management and contracting personnel
  • Clinical operations
  • Project managers
  • Data management
  • Medical writers
  • Compliance officers
Register Today!

 

Single Registration
Single Attendee: $195.00 + HST CAD per session
Single attendee refers to single participant at a single computer/login.


Group Registration
Group of 5 or less per location: $400.00 + HST CAD per session
Group of 6 to 10 attendees per location: $750.00 + HST CAD per session
Group of 11 to 20 attendees per location: per location: $1250.00 + HST CAD per session

Group rates only apply to candidates who wish to have more than one attendee, but will be attending the webinar from a single computer/login. If multiple candidates wish to login at different locations, it will be considered as a separate additional registration and will require more than one webinar login information. Also note that one login information will only be valid on one computer.


Please contact us at webinar@ipacanada.com for multiple-location group rates or any other enquiries.

 

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Details

Date:
January 29, 2018
Time:
10:00 am - 11:30 am

Venue

Live Webinar