Event Agenda
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DATE: Wednesday, 21 September 2022
TIME: 6:00 – 6:05 PM Welcome and Announcements
6:05 – 7:05 PM Program Presentation
7:05 – 7:30 PM Q & A
LOCATION: This is an ONLINE event on zoom virtual platform
Program Details
Thoughtful drug development and inclusion of pediatric patients in trials is critical to public health. Regulatory authorities such as the FDA and EMA have worked to address the problem of inadequate testing of drugs in pediatric populations and inadequate pediatric use information in drug labeling by requiring Sponsors to develop and gain agreement on pediatric drug development plans prior to health authority review of marketing applications. This presentation will review regulatory strategy considerations and processes for preparing pediatric investigational plans (PIPs) and initial Pediatric Study Plans (iPSPs).
Speaker Biography
Jennifer Grodberg, PhD, RAC-US (Jenny) is a regulatory affairs consultant with over 28 years’ experience in the pharmaceutical industry and over 18 years’ experience in regulatory affairs. She previously held positions as Sr. Vice President of Regulatory Affairs and Program Management at Forge Therapeutics, VP of Regulatory affairs at VenatoRx Pharmaceuticals, Senior Director of Regulatory Affairs at Trius Therapeutics, Inc. and Associate Director of Regulatory Affairs and Drug Development at TargeGen Inc. Jenny received Regulatory Affairs Certification in 2007, is a Fellow of the American Medical Writers Association (AMWA) and past-president of the AMWA Pacific Southwest Chapter. She currently chairs the SDRAN mentoring program and serves on the SDRAN Board as VP of Mentoring.
Registration Information:
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Contact
Pricing – Online – Registration (August 23, 2022 – September 20, 2022)
| Registrant Type | Price |
| Member | $10.00 |
| Lifetime | $10.00 |
| Non-Member |
$15.00
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Cancellation Policy
There will be no refunds for cancellations.
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