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Thursday, July 1 • 10:00am - 11:00am
#409 SL: Recent Developments and Strategies in Pediatric Drug Development Documentation

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Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-21-638-L04-P; CME 1.00; IACET 1.00; RN 1.00

Recent focus on inclusion, diversity, and patient engagement in drug development have led to a number of new innovations and regulatory requirements that impact pediatric patients - and the documentation companies must develop and provide.

Learning Objectives

Formulate plans and strategies for pediatric documentation for their development program; Identify how to act in accordance with new pediatric regulatory requirements.


Theresa Shalaby, MSN, RN


Plans and Strategies for Pediatric Documentation
Theresa Shalaby, MSN, RN

Meet the International Children's Advisory Network, Inc. (iCAN)
Amy Ohmer

avatar for Theresa Shalaby

Theresa Shalaby

Senior Manager, Regulatory Services, Synchrogenix, A Certara Company, United States
Ms. Shalaby has 30 years of experience in the clinical research and drug development industry. Throughout those 30 years, she held several writing roles including lead author and contributing writer for investigator’s brochures (IBs), phase 2 and phase 3 clinical study reports (CSRs... Read More →
avatar for Amy Ohmer

Amy Ohmer

Director, International Children's Advisory Network (iCAN), United States
Amy Ohmer, Director of the International Children's Advisory Network, Inc. (iCAN), Amy specializes in creating collaboration through patient-centered programs by focusing on the needs of patients/families as partners within research and medical communities. She is an active advocate... Read More →

Thursday July 1, 2021 10:00am - 11:00am EDT
TBD Virtual Event Horsham, PA 19044
  04: MedAffairs-SciComm, Session