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DIA 2021 Global Annual Meeting


Recent Developments and Strategies in Pediatric Drug Development Documentation

Session Chair(s)

Theresa  Shalaby, MSN, RN

Theresa Shalaby, MSN, RN

  • Sr. Regulatory Services Manager
  • Certara Synchrogenix, United States
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 Objective : Formulate plans and strategies for pediatric documentation for their development program; Identify how to act in accordance with new pediatric regulatory requirements.

Speaker(s)

Theresa  Shalaby, MSN, RN

Plans and Strategies for Pediatric Documentation

Theresa Shalaby, MSN, RN

  • Sr. Regulatory Services Manager
  • Certara Synchrogenix, United States
Amy  Ohmer

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

Amy Ohmer

  • Director
  • International Children's Advisory Network (iCAN), United States