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Recent Developments and Strategies in Pediatric Drug Development Documentation
Session Chair(s)
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)
Plans and Strategies for Pediatric Documentation
Theresa Shalaby, MSN, RN
Certara Synchrogenix, United States
Sr. Regulatory Services Manager
Meet the International Children's Advisory Network, Inc. (iCAN)
Amy Ohmer
International Children's Advisory Network (iCAN), United States
Director