Monday, September 27, 2021

Advancing the Development of Pediatric Therapeutics (ADEPT) - FDA Workshops on Pediatric Drug Developments

Each year, the FDA's Division of Pediatrics and Maternal Health in collaboration with the University of Maryland CERSI organized an annual public workshop to discuss the issue related to pediatric drug development. Starting in 2014, it has organized 7 public workshops (no event for 2020 due to Covid-19). 

           Advancing the Development of Pediatric Therapeutics (ADEPT)

ADEPT 7

2021

Complex Innovative Trial Design

"Advancing the Development of Pediatric Therapeutics Innovative Trail Design"

ADEPT 6

2019

Pediatric Patient Perspectives

 

Pediatric Clinical Trial Endpoints for Rare Diseases With a Focus on Pediatric Patient Perspectives

NOVEMBER 12, 2019

ADEPT 5

2018

Pediatric Pharmacovigilance

Advancing Pediatric Pharmacovigilance Public Workshop

AUGUST 13, 2018

ADEPT 4

2017

Big data

 

Application of "Big Data" to Pediatric Safety Studies

ADEPT 3

2016

Long-Term Pediatric Safety Studies

Successes and Challenges of Performing Long-Term Pediatric Safety Studies:

Pediatric Drug Development Regulatory Considerations

International Collaborations in Pediatrics: FDA and EMA growing together

International Considerations for Pediatric Master Protocols

 

ADEPT 2

2015

Long-term Neurocognitive Development in Pediatrics

Evaluation of Long-term Neurocognitive Development in Pediatrics

ADEPT 1

2014

Pediatric Bone Health

 



For this year (2021), the 2-day public workshop was titled “Advancing the Development of Pediatric Therapeutics Complex Innovative Trial Design”. The purpose of the workshop was to discuss opportunities for leveraging complex and innovative trial designs, understand the challenges with their applications, and develop solutions on how challenges in the designs can be overcome. 

The workshop specifically focused on two topics of interest: 
  • bridging biomarkers in pediatric extrapolation 
  • Bayesian techniques in pediatric studies. 
In addition, the workshop allowed for an open dialogue around the use of these approaches among regulators, industry, academia, and patient organizations.

The presentation slides & webcast video links from the workshop are now all available.

SEPTEMBER 1 - 2, 2021

 


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