Advancing International Pediatric Clinical Research Webinar Series

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The MRCT Center is delighted to announce a 5 part virtual conference series to advance the design, review, oversight, and conduct of global pediatric clinical trials. Ensuring all children have access to safe and effective medicines is contingent upon the conduct of trials that include them. For many pediatric conditions, disease incidence is low and the pool of potential participants small; conducting multisite and multinational pediatric studies is necessary to secure sufficient enrollment for completion. Given the dearth of relevant data and the challenges of working across jurisdictions, harmonized approaches for pediatric research are necessary.

To ensure wide global relevance and participation, each conference will be offered twice to better accommodate individuals across international time zones, each with the same general agenda but different speakers to hear a variety of opinions.

This series is supported by an FDA Scientific Conference Grant.

The first conference in the series was a three-hour webinar that focused on applying lessons learned—those sustained and those abandoned– during the COVID-19 pandemic to future work with children in clinical trials. We were delighted to host the keynote speakers:

October 6, 2021

Keynote Speaker:
Dr. Peter Marks
Director, Center for Biologics
Evaluation and Research (CBER),
U.S. Food and Drug Administration (FDA)

USA

📄October 6, 2021 session Agenda

🎥  Watch Day 1 webinar recording

⬇️   Download Day 1 slides

October 7, 2021

Keynote Speaker:
Prof. Mojisola Christianah Adeyeye
Director General, National Agency for Food and Drug Administration and Control (NAFDAC)
Nigeria

📄October 7, 2021 session Agenda

🎥  Watch Day 2 webinar recording

⬇️   Download Day 2 slides

 

We would appreciate feedback on these webinars. Please complete the survey to help us plan future webinars in this series that are both informative and convenient.

We invite you to browse the Day 1 & Day 2 speakers’ brief biographical details.

Each keynote speaker was followed by two moderated panel discussions to:

  1. Deliberate the appropriateness and timing of initiating trials in children, and the different age groups within the broad scope of “children,” using lessons learned from COVID-19 and applying that learning to future pediatric trials.
  2. Address infrastructure, both new and adaptations to existing structures, needed to conduct efficient and ethical pediatric clinical trials on a global scale.

This project is supported by the FDA (R13) Scientific Conference Grant Program.