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Better Medicines for Children: Lessons Learnt and Share Learnings at the EFGCP Annual Paediatric Conferences
Solange Corriol-Rohou1, Sabine Ingeborg Fürst-Recktenwald2, Elin-Haf Davies3
1Sr Regulatory Affairs & Global Policy Director, AstraZeneca R&D, Paris, France. solange.rohou@astrazeneca.com.
Insights
The European Forum for Good Clinical Practice (EFGCP) annually hosts a Paediatric conference, fostering collaboration among stakeholders to enhance children's access to innovative medicines. Virtual formats did not hinder participation or the sharing of crucial insights for paediatric drug development.
Area of Science:
- Pediatric Pharmacology
- Regulatory Science
- Drug Development
Background:
- The European Forum for Good Clinical Practice (EFGCP) Children Medicines Working Party has a long history of organizing annual Paediatric conferences.
- These conferences were historically co-organized with the European Medicines Agency and the Drug Information Association (DIA).
Purpose of the Study:
- To provide a platform for diverse stakeholders, including regulators, health technology assessment (HTA) bodies, patient representatives, academia, and industry, to share knowledge.
- To raise awareness of new regulatory requirements aimed at optimizing paediatric drug development.
- To discuss challenges and solutions in advancing paediatric medicines.
Main Methods:
- Annual conferences organized by the EFGCP Children Medicines Working Party.
- Past collaborations included the European Medicines Agency and the Drug Information Association (DIA).
- Recent conferences (2021, 2022) were held virtually due to the COVID-19 pandemic, featuring themes like 'Challenges and Solutions' and 'Progress made and Continuing Challenges'.
Main Results:
- Despite the shift to virtual formats, the conferences maintained high attendance and value.
- Broad stakeholder participation was achieved, covering regulators, HTA bodies, patients, academia, and industry.
- A comprehensive overview of key issues impacting children's access to innovative medicines was generated.
Conclusions:
- Virtual conferences can effectively facilitate stakeholder engagement and knowledge sharing in paediatric drug development.
- Continued collaboration and discussion are essential for addressing challenges and improving access to novel medicines for children.
- The annual EFGCP conference remains a vital forum for advancing paediatric medicine development and regulatory science.
Abstract:
For many years, the European Forum for Good Clinical Practice (EFGCP) Children Medicines Working Party has organised a Paediatric conference annually. In the past, this event was organised jointly with the European Medicines Agency who was used to host it, along with the Drug Information Association (DIA). This conference is the opportunity for all involved in paediatric drug development, i.e., regulators, HTA bodies, patients' representatives, academia and industry, to share learnings and raise awareness about new regulatory requirements of interest to optimise paediatric drug development. The theme of the 2021 conference was "Challenges and Solutions - the path forward" while in 2022 it focused on "Progress made and Continuing Challenges". Because of the COVID-19 pandemic these two conferences were organised virtually. However, this has not impacted the attendance and value of the conference, since because of a broad and attractive agenda there was a wide stakeholder participation, which provided a compendious overview of the leading issues to improve children's access to innovative medicines.
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