| Autor: |
Severin, Thomas, Corriol-Rohou, Solange, Bucci-Rechtweg, Christina, an Haack, Kristina, Fuerst-Recktenwald, Sabine, Lepola, Pirkko, Norjavaara, Ensio, Dehlinger-Kremer, Martine, Haertter, Sebastian, Cheung, S. Y. Amy |
| Zdroj: |
Therapeutic Innovation and Regulatory Science; 20240101, Issue: Preprints p1-9, 9p |
| Abstrakt: |
Background: Pediatric regulations enacted in both Europe and the USA have disrupted the pharmaceutical industry, challenging business and drug development processes, and organizational structures. Over the last decade, with science and innovation evolving, industry has moved from a reactive to a proactive mode, investing in building appropriate structures and capabilities as part of their business strategy to better tackle the challenges and opportunities of pediatric drug development. Methods: The EFGCP Children’s Medicines Working Party and the IQ Pediatric working group have joined their efforts to survey their member company representatives to understand how pharmaceutical companies are organized to fulfill their regulatory obligations and optimize their pediatric drug development programs. Results: Key success factors and recommendations for a fit-for-purpose Pediatric Expert Group (PEG) were identified. Conclusion: Pediatric structures and expert groups were shown to be important to support optimization of the development of pediatric medicines. |
| Databáze: |
Supplemental Index |
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