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Jan 131 min read

EMA: Guidance on Paediatric Submissions & Scientific Guidelines with SmPC Recommendations

Developing drugs specifically for paediatric use comes with its own set of challenges, including ethical considerations, appropriate...

Jun 17, 20231 min read

EMA Guidance: Paediatric Submissions Via Syncplicity Web Client

Recently on 09 June 2023, the European Medicines Agency released updated guidance on "Paediatric Submissions Via Syncplicity Web Client"....