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Sharan Murugan
Jan 22 min read
UK MHRA Guidance: 150-Day Assessment for National Applications for Medicines & Procedures for UK Paediatric Investigation Plans (PIPs)
The UK Medicines and Healthcare Products Regulatory Agency (MHRA) continues to innovate in the regulatory space with updated processes...
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Sharan Murugan
Jan 13, 20241 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...
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Sharan Murugan
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"....
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