Paediatric Investigation Plan
Paediatric Investigation Plans: Burden or boost?
July 26 by Helen WinsorThe European Paediatric Medicines Regulation is well into its fourth year. Following early concerns that the challenges of compliance outweighed the benefits of the incentives offered, many new proced...
Preparing and Submitting Robust Paediatric Investigation Plans
May 20 by Pharma IQPharma IQ held a Q&A session with Karl-Heinz Huemer, PDCO Member and Clinical Assessor, Austrian Medicines Agency to gain a few insights into preparing and submitting robust PIPs... T...