PIP
Paediatric Drug Development - Free Online Resource Center
September 04 by Pharma IQThe Paediatric Drug Development Resource Center covers an entire host of topics, ranging from Implementation lessons about the consistency Paediatric Interventional Plans Learning from acro...
Increasing Inspection Coverage in the Wake of Globalisation; European Medicines Agency's Fergus Sweeney
March 08 by Fergus SweeneyIn support of our European activities, the European Medicines Agency (EMA) also has a role in the harmonisation of inspection procedures, and consequently we run clinical and manufacturing pra...
European Medicines Agency's Fergus Sweeney: Increasing Inspection Coverage in the Wake of Globalisation
November 07 by Pharmaceuticals & Biotechnology EditorWherever you sit in the world as a regulator, most of the clinical trials you receive in marketing applictaions, most of the manufacturing that takes place for products is taking place in terrioties...
Integrated Paediatric Drug Development
January 27 by Pharma IQSince 2008 pharmaceutical companies looking to develop drugs for use by children have been required to submit Paediatric Investigation Plans (PIPs) to the European Medicines Agency. PIPs Despi...
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...
Examining Asthma Exacerbation within Children and Disease Management
May 20 by Pharma IQDr Chad Oh, Director Respiratory & Inflammatory Diseases, MedImmune speaks to Pharma IQ about asthma exacerbations in children and therapeutic approaches, ahead of the 2nd Asthma & COPD co...
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...