Meeting regulatory and patient expectations in developing acceptable pediatric formulations
Over the last decade global regulatory bodies have increased the pressure on industry to develop authorised medicines for pediatric populations in order to improve and protect child health. Frameworks have been put in place to incentivise companies to deliver on their obligations, however how successful has adoption been? What challenges and opportunities remain for development teams?
This webinar will review current EU and US regulatory expectations and processes for the development and approval of pediatric drug products. The reality of today’s “custom and practice†in industry will be described and barriers to success discussed.
There will be a focus on the unique considerations and requirements for pediatric drug product design in order to develop palatable, acceptable drug products for target age group(s). Strategies and case studies will be shared illustrating how key challenges can be overcome:
- Formulation development and taste masking
- Integrated human taste and PK assessments using adaptive study designs
- Manufacture and supply of drug products for global pediatric trials using a real-time GMP platform
Register now to avoid missing out on this informative webinar on pediatric product development. We hope to see you in the live session!
Presented by
Jenny Walsh,
Director, Jenny Walsh Consulting Ltd
Jenny graduated from the University of Wales Institute of Science and Technology, Cardiff, with a B. Pharm (Hons) in Pharmacy and was awarded a PhD by the University of Nottingham in 1993. Jenny has over 20 years’ experience in the Pharmaceutical and Consumer Healthcare Industry, where she held roles in Pharmaceutical Development and Medical Affairs (GlaxoSmithKline, Napp Research Centre, The Boots Company, Reckitt Benckiser and AstraZeneca). Her key areas of expertise include the formulation of oral dose forms and the development of pediatric medicines; she has actively contributed to over 25 global pediatric development projects, including Paediatric Investigation Plans (PIPs) and Pediatric Study Plans (PSPs), and was responsible for the successful delivery and agreement of an EU FP7 funded PIP (LENA).
Jenny is a founder member of the European Paediatric Formulation Initiative (EuPFI), a consortium of members from academia, hospital pharmacies and the pharmaceutical industry, with a shared interest in the development of medicines for children, and has co-authored papers on behalf of this group. Since leaving AstraZeneca, Jenny has been working as a consultant offering specialist CMC pharmaceutical consultancy support to the pharmaceutical, biotechnology and healthcare industries, with a particular focus on pediatric product development.
Peter Scholes,
Chief Scientific Officer, Quotient Clinical
Peter read Pharmaceutical Sciences at the University of Nottingham, UK, gaining his PhD in 1993. Peter enjoyed various roles for 3M Pharmaceuticals & 3M Drug Delivery Systems, before joining Quotient Clinical in 2007 to develop and build the Pharmaceutical Sciences group. He has been instrumental in identifying and implementing the innovative and flexible benefits of integrating pharmaceutical development and clinical testing in early research.
Peter was appointed to the position of CSO in March 2013 where he now has responsibility for the scientific strategy and leadership for the organisation. Peter has previously served as a committee member for the UK Controlled Release Society and APS Biopharmaceutics focus group and in 2013 set up a GastroPlus user group with industry colleagues as a discussion forum for PBPK modelling and simulation science. In 2010, Peter was named one of PharmaVOICE’s 100 most inspiring people in the life-sciences industry. He was appointed as an Honorary Professor in Pharmaceutical Sciences at Nottingham University in August 2015.
