Paediatric Drug DevelopmentCOURSE CALENDAR
What Is Paediatric Drug Development Training?
This course is ideal for you if you need to be on top of the new EU paediatric drug development regulations that came into force in January 2007. It covers not only the regulations but also the medical and scientific background, enabling delegates to gain an all round understanding of this critical area. By the end of the course delegates will be able to understand the regulatory requirements introduced in the new regulations, together with the associated commercial incentives. Assess which products are affected and when. Appreciate the ethical issues involved. Take a science-based approach to compiling a Paediatric Investigation Plan. Evaluate formulations for use in children. Understand the complementary roles of PK, PD, safety and efficacy data. Plan the timing of paediatric development on the basis of ethical and scientific principles together with the concept of deferment.
Who Should Attend
Any person who requires the need to be trained in Paediatric Drug Development through the course of their normal working duties. This course is suitable for anyone working in the Pharmaceutical arena or Industrial sector, pre-requisites may be required.
- Why develop drugs for children?
- The medical background
- The social need
- The new regulatory requirements
- The new commercial incentives
- When is it NOT needed? How to do it
- Ethical issues
- The Paediatric Investigation Plan
- The importance of formulation
- Pharmacovigilance When to do it
- Planning the development
- Conducting the studies
- Submitting the results The regulatory processes
- Submitting the PIP
- The Paediatric Committee
- Waivers and deferments
- Free scientific advice
- Choice of incentive for patented products
- PUMA for off-patent products
- Updating of current authorisations.
Available onsite or nationwide at any of over 50 centres, see below our open course availability. Alternatively, call 0844 335 8882.
The Paediatric Drug Development course is accredited by the most recognised certificating body in the UK and supported by certification and credit card sized ID cards produced by XYZ Training Group - one of the UK's largest dedicated Industrial training organisations.
We train in excess of 100,000 delegates per year. For more information, please make your enquiry using the form below. The XYZ Training Group Customer Charter ensures that all enquiries are responded to the same day.
Available on client premises as an in-house course or at one of training venues, provided minimum delegate numbers are achieved. Whatever your requirement, simply complete the enquiry form below and we'll send you our quotation by return.
Make A Paediatric Drug Development General Enquiry Here
Complete the form below and we'll send you some training options and / or a quote by return. Please only use this form if you are interested in Paediatric Drug Development courses. For all other enquiries, please use the general contact page, refine your search above or call us on 0844 335 8882.