What is this event about?
Paediatric Investigation Plans (PIPs) are mandated by the European Medicines Agency (EMA) to ensure that medicines for children are included in the mainstream drug development process in Europe, rather than as an optional extra. This means that children benefit from more effective treatments and pharmaceutical companies will be rewarded for increased time and costs relating to paediatric drug development.
The Regulation (EC) 1901/2006 Medicinal Products for Paediatric Use, entered into force on 26 January 2007 and caused a massive paradigm shift in European drug development. Pharmaceutical companies must submit a Paediatric Investigation Plan to the Paediatric Committee (PDCO) at the EMA around the end of Phase One new drug testing in adults. But studies for children are different and require a huge amount of collaboration.
This Masterclass aims to present a holistic approach addressing the challenges encountered during the creation and life span of a PIP. Often legal, clinical and regulatory departments are in widely different locations. These personnel have their own specialist focus but may not appreciate the roles of and synergy needed between other teams. This is essential for producing successful PIPs and the paediatric studies they must perform to legally binding timelines.
We are excited that our Masterclass will be delivered through a combination of diversely skilled speakers who will give presentations, case studies and discussions. This is designed to help inspire delegates with an understanding of and a synergistic approach for successful paediatric drug development.
Where is the event?
This Masterclass will take place in central London, UK
Who would benefit?
Professionals from a variety of departments within Pharmaceutical and Contract Research Companies such as:
Corporate
Clinical Operations
Legal and Regulatory Affairs
Paediatric Project Teams
Quality and Ethical Assurance
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In association with
By attending this event you will be better able to:
Identify and address challenging issues within your PIP
Develop your understanding of the preparation process
Think “out of the box” for successful paediatric drug development
Link regulatory and clinical expertise for a joined up approach
Discover ways to further improve your current approach
Expand your network of paediatric colleagues and contacts
Who is leading this event?
Jane Lamprill, RN RSCN FICR Director,
Paediatric Research Consultancy
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Jane has 17 years experience as a Paediatric Research Sister (Senior Study Site Coordinator) managing both pharmaceutical and academic paediatric clinical trials. She founded Paediatric Research Consultancy in 2004 near Oxford UK. Her current roles are mainly 1) advising companies about practical, ethical and study management issues 2) providing informed consent/assent materials as a specialist children’s medical writer 3) Ethics review as member of the FP7 European Commission ethics panel 4) In-company training.
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Co-hosted by Steve Pinder, PHD, MTOPRA, Co-Director, Envestia
Masterclass agenda
Welcome and introductions Jane Lamprill, Paediatric Research Consultant Specialist Medical Writer for Children and Member FP7 Ethics Panel, Paediatric Research Consultancy Steve Pinder, Director, Envestia • PIP experience so far
• How to write a PIP
• Considerations for deferrals and waivers
• Regulatory update for PIPS and EMA
• Brief pediatric FDA update
• Helping to make your PIP work for you
• Current issues affecting PIPs
Child and Company friendly technology Jeremy Hague, Director of European Business Development, Xceleron Ltd • Gaining PK and Metabolism from small clinical samples using breakthrough ultra-sensitive analytics Clock Stop - Considerations for PDCO Jane Lamprill, Paediatric Research Consultant Specialist Medical Writer for Children and Member FP7 Ethics Panel, Paediatric Research Consultancy • Don’t promise what you cant deliver!
• Practical planning for smooth studies to bridge gap between PIP and family
• Ethical issues when planning paediatric trials and agreeing PIPS Putting PIP studies into action - linking theory to practice • linking theory to practice
• real world v PIP timelines
• paediatric studies in emerging countries - speed v challenges
• post marketing PIP commitments
Legal update for 1901/2006/EC Lorna Brazell, Partner, Bird & Bird • Overview of legal issues relating to the PIP and the patent extension reward Q&A panel discussion; PIP problem solving Jane Lamprill, Paediatric Research Consultant Specialist Medical Writer for Children and Member FP7 Ethics Panel, Paediatric Research Consultancy Lorna Brazell, Partner, Bird & Bird Steve Pinder, Director, Envestia Jeremy Hague, Director of European Business Development, Xceleron Ltd Key take home messages. Thanks and close of Materclass Jane Lamprill, Paediatric Research Consultant Specialist Medical Writer for Children and Member FP7 Ethics Panel, Paediatric Research Consultancy
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