Summary
This 2-day course provides an overview of medical, regulatory, ethical, organisational and practical aspects of designing and performing clinical trials with paediatric patients. It is designed to help you navigate the regulatory landscape and maintain sound practices in patient recruitment, protocol writing.
Learning Objectives
- EMA & FDA expectations for paediatric clinical trials
- Practical implementation of regulatory expectations
- How to design a paediatric study
- How to utilise social media, advocacy groups and work effectively with children’s hospitals
- Overcome the challenges of paediatric patient recruitment
- How to interact with regulatory bodies
- Understand requirements to address unmet therapeutic/diagnostic needs
Key Topics
- EMA & FDA Regulatory Requirements
- PIP& iPSP
- PREA v. BPCA Requirements
- Waivers & Deferrals
- Paediatric trial methodologies
- Protocol Writing
- Patient Recruitment & Ethical challenges
- Company Strategies
Who should attend?
- Clinical Research Associates
- Clinical Scientists
- Clinical Operations Analysts
- Clinical Diagnostic Specialists
- Clinical Trial Managers
- Regulatory Managers & Specialists
- Drug Development Scientists
- Paediatric Drug Formulators
- Quality & Compliance Associates
Past participants
- Clinical Project Scientist, Idorsia
- Sr. Director Clinical Development Leader, Teva
- Clinical Operations Manager, Gilead Sciences
- Early Development Scientist, Boehringer Ingelheim
- Director Clinical Scientist, Jenssen Biologics
- Senior Director Clinical Operations, Fresenius Kabi
- Trainee Clinical Science, Johnson & Johnson
- VP, Head of Regulatory Science, Oxford Biomedica
- Regulatory Affairs Manager, OM Pharma
- Global Trial Manager, Novo Nordisk
- Regulatory Strategist, Merck Healthcare
Our online training experience includes
- Our client zone – a single source for all training materials as well as pre and post-training communication
- Live interactive format via the Zoom platform
- Direct interaction with the trainer
- Q&As, case studies, polls
- Revisit recorded sessions for 30 days
- Training in digital format
- Digital and LinkedIn certificates
Trainers
Dr. Huemer received his MD in medicine at the Medical University of Vienna and his PhD in Biology at the University of Vienna and subsequently specialized in Medical Physiology, followed by a long medical career in research, teaching, medical practice. Between 2007 - 2023 he worked at the Austrian Medicines & Medical Devices Agency.
Paediatric Drug Development & Clinical Trials
Download the full training agenda to reveal complete session details, training takeaways, case studies, daily schedule, special features and full trainer bio.
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