Summary
This 2-day course provides a comprehensive overview of the medical, regulatory, ethical, organisational, and practical aspects of designing and conducting clinical trials involving children. It is tailored to help professionals navigate the regulatory landscape and maintain best practices throughout the trial process. You will gain essential tools and knowledge to conduct paediatric clinical trials responsibly and effectively.
Learning Objectives
- Regulatory expectations for paediatric trials (EMA, FDA)
- Practical implementation of regulatory expectations
- Understand the specific requirements of the paediatric population
- Tools for generating data in paediatric patients
- How to design a paediatric study
- Overcome the challenges of paediatric patient recruitment
- How to interact with regulatory bodies (Perspectives of a long time EMA and AGES assessor)
- Understand requirements to address unmet therapeutic/diagnostic needs
- Discuss how to overcome paediatric complexities, including scientific, legal, ethical and regulatory
Key Topics
- Comprehensive regulatory update (EMA PIP, FDA iPSP, PREA, BPCA)
- Waivers & Deferrals
- Requirements for unmet therapeutic/diagnostic needs
- Paediatric trial methodologies & Protocol Writing
- Clinical & non-clinical data requirements
- Study designs, endpoints, comparators, dosing
- Patient Recruitment & Ethical challenges
- Company Strategies & Regulatory outlook
- Extrapolation & Modelling & Simulation
- Post-marketing / Real World Data
- Regulatory Interactions
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 7 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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