Summary
This unique online training course focuses on methods enabling to leverage patient engagement, novel rare disease trial designs, regulatory incentives and realworld evidence to accelerate the development, approval and patient access of innovative Advanced Therapy Medicinal Products (ATMPs), including autologous and allogeneic gene therapies, tissue engineered products and somatic cell therapies.
Learning Objectives
- Explore the opportunities of digital and big data to accelerate discovery, development, regulatory approval and market access for ATMPs
- Gain insight into the most recent methodologies for faster, smaller, smarter clinical trials robust enough for marketing application
- Discuss strategies to limit the number of patients and the placebo exposure of patients in pivotal clinical trials in rare and ultra-rare conditions
- Discover the newest regulatory approaches for gene and cell therapies
- Consider the crucial role of patient engagement throughout the lifecycle
- Analyse the current market access challenges for ATMPs
- Explore innovative strategies that integrate real-world evidence (RWE)
Key Topics
- An Introduction to Advanced Therapy Medicinal Products
- Accelerated Development Strategy for ATMPs
- “Fast to Patient” Regulatory Strategy
- ATMPs Pricing and Market Access
- Gene Therapy Safety & Risk Evaluation
- ATMPs Interactive Case Studies
Who should attend?
Heads of R&D, Global program leads, Regulatory executives, C-level executives, Senior business development strategists, Portfolio executives, Pricing and market access executives, Medical affairs executives, Marketing and Commercial executives, Finance executives, Patient advocates, Epidemiologists, Outcomes researchers, Health economists, Digital health specialists, Big data and RWE researchers
Past participants
- Global Clinical Leader, Bayer
- Senior Fellow in Cell & Gene Therapy Development, Ferring
- Technical Applications Scientist, Fujifilm Irvine Scientific
- Regulatory Affairs Officer, Genethon
- ATMPs Regulatory Affairs, Novo Nordisk
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
- Digital and LinkedIn certificates
Trainers
