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.
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
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
