Summary
This highly interactive course will discuss and co-create concrete, actionable strategic recommendations to support the regulatory and commercial success of novel OMPs and ATMPs in the rapidly changing EU landscape.
Who should attend?
- C-Suite, Chief Science, Operations and Commercial Officers
- Rare disease, OMP and ATMP executives and functional leads
- Clinical development leaders and program directors
- Regulatory affairs executives
- Value, pricing and market access executives
- Marketing and commercial leaders
- Medical affairs executives
- Real-world Evidence and COA/PRO leadership
Learning Objectives
- Understand the key changes to the EU OMP, ATMP, and paediatric legislations
- Generate actionable recommendations to future-proof clinical development and regulatory strategy to address these sweeping revisions
- Discuss the impact of joint EU clinical HTA – reduced burden or duplication of effort?
- Develop next-generation value evidence generation strategy for OMPs and ATMPs to succeed in the increasingly challenging European environment
Key Topics
- The sweeping EU regulatory revisions and their impact on OMPs and ATMPs
- Actionable recommendations to futureproof European clinical development and regulatory strategies to address these comprehensive regulatory changes
- Joint EU clinical HTA – reducing burdens and increasing access or duplication of work?
- Next-generation value evidence generation for OMP and ATMP market access and pricing success in the challenging European environment
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
David Schwicker has biopharmaceutical consulting expertise spanning more than 25 years. Founder of ORPHA Strategy Consulting, and former Vice President with PAREXEL International in the United States. David is a sought-after expert for accelerating marketing authorization, time to launch, early patient and market access of ATMPs.
Future-proofing Orphan Drug Strategies for Europe
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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