
Joint Clinical Assessments and Reform of the EU Pharma Law
4 – 5 March 2024, live online training
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Summary
This interactive 2-day course will co-create actionable strategic recommendations to future proof clinical development, regulatory and market access strategies to ensure the success of innovative medicines in the changing European market.
Learning Objectives
- Discuss the strategic and operational impacts of Joint Clinical Assessments (JCAs)
- Develop next generation value evidence generation strategy for innovative medicines to succeed in the increasingly challenging European environment
- Understand the key changes to the EU pharmaceutical law, pricing and reimbursement
- Generate actionable recommendations to future-proof clinical development and regulatory strategy revisions
Key Topics
- Joint Clinical Assessments (JCA) – Analytical, organisational and process implications
- The crucial role of early dialogues and Joint Scientific Consultations (JSCs)
- The sweeping EU regulatory revisions and their impact on innovative medicines strategy
- Actionable recommendations to futureproof European clinical development and regulatory strategies
- The specific requirements of orphan, paediatric and advanced therapy medicinal products
- Next generation value evidence generation for market access and pricing success
Who should attend?
- Value, pricing and market access executives
- Marketing and commercial leaders
- Medical affairs executives
- Evidence Generation, Real-world Evidence
- Patient Centricity/Engagement and COA/PRO leadership
- Rare disease, orphan, paediatric and advanced therapy medicinal products leads
- Clinical development leaders and program directors
- Regulatory affairs executives
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
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.

Joint Clinical Assessments and Reform of the EU Pharma Law
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