Joint Clinical Assessments and Reform of the EU Pharma Law
Joint Clinical Assessments and Reform of the EU Pharma Law

Course Description

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.
  • 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
  • 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

Joint Clinical Assessments and Reform of the EU Pharma Law

4 - 5 March 2024, Live Online Training
€1.650,00
David Schwicker

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.

START TIMES

1:00 PM Vienna time

12:00 PM London time

7:00 AM New York time

4:00 AM Los Angeles time

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Course Description

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.
  • 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
  • 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

"Trainer is very competent and has the complete knowledge of the matter."

– Senior Process Expert, B. Braun

"It is not at all frequent to find this grade of preparation and reaction to specific cases such as the ones presented. I'm enthusiastic! Thanks really."

– Tech Transfer Lead, Novartis

"Thank you for sharing all the links and informative material. Very professional organization and execution."

– Manufacturing Manager, Thermo Fisher Scientific

"The trainer was very knowledgeable about the topics and was able to answer all questions."

– Drug Product Subject Matter Expert, Pfizer

"Excellent work of the lecturer, good materials, clear explanations."

– Clinical Pharmacologist, Boehringer Ingelheim

Joint Clinical Assessments and Reform of the EU Pharma Law

Download the full training agenda to reveal complete session details, training takeaways, case studies, daily schedule, special features and full trainer bio.

Medical-Devices-Certificate-Course

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