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

    Joint Clinical Assessments and Reform of the EU Pharma Law

    4 – 5 March 2024, live online training

    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 training agenda

    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.

    Online Participation
    1 650  Price incl. VAT: 1 650 
    Equivalent of approx. 1 849 USD.
    The price calculation in USD is informative and might slightly differ from your bank exchange rate
    .

    Price per delegate includes:

    Online workbook & materials

    Access to client zone

    Recorded sessions for 7 days

    Certificate

    PC, microphone, camera, stable internet connection and the Zoom application.

    Yes, we will make every effort to ensure best possible interaction. You will see the slides, interact with the trainer and fellow participants. Questions and group exercises will be facilitated through the online meeting platform.

    Yes, you can transfer the registration to a colleague at any time.

    Yes, you may transfer your registration to a different event up to one month before the scheduled dates, provided the training fee has been paid in full.

    pharma learning leader

    Lydia Makori

    l.makori@symmetric.events
    +421 222 200 543

    Training Details
    • Start Date
      4. March 2024
      01:00 PM Vienna time
      12:00 PM London time
      07:00 AM New York time
      04:00 AM Los Angeles time
    • End Date
      5. March 2024
    What participants said about Symmetric courses

    "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

    "Practical examples were extremely useful and well presented."
    Senior Development Specialist, Bioton

    "Diving into the case studies and the ensuing discussion and learnings were great."
    Regulatory Affairs Specialist, Csl Behring

    "Excellent work of the lecturer, good materials, clear explanations."
    Clinical Pharmacologist, Boehringer Ingelheim

    "You succeed only when you are trained enough! Trust Symmetric's Training Team to achieve your goals."
    Analytical Developer, Gedeon Richter

    "Thank you for sharing all the links and informative material. Very professional organization and execution."
    Manufacturing Manager, Thermo Fisher Scientific

    "Very well organized event. Thanks and hope to work-learn from you again soon."
    Deputy Manager of Solid Dosage Forms Plant, Gedeon Richter

    "Many thanks for the invitation, organization of the training and the atmosphere. I found the course very well organised and presented."
    Formulation Manager, Curia