Future-proofing Orphan Drug Strategies for Europe online training

    Future-proofing Orphan Drug Strategies for Europe

    The sweeping changes of EU’s pharma reform: Significant implications for clinical, regulatory, and access strategies

    TBC 2023, live online training


    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


    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 full program agenda

    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.

    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 participation

    Online workbook & materials


    Revisit recorded sessions for 30 days

    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.

    Lydia Makori

    +421 222 200 543

    Training Details
    What participants said about Symmetric courses

    "I enjoyed the expertise of the trainer, a lot of concrete examples given and recent and relevant references shared."
    Head of Global Clinical Development & Operations, Novo Nordisk

    "Thank you for this informative session that brings together a lot of complex information in a condensed format."
    Clinical Scientific Program Lead, Abacus Medicine

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    Senior Development Pharmacist, Orion Corporation

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    Head of API and Contract Manufacturing, Zentiva Group

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    Drug Product Subject Matter Expert, Pfizer