ATMP Clinical Trials – The Medicinal Product Life Cycle & Regulation

    19 – 20 September 2022, live online training

    Summary

    This 2-day course will provide you with a comprehensive overview of clinical, quality, regulatory and organisational aspects of clinical trials for Advanced Therapeutic Medicinal Products. You will receive a regulatory update, explore regulatory pathways and procedure types as well as recommendations for common hurdles.

    Learning Objectives

    • Regulatory expectations for ATMP products
    • Practical implementation of regulatory expectations & a comprehensive regulatory update
    • Understand the GxP requirements for ATMPs
    • Take advantage of the available regulatory advice
    • Understand different procedure types (legal, timetables, etc.)

    Key Topics

    • Regulatory: Overview, Framework, Expectations & 2022 Update
    • ATMP Procedures (Types; Centralised, National)
    • The Medicinal Product Life Cycle (ATMP)
    • GxP Requirements
    • Marketing Authorisation
    • Post- Authorisation/ Pharmacovigilance

    Who should attend?

    • Clinical Research Associates
    • Clinical Scientists
    • Clinical Operations Analysts
    • Clinical Diagnostic Specialists
    • Clinical Trial Managers
    • Regulatory Managers & Specialists
    • Drug Development Scientists
    • Quality & Compliance Associates

    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

    Medical Director at Premier Healthcare Germany - Board-Certified Consultant - National & International HealthCare Management
    Dr. Rensing studied biology and medicine biology and medicine at Tübingen, Heidelberg and Amherst, USA. During his clinical career he contributed to more than 40 clinical trials in all phases. He has worked in hospital management and more importantly in the pharmaceutical industry as well as at The Paul-Ehrlich-Institute (PEI) as a clinical assessor.

    ATMP Clinical Trials – The Medicinal Product Life Cycle & Regulation

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

    Online Participation
    1 450  Price incl. VAT: 1 450 
    Equivalent of approx. 1 561 USD.
    The price calculation in USD is informative and might slightly differ from your bank exchange rate
    .

    Price per delegate including:

    Online participation

    Online workbook & materials

    Certificate

    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.

    pharma learning leader

    Lydia Makori

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

    Training Details
    • Start Date
      19. September 2022
      02:00 PM Vienna time
      01:00 PM London time
      08:00 AM New York time
      05:00 AM Los Angeles time
    • End Date
      20. September 2022