ATMP Clinical Trials – The Medicinal Product Life Cycle & Regulation

    2023 dates TBC, 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

    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.
    Prof. Schönermark studied Medicine at the universities of Göttingen, Munich, Heidelberg, London and Cape Town After PhD, and spent post doc time and various stays abroad, including at Columbia University in New York and Dartmouth Medical School, Hanover NH, Specialist examination for ENT medicine and activity as Managing Senior Physician at the Ear, Nose, Throat Clinic Hannover Medical School followed by further training in systemic therapy Postgraduate Certificate in Neuro Leadership.

    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. 1 611 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