Paediatric Drug Development & Clinical Trials

    9 – 10 September 2021, online training

    Summary

    This 2-day course provides an overview of medical, regulatory, ethical, organisational and practical aspects of designing and performing clinical trials with children. It is designed to help you navigate the regulatory landscape and maintain sound practices in recruiting and protocol writing.

    Who should attend?

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

    Learning Objectives

    • EMA & FDA expectations for paediatric clinical trials
    • Practical implementation of regulatory expectations
    • How to design a paediatric study
    • How to utilise social media, advocacy groups and work effectively with children’s hospitals
    • Overcome the challenges of paediatric patient recruitment
    • Understand the legal, administrative and biological issues with the term “child”

    Key Topics

    • EMA & FDA Regulatory Requirements
    • Paediatric trial methodologies
    • Protocol Writing
    • Patient Recruitment & Ethical challenges
    • Company Strategies

    Programme

    • Training materials will be provided in digital form
    • All delegates will receive digital and LinkedIn certificates

    Trainers

    Paediatric Drug Development & Clinical Trials Consultant
    Dr. Klaus Rose held various positions in R&D and medical affairs of progressive responsibility, eventually becoming Global Head Paediatrics at Novartis and later held the same position in Roche. He later joined Granzer Regulatory Affairs as Principal Consultant. Since 2011 Klaus has been an independent consultant for paediatric drug development and clinical trials.
    Online Participation
    1 450 Price incl. VAT: 1 450

    Price per delegate including:

    Online participation

    Online workbook & materials

    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.

    Lydia Makori

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

    Training Details