Paediatric Drug Development & Clinical Trials

    2022 dates TBC, online training


    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
    • How to interact with regulatory bodies
    • Understand requirements to address unmet therapeutic/diagnostic needs

    Key Topics

    • EMA & FDA Regulatory Requirements
    • PIP & iPSP
    • PREA v. BPCA Requirements
    • Waivers & Deferrals
    • Paediatric trial methodologies
    • Protocol Writing
    • Patient Recruitment & Ethical challenges
    • Company Strategies


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


    Clinical Assessor, Austrian Medicines & Medical Devices Agency; PDCO Member, EMA
    Dr. Huemer works at the Austrian Medicines & Medical Devices Agency, participating in many assessments of scientific advice procedures, paediatric investigation plans and centralized marketing procedures in different clinical areas. He is a SAWP full member since 2014 and a PDCO full member since 2013.
    Registration for this event has been closed. Dates for the next class will be announced soon.

    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