paediatric clinical trials training EMA FDA regulatory guidance

        Paediatric Drug Development & Clinical Trials

        New Dates TBA, live online training

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        Summary

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

        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

        Who should attend?

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

        Past participants

        • Clinical Project Scientist, Idorsia
        • Sr. Director Clinical Development Leader, Teva
        • Clinical Operations Manager, Gilead Sciences
        • Early Development Scientist, Boehringer Ingelheim
        • Director Clinical Scientist, Jenssen Biologics
        • Senior Director Clinical Operations, Fresenius Kabi
        • Trainee Clinical Science, Johnson & Johnson

        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. Karl-Heinz Huemer
        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.

        Paediatric Drug Development & Clinical Trials

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

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        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

        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
        Request in-house
        What participants said about this course

        "Real examples, and very experienced speaker with relevant advice and answers to all questions!"
        Director, Clinical Operations, Gilead Sciences

        "Given that the trainer works for EMA, the inside knowledge of the trainer was great."
        Senior Manager, Clinical Trials, Abbvie

        "I enjoyed the course very much. It was really interesting."
        Clinical Trial Manager, Om Pharma

        "The content was assembled nicely and gave a broad overview which was useful for a beginner as myself."
        Clinical Project Scientist, Idorsia