Bioequivalence and IVIVC, Pharmacokinetics Online live training course

        Bioequivalence and IVIVC

        TBC 2023, live online training

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        Summary

        This unique 2-day online training course provides practical insights into pharmacokinetics and bioequivalence studies as related to solid dosage formulations.

        Learning Objectives

        • How to design a bioequivalence study
        • The statistical design needed to get regulatory approval
        • Connecting the dissolution data to pharmacokinetics
        • The predictive power of pilot studies
        • The requirements for studies in fasting and fed state
        • Validation and compliance issues
        • What is the relationship between formulation and bioavailability?
        • What to look for when auditing a biostudy house in terms of validation
        • Project management of biostudies

        Key Topics

        • General Requirements for Biostudies
        • Establishing the Biostudy Statistical Design
        • Similarity, Comparability, and Correlation
        • Predictive Power of Dissolution and Alternatives to Full BE
        • Validation and Compliance Issues

        Who should attend?

        BA/BE managers, R&D managers, Pharmacokinetics scientists, IVIVC specialists, Formulation managers, Solid dosage formulators, Regulatory affairs managers

        Past participants

        • Clinical Pharmacologist, Boehringer Ingelheim
        • DMPK & Clinical Pharmacology Head, Basilea Pharmaceutica International
        • BE Assessor, Icelandic Medicines Agency
        • Director Analytical Development Drug Product, Idorsia

        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
        • Digital and LinkedIn certificates

        Trainers

        Dr. Paula Muniz
        Paula Muniz is a Senior Associate with Dynakin’s Drug Modeling & Consulting (DMC) group. She is a Doctor in Pharmacy at the University of Navarra with a PhD in cardiovascular pharmacology.

        Bioequivalence and IVIVC

        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
        1 650 € Price incl. VAT: 1 650 €
        Equivalent of approx. 1 833 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

        “Excellent work of the lecturer, good materials, clear explanations”
        Clinical Pharmacologist, Boehringer Ingelheim

        “Very well presented and easy to understand. The training material is great.”
        Solid State Chemist, Symeres

        “The training was well organised and very informative.”
        Manager Clinical Affairs, Stada

        “The really comprehensive content, trainer expertise and bringing real examples in to explain particular points.”
        Associate Director PBPK, Esqlabs

        “Very well organised and relevant to the requested topics. The presentation and the materials were clear and the presenter, Paula, showed excellent depth of knowledge in response to questions.”
        Global Director Medical Affairs, Advanz Pharma

        “Great training by someone with clearly a lot of experience in all the fields covered. Great!”
        Clinical Research Manager, Taro