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BA/BE, Dissolution & Biowaivers

Use in development, submission and post approval changes

  • 11 – 13 June 2024
  • Online Live Stream | 9:00 CEST – 13:00 CEST
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BA/BE, Dissolution & Biowaivers

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online live

Training features

Fully online

All sessions of this unique course online

Live interaction

Live interaction options between the delegates and trainer

On any device

Available via mobile, tablet or laptop

Course description

This course will evaluate every aspect of BA/BE from the regulations and types of protocol studies to bioanalysis, statistical analysis and reporting. The course will also examine the different types of biowaivers and data needed to provide clear strategy to biowaiver application.

This practical course will provide understanding of BABE design including all practical aspects related to bioavailability & bioequivalence. Thanks to different case studies, participants will be understanding about the requirements of the BA/BE studies as well as the determination of pharmacokinetic parameters, the possibility of biowaivers and the related regulatory and legal aspects. In addition, the participants will learn about development of dissolution test and the need of dissolution to support BA/BE studies.

meet the training leader
Eric Beyssac | Speaker | Fleming
Linkedin
Prof. Eric Beyssac, Ph.D.
University professor
University Clermont Auvergne– France
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training

Brochure

Reveal the full schedule of the training as well as key topics, course objectives, key takeaways, special features, and the trainer bio!

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BA/BE Dissolution & Biowaivers online live training organized by Fleming_Agenda Cover
BA/BE Dissolution & Biowaivers online live training organized by Fleming_Agenda Cover
BA/BE Dissolution & Biowaivers online live training organized by Fleming_Agenda Cover
key training

Topics

Bioavailability and Bioequivalence

BA/BE design

Practical aspects

Statistical analysis

Specific cases & regulatory aspects

Development & application of in vitro dissolution methods

Dissolution compliance

Biowaiver principles

The use of different types of biowaivers

Regulatory & legal aspects of biowaivers

Specific case studies

Benefits of attending

  • Bioavailability/Bioequivalence
    • Understand the concepts of bioavailability and bioequivalence
    • Know when and how to perform bioequivalence studies for a generic
    • Identify intrinsic and extrinsic factors in bioavailability/bioequivalence studies
    • Know how to interpret results and statistical analysis
    • Understand the admissibility of data relative to bioequivalence for Module 5 of CTD
    • Ensure regulatory compliance when submitting your bioavailability studies
    • Discover the usual problems encountered during the implementation of these studies
    • Clarify regulatory demands on bioequivalence studies when filing for a biowaiver

  • Dissolution
    • Develop and apply in vitro dissolution methods during development and quality control
    • Understand the link between dissolution parameters and the characteristics of the active substance and pharmaceutical form
    • Understand the rationale for the data needed to support bioequivalence or biowaivers

  • Biowaivers
    • Acquire the basics of biowaivers and the biopharmaceutical classification system
    • Know the different types of biowaivers and the associated regulatory and legal aspects
    • Discuss the possibilities of biowaivers through case studies
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Contact us

Andrea Weber | Marketing Manager | Fleming
Linkedin
Andrea Weber
Sr. Manager for Pharma
Phone: +421 257 272 100
Email: event.inquiries@fleming.events

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