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Informa
Starting 18 - 27 August 2020

LIVE Online Academy - 5 Sessions

Learn how to successfully design, implement and report bioavailability and bioequivalence studies for different formulation types

Course Overview

Bioavailability (BA) is defined as the rate and extent to which the unchanged active substance is absorbed and becomes available in the systemic circulation. Understanding bioavailability is essential during drug development as it is one of the fundamental properties of drug formulation. Information on bioavailability is also used to determine bioequivalence (BE) when submitting a generic dossier.

Through interactive sessions and multiple case studies, this course will evaluate every aspect of BA/BE from the regulations and types of protocol studies to bioanalysis, statistical analysis and reporting. Once completed you will have a solid understanding of bioavailability, supporting you in drug development. You will also have the confidence to develop and implement your own bioequivalence studies to ensure speedy generic approval.

The course will also examine key aspects of biowaivers such as the regulatory hurdles, types of biowaivers and data needed so you can save money and time with fast biowaiver applications.

Live Online Academies

Gain real-time access to a subject matter expert delivering online training in a structured virtual classroom environment. Live online academies are virtual versions of some of our most popular face-to-face courses, delivered in bitesize sessions of 1.5-3 hours online.

Over 5 sessions students will learn through:

  • Live interactive bitesize sessions
  • Direct interaction with the trainer during live sessions
  • Participation in interactive features within sessions including polls, Q&A, break out rooms, tasks, case studies, and more
  • Revisiting recorded sessions with unlimited access for 30 days
  • Interaction with peers during live sessions and through the online forum

Timings and dates are subject to change - final confirmation will be provided with login details. Delegates will receive login instructions within a week of the course start date. If you have any questions please contact lifesciences-training@informa.com.

What will you learn?


Key Definitions
Key Definitions

Understand the fundamentals of bioavailability, bioequivalence and biowaivers

BA/BE study
BA/BE study

Determine when a BA/BE study is obligatory

BA/BE protocol studies
BA/BE protocol studies

Identify the various BA/BE protocol studies that are used


Design Studies
Design Studies

Develop strategies for testing highly variable drugs and design studies for different types of formulation

Bioanalytical method validation and requirements
Bioanalytical method validation and requirements

Examine bioanalytical method validation and requirements in the US and EU

Pharmacokinetic parameters calculation
Pharmacokinetic parameters calculation

Learn to calculate pharmacokinetic parameters on various types of studies and formulations


Bioequivalence regulations
Bioequivalence regulations

- Assess the regulations in the EU, US, Russia, Brasil, China and Japan for bioequivalence studies to gain a global perspective and maintain compliance

Biowaiver regulations
Biowaiver regulations

Learn to interpret biowaiver regulations in the US and EU and meet compliance

Evaluation
Evaluation

Evaluating the risk associated with submitting a biowaiver

Who is this course for?

For professionals working in clinical drug development who formulate drugs. It is also a good course for those who work in QA in generic companies. Regulators would be interested due to BE data being used in variation applications.

CPD Certified

Engaging in Continuing Professional Development ensures that both academic and practical qualifications do not become out-dated or obsolete; allowing individuals to continually ‘up skill’ or ‘re-skill’ themselves, regardless of occupation, age or educational level. This course has been assessed and is CPD certified.

Delegates of our live online academies said...

94%
would attend another live online academy
97%
found the course beneficial to their day to day role
97%
would recommend the course to others