Trainings By Informa Markets
Informa


Bioavailability and Bioequivalence (BA/BE)

11 Aug - 12 Aug 2021


Workshop Overview

Bioavailability and Bioequivalence studies play a major role in the drug development phase for both new drug products and their generic equivalents, and thus attract considerable attention globally.

BA/BE studies are a must requirement for any product approvals for domestic and international markets. It needs an in-depth focus on challenges around clinical research, regulatory, study design and many more challenges with real time case study examples.

This two-day workshop will guide on how to design, implement and report Bioavailability and Bioequivalence studies for different formulation types.

Program Focus

Learn & understand the fundamentals of bioavailability, bioequivalence and biowaivers
Determine when a BA/BE study is obligatory
Examine bioanalytical method validation and maintain compliance requirements in USA and EU
Learn to interpret biowaiver regulations in USA and EU and meet compliance
Develop strategies for testing highly variable drugs and design studies for different types of formulation
Assess the regulations in the EU, USA, Russia, Brazil, China and Japan for bioequivalence studies to gain a global perspective and maintain compliance
Evaluating the risk associated with submitting a biowaiver

Benefits of Attending


An opportunity to master BA/BE studies from a globally renowned subject matter expert

Understand how to identify the various BA/BE protocol studies that are used

Gain insights on how to calculate pharmacokinetic parameters on various types of studies and formulations

Achieve clarity on regulations of various countries and their compliances

Cross-learn and network with your peers from different parts of the globe with no geographical limitation at a virtual workshop

Who Should Attend?


Departments

  • Clinical Research
  • Formulations Development
  • Regulatory
  • Pharmacology
  • Project Management (BA/BE)
  • Biostatisticians
  • Bioanalytical
  • Quality Assurance

Gold Partner

Exhibit Partner





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