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Informa
Starting 12 October 2020

4-week online academy

Examine key regulatory and data requirements for the practical application of biowaivers in the EU and US

Course Overview

A biowaiver means that in vivo bioavailability and/or bioequivalence studies may be waived (not considered necessary for approval). As a result, they represent a useful and cost-effective alternative to performing in vivo studies for generic drugs, however, they can be challenging to get right first time.  
 
This course will improve your understanding of various biowaiver types to ensure success in your future applications. Study 8 modules over 4 weeks, using case studies and practical guidance. By examining the requirements for BCS-based, Strength, and IVIVC biowaivers, you will have the confidence and skills to implement a strategic approach for new product registrations. 

Online Academies

Pharmaceutical Training International online courses are on-demand digital courses developed by our expert faculty providing learning on a range of technical topic areas.

Over 4 weeks students will learn through:

  • 8 modules, split up into multiple bitesize recorded videos
  • Quizzes to test your knowledge
  • Revisiting the content with unlimited access to all the materials for 3 months
  • Participating in the discussion forum to interact with other students
  • Interacting with the trainer through the forum during the course
  • Additional content such as materials and white papers available to download

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?


Biopharmacy
Biopharmacy

Introduction to biopharmacy

Legal Framework
Legal Framework

Understand the legal basis for biowaivers

BCS biowaivers
BCS biowaivers

Investigate BCS biowaivers


Strength Biowaivers
Strength Biowaivers

Comprehend strength biowaivers

Dissolution Data
Dissolution Data

Understand dissolution data to be submitted

IVIVC Biowaivers
IVIVC Biowaivers

Consider applications of IVIVC biowaivers


Regulatory Affairs
Regulatory Affairs

Learn about and compare US-FDA and EMA regulations

Who is this course for?

This course is designed for professionals involved in the development/ registration of generic products. Attendees may work in the following areas:

  • Regulatory Affairs
  • Pharmaceutical Development
  • Analytical Development
  • IVIVC
  • R&D for generics

Find out more about online academies...


PTI online academies are perfect for busy professionals as they require just 2 hours per week of your time, and include an interactive forum for you to ask direct questions about challenges you are facing to expert course leaders.

On average, delegates of our online academies said...

4/5
for quality of content
85%
applied content during the course to their role
4/5
for quality of delivery

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.