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.
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 email@example.com.
What will you learn?
Introduction to biopharmacy
Understand the legal basis for biowaivers
Investigate BCS biowaivers
Comprehend strength biowaivers
Understand dissolution data to be submitted
Consider applications of IVIVC biowaivers
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
- 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...
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.