Course description
Biowaivers: Practical And Regulatory Approaches - Online Academy
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.
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Suitability - Who should attend?
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
Training Course Content
- 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
Why choose PTI
On average, delegates of their online academies said:
Quality of content:
4/5
85% had applied content during the course to their role
Delivery rating:
4/5
Reviews
Average rating 5
The trainer was very knowledgeable and had good presentation skills.
The knowledge of the trainer was excellent. There were a lot of practical examples given including issues which I had encountered in the past.
The trainer was very experienced with many examples and encouraged time for questions.