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.
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
- 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
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PTI - Pharmaceutical Training International - Training for the Pharma Industry
PTI is the global leader in professional education for the pharmaceutical industry, delivering a broad course portfolio that covers the industry spectrum: R&D, Clinical Development, Generics, Bio-pharmaceuticals, fine Chemicals, Agro-chemicals, Medical Devices, Animal Health, Manufacturing and Regulations. PTI's open courses,...
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