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Biowaivers: Practical And Regulatory Approaches - Online Academy

PTI
Course summary
4 weeks
800 GBP
Online courses
Professional Training

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. 

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

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About provider

PTI - Pharmaceutical Training International

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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Contact info

PTI

London

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http://www.pti-global.co.uk


Reviews

Average rating 5

Based on 3 reviews

Regulatory Affairs International Project Manager, Medac GmbH
(5)
The trainer was very experienced with many examples and encouraged time for questions.
Director, Northumbria Pharma
(5)
The trainer was very knowledgeable and had good presentation skills.
Regulatory Affairs Development Manager, Regivet BV
(5)
The knowledge of the trainer was excellent. There were a lot of practical examples given including issues which I had encountered in the past.
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