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03-02-2020 (Online Course)

P40111D Biowaivers: Practical and Regulatory Approaches
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Biowaivers: Practical and Regulatory Approaches

4-week online course starting 3 February 2020

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overview

Biowaivers represent a useful alternative to performing in-vivo studies for generic drugs.

This course will help 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.

Key Benefits of Attending

  • Introduction to biopharmacy
  • Understand the legal basis for biowaivers
  • Investigate BCS biowaivers
  • Explore strength biowaivers
  • Understand dissolution data to be submitted
  • Consider applications of IVIVC biowaivers
  • Learn about and compare US-FDA and EMA regulations

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

Course Duration

  • 4 weeks
  • 2 hours per week (average)

Virtual Learning

Click here: https://youtu.be/03tV6fxmyMs

pricing

Packages Price
Online AcademySGD $1000Early Bird
  • Fee stated is the discounted price PER DELEGATE.
  • A 7% Goods & Services Tax (GST) is applicable to all Singapore based companies for Singapore venue.
  • View payment terms and bank transfer details, click here »

Trainer's Profile

Professor Jean-Michel Cardot
Head of Biopharmaceutics an d Pharmaceutical Technology
at the Universite d’Auver gne in France.

Jean-Michel Cardot is professor and Head of the Department of Biopharmaceutics and Pharmaceutical Technology at the Universite d’Auvergne, France. The research fields of his laboratory are dissolution, bioequivalence and IVIVC. His personal research fields are biopharmaceutical development of drugs, in vivo bioequivalence and in-vitro in-vivo correlation

Why Attend An Online Academy?

Online Academy is an excellent forum to correspond with the teacher/instructor and your fellow students within the course while saving time, cost while maximising the effectiveness of bitesize chunks-learning and regular revisions

  • Grow as a team – with multiple licenses your team can access the course and learn together, no matter where they are in the world
  • Review all content as many times within enrolment period (two month after all modules have been released)
  • Time effective – bitesize chunks so it does not impact on your normal working day
  • Progress through the course with fellow students as you would in a classroom
  • Discuss the course with fellow students
  • Cost effective – no travel expenses

About BioProcess International Academy

BioProcess International Academy is a partnership between BioProcess International (BPI) and Pharmaceutical Training International (PTI). Our vision is to accelerate the growth of the biopharmaceutical sector by providing training solutions which are designed to enhance the technical skills, knowledge and competencies of biotech professionals. The Academy’s extensive course portfolio is determined by the latest industry trends and created by our global network of leading experts and delivered via workshops, digital academies and customised onsite programs.

BioProcess International Academy’s vision is to accelerate the growth of the biopharmaceutical sector by providing training solutions which are designed to enhance the technical skills, knowledge and competencies of biotech professionals. The Academy’s extensive course portfolio is determined by the latest industry trends and created by our global network of leading experts and delivered via workshops, digital academies and customised onsite programs.


Upon completion of your BioProcess International Academy online course you will be awarded with the CPD Certification certificate. This is a recognised independent CPD accreditation compatible with global CPD principles.

The Certificate of Achievement provides proof that you have taken the course and can be used on your CV or work portfolio.

 

 

FAQ

Do sessions go out live?
No, all content is recorded and a set number of modules are released per week. You have unlimited access to module content once it has been released for the duration of the course and an additional two months.

Can I join after the course start date?
Yes, because modules are not live and all content is recorded you can catch up. Please contact us at register@informa.com to enquire about joining a course after the start date.

Can I still take part if I’m away for part of the course run?
Yes. Online Academies provide a flexible learning format. As modules are not released live and are available for review, you will be able to catch up.

How long is my enrolment on the course?
You are enrolled on the course for the period that modules are being released and the trainer is active on the discussion forum (this varies from course to course – between 3 – 8 weeks) and for an additional 2 months after this to review course content.

Who do I contact if I have any problems while the course is running?
You should contact BPI-online@informa.com

When will I receive my log-on details for the course?
Once you have paid, a member of the team will be in touch with your log-in details. We must receive payment for you to access the course.

How can I access the content?
Content is hosted on our Learning Management System, which you access using your device. A link will be provided to you with your log-in details.

What if I need extra time on the course?
Please contact us at register@informa.com if you would like extra time on your course beyond the enrolment period. Extra time is subject to approvals and fees may apply.

Agenda

Module 1: Introduction to biowaivers

  • Introduction to biopharmacy
  • Introduction to bioequivalence
  • What is a biowaiver?
  • What is the legal basis for biowaivers?

Module 2: Evidence based biowaivers

  • Oral formulation
  • Injectable formulations
  • Locally applied and locally acting drugs: topical formulation, nasal spray, ocular formulations, cases of drug acting in the GI tract

Module 3: BCS based biowaiver

  • Basis of BCS based biowaivers
  • Solubility determination
  • Permeability determination
  • Formulation prerequisites
  • Application to drugs
  • How to submit data

Module 4: BCS based biowaiver, continued

  • Comparison of US-FDA and EMA
  • Case studies

Module 5: Strength biowaivers

  • Basis of strength biowaivers
  • Formulation prerequisites
  • Application to drugs
  • How to submit data

Module 6: Strength biowaivers, continued

  • Comparison of US-FDA and EMA
  • Case studies

Module 7: Dissolution to be submitted

  • Analysis of dissolution data

Module 8: IVIVC biowaivers

  • Basis of IVIVC biowaivers
  • Application to drugs
  • Comparison of US-FDA and EMA
  • Case studies

when & where

03 Feb - 03 Mar 2020

Access the Online Course : https://vle.knect365.com

On-site & in-house training

Deliver this course how you want, where you want, when you want – and save up to 40%! 8+ employees seeking training on the same topic?

Talk to us about an on-site/in-house & customised solution.

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