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02-03-2020 (Online Course)

P40113D Strategies for Developing IVIVC Studies
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Strategies for Developing IVIVC Studies

4-week online course starting 2 March 2020

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overview

In-vitro in-vivo correlation is a critical tool described in many guidelines and its usage in development is recommended to reduce the risk of in-vivo testing. Led by Jean-Michel Cardot, of Auvergne University, this 8-module course will allow you to consider the many implementation issues of IVIVC. Packed with examples and explanations, the course will build towards a comprehensive understanding of IVIVC, its limitations, data requirements and more.

 

Key Benefits of Attending

  • Gain a comprehensive introduction to the IVIVC
  • Familiarise yourself with the full scope of the data requirements and activities of IVIVC
  • Discover how to establish an IVIVC
  • Determine scaling factors and how to successfully use them to develop an IVIVC
  • Calculate an effective IVIVC strategy to avoid pitfalls
  • Build on your knowledge of the legal and regulatory framework of IVIVC

Who Should Attend

This course is aimed at professionals with experience knowledge in drug development areas such as formulation, quality and dissolution testing and who want to learn more about the techniques and calculations involved in In Vitro In Vivo correlation. It will be beneficial to personnel working with generics and in the following areas:

  • Scientific Research
  • Analytical Development
  • Formulation
  • Early Development
  • Regulatory Affairs
  • Quality Assurance
  • Quality Control

 

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 IVIVC in development

  • Definition of IVIVC
  • Discover when IVIVC can be established
  • Learn when IVIVC should not be established
  • Gain an awareness of the limitations of IVIVC

Module 2:
Introduction to IVIVC

  • Exploring in vitro dissolution methods
  • Examining in vivo methods used for IVIVC
  • Absorption
  • Determination
  • Selection of the most appropriate data to establish IVIVC

Module 3:
Data needed for IVIVC

  • Discover how to establish IVIVC
  • Level A
  • Level C
  • Examining predictability

Module 4:
How to establish IVIVC

  • What is time scaling?
  • Determination of scaling factor
  • Learn how to use time scaling

Module 5:
Time scaling

  • Overview of common pitfalls when establishing IVIVC
  • Examples of ineffective IVIVC strategies
  • Best practices to avoid these pitfalls

Module 6:
Overcoming the pitfalls of IVIVC

  • Determination of dissolution limits
  • Various examples

Module 7:
Dissolution limits

Module 8:
Understanding the legal framework of IVIVC

  • Gain an insight into the requirements of IVIVC in:
  • Development
  • Quality Control
  • Biowaivers

when & where

02 - 31 Mar 2020

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

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