International

TRAINING COURSE

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Advanced
IVIVC
www.fleming.events

Professional
19 & 20 September 2022, Vienna, Austria
9:00 CEST – 17:15 CEST
Now also available via
Online live stream!
 All sessions of this unique course online
 Live interaction options between the delegates and trainer
 Available via mobile, tablet or laptop
In the light of the current outbreak of COVID 19 across Europe, we have prepared
an option to accommodate those delegates who will not be allowed to travel. The
situation might fully be under control by the time when the training is planned to run,
however we want to make sure everyone will get the same chance to take part in this unique training course.
Are you going to be able to attend the course in-person? Fantastic! We are looking forward to meeting you.
Will you not be allowed to travel or do you feel it is safer to enjoy this unique course from the luxury of your
office or home via your laptop, tablet or mobile? We obviously understand the situation and offer you the
opportunity to join us via the online live stream enabling the mutual interaction between you and the trainer.

Online Live Training Features:

 Real-time, instructor-led course
 Live discussions
 Chat with participants
 Gallery view to see all participants in video
meeting in at one time
 Comprehensive digital course documentation
 Case studies from the trainer's experience
 Certificate of completion issued by the trainer

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www.fleming.events email: [email protected]
ONLINE
Key Takeaways:
Get
Key topics:
 Introduction to IVIVC
critical insights into the types of IVIVC  Establishing IVIVC in theory
 Common problems and errors when
Understand establishing IVIVC

 the selection of most appropriate data to

establish IVIVC
 Absorption determination
 Time scaling
 How to predict concentrations
Familiarize  Specific cases 1
yourself with predictability  Specific cases 2
 Utilization of IVIVC
Learn  Legal frame
when IVIVC could & could not be established

Gain
clarification on intersubject & intrasubject
Face to Face
variability
Training Features
Explore  Real-time, instructor-led course
absorption determination  Live discussions
 Open discussions between breaks
 Comprehensive course documentation
Understand
 what to do in absence of Unit Impulse
response: IR or IV


Case studies from the trainer's experience
Certificate of completion issued by the
trainer

Learn
how to establish time scaling, classical and
inverse of release function
Training audience
Two stage This Training Course is of particular interest to:
approach level A and Level C approach, examples  IVIVC specialists
on applications for MR formulations, class 2  Biowaiver & Biopharmaceutical scientists
drugs, metabolites, etc…  BA/BE managers
 Pharmacokineticists
Alternative approach  Biostatitics and data modeling specialist
 Regulatory affairs professionals
convolution through deconvolution methods,
 Dissolution testing specialists
example on Long-acting implants
 Formulation specialists and managers
Specific case,
discuss ways to apply IVIVC for DR formulations,
Inhaled products
Create your own In-House
Gain Training
tips for pooling data from more than one study Are you looking for something more specific?
Create your own In-House Training customized
to the specific issues your company and your
Explore employees need to understand and resolve. Save
setting dissolution limits time and cost while increasing implementation
with an In-House Training held in the privacy of
your company.
Understand
 utilization of IVIVC in development, variations,
optimization
Read more about In-House
Training opportunities
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ONLINE
Meet the Training Leader:
Jean-Michel Cardot
Consultant SAS Borvo
Professor
J-M. Cardot, Pharm D, Ph. D. is consultant for SAS Borvo located in France.
He was Professor and head of the Department of Biopharmaceutics and Pharmaceutical Technology from the
Auvergne University, France from 2002 to 2021. From 1987 to 1999 he was in Ciba-Geigy and Novartis in development
departments in Basel and in Paris. He created in 1999 a company dedicated to the production of technical and clinical
batches of high potent activity drugs. From 1992 to 2002 J-M. Cardot was also associated professor in Auvergne
University in Biopharmaceutics.
J-M. Cardot is pharmacist (D Pharm), he got Masters in Biopharmaceutical, Statistical sciences and Pharmacokinetics
and has a Ph. D. in pharmaceutical sciences Auvergne University.
His research fields are Biopharmaceutical development of drugs, in vitro dissolution and in vivo bioequivalence and in
vitro-in vivo correlation

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 Day 1
19th September 2022

8:45 Registration & welcome coffee/Login

coffee of remote 13:45 Absorption determination
participants to join the online live stream • Compartment-based methods
• What is a deconvolution?
9:00 Welcome note from Fleming & opening remarks • Model-based methods
from the trainer • Model-independent methods
• Flip-Flop problems
9:10 Introduction & speed networking • What to do in absence of IR or IV
Join with your camera turned on to meet & greet
the trainer and participants, as well as to share Q&A
your expectations on this course and what you
would like to learn 14:45 Break
9:30 Introduction to IVIVC
15:00 Dissolution data
• Description of the IVIVC backgrounds
• Quality of dissolution data
• Selection of most appropriate data to establish
• How to use dissolution data
IVIVC
• Modeling of dissolution data
• Types/levels of IVIVC: A to C
• Data needed in vitro 16:00 Time scaling
• data needed in vivo
• Time scaling concept
Q&A • How to establish time scaling
• Non-linear time scaling
10:30 Break • Time scaling in place of IVIVC

11:00 Establishing IVIVC in theory Q&A

• How to establish IVIVC in theory
17:15 End of Day 1
• Predictability
• When IVIVC could be established
• When IVIVC could not be established

Q&A

12:00 Luncheon

13:00 Common problems and errors when

establishing IVIVC
• Intersubject variability
• Intrasubject variability
• Limit of formulation change

Q&A

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ONLINE
 Day 2
20th September 2022

8:45 Registration & welcome coffee/Login

coffee of remote 14:10 Specific cases 4
participants to join the online live stream • Pooling data from more than one study
• Utilization in development, set up of optimal
9:00 How to predict concentrations dissolution profile and use of DOE
• Compartmental based method • Setting dissolution limits: classical approach
• Convolution • Setting dissolution limits: approach including in
• Predictability vivo variability

Q&A Q&A

10:00 Specific cases 1 Oral formulations 15:10 Break

• Level A IVIVC
- Classical Application for MR formulations 15:40 Legal frame
- Classical Application for DR formulations • Comparison of EMA, FDA requirements
- Application for class 2 drugs • IVIVC in scope of ICH Q8 and Q12

Q&A Q&A

10:50 Break 16:10 EXTENSIVE Q&A

11:10 Specific cases 2 17:00 Wrap-up & close-up

• Level C IVIVC
17:15 End of the Training
- Application to Metabolites
- Application to reduced set of data

Q&A

12:10 Lunch

13:10 Specific cases 3

• Averaging
• Generic use of originator or published data: how to
use it internally
• Long Injectable formulations Convolution through
deconvolution
• Orally Inhaled products

Q&A

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ONLINE
Do you need a different topic,
venue or date?
Create your own
custom-made training.

In-House Training
Specific industries face specific problems. We find a trainer, draft topics, and then
They require niche information and find the premises and dates which match
solutions. In-House Training is precisely your needs.
tailor-made to your needs.

Taking place in the privacy of your Provide your employees a unique learning
company, including real-life case studies experience without having to leave
and best practices, the course is led by the office.
an independent industry expert.

"Knowledge is important,
but implementation is crucial."

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Get More
InforMatIon
The team behind:
We are delighted to bring you the
Advanced IVIVC Professional
Click on the ticket below to sign up

Or write to
[email protected]
to get in touch with a member of
our team

Dasa Janosikova
Production Manager - Life Sciences

Monica Jones
Marketing manager

Vienna
The iconic French croissant originates from Vienna.
These buttery and soft delights are based on an Austrian
pastry called Kipferl (meaning ‘crescent’ in German).
They were made by Viennese bakers to commemorate
the Austrian victory over the Ottoman Turks in 1683.
The shape of the pastry was based on the crescents
that adorned the uniforms of their enemy. When Marie
Antoinette married King Louis XVI, she introduced her
favorite pastry to France, few changes were made, and
the croissant was introduced to the world.

Now also available via Online live stream!

 All sessions of this unique course online
 Live interaction options between the delegates and trainer
 Available via mobile, tablet or laptop

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