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Text Content

Home

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Learning Hub


Contact Us


Contact Us
Home
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Events
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Learning Hub





COUNT EVERY SECOND UNTIL THE EVENT

42
Days
21
Hours
50
Minute
49
Second
2023-05-11 8:30



COURSE OVERVIEW

Stability evaluation occurs at various stages during the development of a drug
product. At early development stages, it is used to select formulations and
packaging configurations that are most likely to give a commercially viable
shelf life. At later stages, stability data from formal studies is used to
justify product shelf life (in the primary pack), shipping excursions and
process hold times. This course covers the science behind stability evaluation
as well as regulatory expectations.

Risk-Based Stability Evaluation of Pharmaceuticals Masterclass is a live,
two-days course, which begins with an overview of the types of stability study
conducted (including predictive stability studies), followed by a review of
current regulatory expectations. It is important that forced degradation studies
are predictive of real-time and accelerated conditions, and an approach that
makes this more likely is described, including the use of a humidity-corrected
Arrhenius model (Accelerated Stability Assessment Programme, or ASAP).

Within the ICH regions (Climatic Zones I and II), the Q1 stability guidelines
are followed, but for companies seeking global approval for new drug products,
the requirements for other regions are described. The science behind
photostability evaluation is explained, together with the requirements for data
trending and reduced study designs (bracketing and matrixing). The stability of
biological products (ICH Q5C) is described, together with typical protein
degradation pathways and analytical approaches.



Recently, the IQ Consortium has published a series of papers proposing updates
to current stability guidance. They have recommended a risk-based life cycle
management approach to stability evaluation for chemical drugs and biologics in
line with the principles of Quality by Design (ICH Q8), quality risk management
(ICH Q9) and drug product life cycle management (ICH Q12). The IQ Consortium
approach focuses on understanding the risks to drug product stability and
designing a formulation (including material attributes), manufacturing process
and primary pack that together mitigate those risks.

LEARNING OBJECTIVES

 * A deeper insight into the science behind stability evaluation
 * An appreciation of the use of stability evaluation at each stage of drug
   development
 * An understanding of how to design efficient stability studies that meet the
   requirements of regulatory authorities
 * An understanding of how to design stability studies in line with the
   principles of Quality by Design
 * An insight into designing a risk-based stability study
 * Answers to your questions on stability studies


RECEIVE UPDATES ABOUT EVENTS


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WHY JOIN THE EVENT


KEY TAKEAWAYS OF THE PROGRAM

You want to understand how to design effective and efficient stability studies

You would like to know more about the science behind stability evaluation

You would like to understand how to design stability studies in line with the
principles of Quality by Design

You want to understand the key inputs to stability prediction tools

You want an overview of regulatory requirements relating to stability studies

You would like to get a deeper insight into risk-based stability evaluation

You would like to improve the predictive nature of stress studies

You would like to improve data quality and your approach to result trending


WHO SHOULD ATTEND


AN EVENT PRECISELY FOR YOU

Stability Managers / Staff
Stability Managers / Staff
QA/QC Professionals
QA/QC Professionals
Formulation Development Scientists
Formulation Development Scientists
Analytical Development Scientists
Analytical Development Scientists
Regulatory Affairs Personnel
Regulatory Affairs Personnel
CMO / CRO Scientists
CMO / CRO Scientists


THE SPEAKER


MEET YOUR TRAINER

Dr Mark Powell is a Fellow of the Royal Society of Chemistry (RSC) with over
thirty years’ experience as a senior analytical chemist. Mark has served as both
Honorary Secretary and Honorary Treasurer of the RSC’s AnalyticalDivision and
led a working group on continuing professional development until July 2016.

He has worked at a senior level in several companies with responsibility for
analytical development and equipment qualification. In 2010 Mark was appointed
Scientific Manager of a UK-based pharmaceutical CRO, with responsibility for
guiding the direction of drug development programmes, including stability
evaluation.

In 2013, he set up his own company to provide training and consultancy services
to the pharmaceutical industry. His consultancy work has involved managing the
analytical and stability aspects of early and late-stage pharmaceutical
development programmes and conducting data integrity audits. He is in demand as
a trainer in topics such as pharmaceutical development, chromatography,
spectroscopy, dissolution testing, data integrity, control of impurities,
technical writing, root cause analysis and stability/stress studies.


DR. MARK POWELL

Director
Mark Powell Scientific Limited



THE CURRICULUM


WHAT YOU’LL GET FROM THIS EXCLUSIVE EVENT

FRESH CONTENT

Knowledge is only useful when it is relevant. This event is based on the latest
research, best practices and industry information. As a result, we close events
with a strong knowledge base that helps achieve same-day results.

NETWORKING

Meet and collaborate with like-minded professionals across the globe. Grow your
professional network, exchange ideas, and learn more about the industry with
your own peers, together.

EXPERIENCE

Experience comes with practice, and this event will guide you on the right path
in becoming a well renowned expert in your field. You will learn through a
combination of lecture-based content, real-life case studies, and a more
hands-on experience.


Q&A SESSION

By joining this class, you will be given the opportunity to constantly engage
with your peers and raise your concerns, questions, or doubts you may have
pertaining to the subject. And, receive well-founded, well-thought-out answers
to your every need by leading experts in the industry. 


SIGN UP


GETTING REGISTERED IS EASY!


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KEYNOTIVE

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CONTACT US

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   London, WC2H 9JQ UK

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