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19-21 SEPTEMBER 2017 //

MARITIM PROARTE HOTEL, BERLIN

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9.00am-5.30pm

A range of deep-dive ½-day Training sessions on the following topics:

Product characterisation/Quality by Design

Quality by Design (QbD) is a science- and risk-based approach to pharmaceutical 
development. Applied to manufacturing processes, it is intended to ensure a rational and cost-
effective approach to product quality.  Both the EMA and FDA have systematically assessed 
QbD elements of regulatory filings and, especially since the FDA’s 2011 Process Validation 
Guidance and the ICH’s Q8 through Q11, it has become an intrinsic part of regulatory guidance.

However, understanding and adoption of the principles of QbD has remained relatively limited 
in the field of cell and gene therapy.  We strongly believe that its methodologies are critical to 
the successful development of ATMPs and that they should be incorporated as early as possible 
into the science of manufacturing.  This workshop will both demystify the fundamentals of QbD 
and provide concrete examples of its application to this field.  You will leave with a crystal-clear 
understanding of P Diagrams, RAMM matrices, the QTPP and many more tools which you can 
immediately use to improve your products and processes.
 

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OR

Clinical trial design for ATMPs

The considerations when initiating a clinical trial for cell-based therapies are diverse and 
numerous. Alternative approaches to traditional clinical development based on sequential, 
seamless design are justified, including exploratory (phase I/IIa) trials examining both safety and 
efficacy while using an extensive biomarker portfolio, whenever applicable. Great emphasis 
should nevertheless be placed on patient safety, particularly in designing appropriate GMP-
grade product and risk-benefit related stopping criteria. In this session some of these aspects 
will be discussed using real-life examples. 

In this session, Professor Dr Abou-El Anein will be joined by his colleague, Mr Daniel Kaiser 
who will discuss the characteristics of a clinical grade product to be used in clinical trials. 
 

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THEN

Authoring the Common Technical Document (CTD) Module 3 (CMC/Quality)

The ICH Common Technical Document was developed to standardise the way information is 
shared with regulators, and is accepted or mandatory by agencies following ICH (e.g. EU, US, 
Japan, Canada etc).  The CTD is used for all types of medicinal product but the purpose of each 
section may not always be clear for ATMP. This workshop aims to clarify:

 

   What the purpose of each section is
   Whether the section is descriptive or data-driven
   What sorts of data are expected
   Tips and considerations for style, use of figures and tables, etc.

 

 

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Followed by an interactive site visit to the GMP facility at the

Charité Hospital in Berlin

 which is open to all attendees

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Advisory Board

"It was a very interesting event as all participants, including speakers were ready to exchange, even on the most challenging subjects such as reimbursement, GMP guidance."

Bertrand Alexandre, Director, Marketing Europe, Celyad

Sponsors

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