Invitation from the Organiser
Dear Madam, dear Sir,
After four successful PAT Conferences from 2005 to 2008, we would
like to invite you to participate in
The University of Heidelberg 2009
International QbD / PAT Conference
Once again, the aim of this event is to provide a platform for
interesting and interactive discussions with regulatory authority
representatives (EMEA and FDA), industry experts and university
colleagues committed to meet the growing expectations of regulators,
industry, and society.
This year the programme will focus on the implementation of Quality by
Design (QbD) concepts and how PAT can help to achieve these new goals in
the context of today's industrial and regulatory challenges.
Developments and initiatives pivotal to achieving a significant step
change in industry's performance will be reviewed. A significant
workshop content will provide all delegates with a highly interactive
setting where experts from the pharmaceutical industry, regulatory
authorities and international academia will share their experiences
with:
- The evolution and interactivity of FDA guidances and
expectations
- Application of PAT/QbD to both legacy and new products
- Opportunities for facilitating a significantly improved
continuum between R&D and manufacture
- Approaches to ensure that product specifications more
realistically reflect therapeutic performance and vice versa
This will be complimented by a lecture programme on specific,
relevant applications.
It would be a great pleasure for me to welcome you in Heidelberg on
behalf of the Institute of Pharmacy and Molecular Biotechnology.
Dr Gabriele Reich
IPMB, University of Heidelberg
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