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