Invitation from the Organiser

Once again, the aim of this event is to provide a platform for interesting and interactive discussions with:

• regulatory authority representatives (EMA and FDA)

• industry experts

• university colleagues

mutually committed to meet society’s and regulator’s growing expectations of the industry.

This year’s the programme will again focus on the pivotal role PAT plays in delivering the levels of process understanding and process control to underpin Quality by Design. It will also include a range of processing considerations proving increasingly important to ensure that Good Manufacturing Practice is actually more capable of delivering Good Manufacturing PERFORMANCE consistently.

The workshop content will provide all delegates with highly interactive settings where experts from the pharmaceutical industry, regulatory authorities and international academia will share their experiences in the following areas:

• Process Understanding - Facilitating the Transition from Process Validation to Continuous Verification

• How Material Science can help bridge the gap between API and Drug Product Manufacture

• What’s driving the transition from Batch to Continuous Processing

• Performance-Based Quality Specifications - Establishing a Science-Based Target for Pharmaceutical Manufacturing

These developments are equally applicable to new, legacy and generic product development and manufacture and pivotal to achieving the significant step change in industry performance being sought, as is the content of the complementary series of case studies in the lecture programme.

It would be a great pleasure for me to welcome you in Heidelberg on behalf of the Institute of Pharmacy and Molecular Biotechnology.