Workshop Quality by Design

Start:
10 November 2010
Location:
Naturalis, Darwinweg 2, 2333 CR Leiden
Contact:
Events TI Pharma

Speeding up the process of (bio)pharmaceutical development and manufacturing

Topic
Our changing business environment urges for new (bio)pharmaceutical product marketing strategies. The input of life sciences derived innovations direct towards personalized medicines. With these aspects combined, quality by design (QbD) and its clinical counterpart translational medicine research (TMR) present a new era of (bio)pharmaceutical industry. This speeds up the development of medicines by two times and results in continuous improvement of licensed medicines which will be better suited for patients.

About
During the workshop three successful examples of the application QbB and TMR will be presented. Also, the consequences of the licensing documentation for new products will be discussed. The A-Mab Case Study in Bioprocess Development will be presented by Kenneth Seamon (University of Cambridge). This case study is written by the CMC Biotech Working Group, which describes the impact of QbD for the development of a new therapeutic monoclonal antibody (Mab). At the end of the day, there will be interactive roundtable discussions with the speakers . More information can be found on the website of TI Pharma.

Registration
Registration is free of charge. For registration click here.

If you have any questions, please do not hesitate to contact us.