TOPRA's One-Day Biotech Meeting

Understanding Your Biotech Product-Analytical and Bio-analytical Characterization

Dates:
Wednesday
28th January 2009

Venue:
Radisson SAS
Portman Hotel
London, UK

Aims of the course
To ensure that delegates have the appropriate knowledge in the field of analytical and bioanalytical characterization to allow them to undertake their professional roles and specifically as follows:

• The techniques used to characterize biopharmaceutical medicinal products
• Regulatory requirements and expectations for characterisation data at different stages of the product development cycle
• Impact of process variables on product quality
• Requirements for comparability assessment following process changes
• Importance of characterisation techniques in a biosimilar product MAA.

Who should attend
The conference is designed for regulatory staff who are working with biotechnology-derived products, particularly those who may not have first hand manufacturing or process development experience, and those who are new to regulatory affairs. This conference would also be useful for anyone wishing to refresh his or her knowledge in the area.

Programme includes:

• Analytical characterisation concentrating on in vitro and biophysical techniques
• Bio-analytical techniques concentrating on bioassays and agency expectations for bioassays
• Impact of process variables on product quality
• Comparability assessment example following a major process change (a case study from Wyeth)
• Regulatory Agency perspective on comparability
• Biosimilars

Speakers include:
• Paul Chamberlain, Director, NDA Advisory Board, UK
• Brendan Fish, Director Bio-analytical Group, MedImmune, UK
• Brian Fitzpatrick, Associate Director of Analytical Development, Wyeth, Eire
• Stephen Fitzpatrick, Head of CMC RA, UCB Pharma Ltd, UK
• Kowid Ho, Biologicals/Biotechnology Unit, AFSSaPS, France
• Paul Jeffreys, Senior Manager RA, Eisai, UK
• Meg Leahey, Associate director, Wyeth Biotech, Eire
• Cecil Nick, Vice President, Parexel Consulting , UK
• Jane Robinson, NIBSC, UK