- email:registrations@informa-ls.com
- phone:+44(0)20 7017 7481
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1st
Regulatory Affairs for Biopharmaceuticals
16 - 17 November 2010
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Regulatory Affairs for Biopharmaceuticals
The industry’s ONLY conference dedicated to Regulatory Affairs for Biopharmaceuticals
Informa Life Science is proud to announce it's inaugural event on Regulatory Affairs for Biopharmaceuticals; Assessing analytical, technical and quality aspects with regards to the biopharmaceutical regulatory landscape
2010 Conference Highlights
- FDA comparability protocols and EU comparability: read more
Dr Ron Taticek describes Genentech’s experience with the Post-Approval Lifecycle Management (PALM) plan read more
- The regulatory submission of immunogenicity data will be presented read more
- Learn how to successfully prepare for and pass an inspection read more
- Risk assessment, control and review read more
Dr Keith Watson, from Parexel and Former Assessor at the MHRA examines the EU regulatory approval process for biosimilar monoclonal antibodies read more
Expert Speaker Panel
Expert Speaker Panel
Dr Ron Taticek
Director, Pharma Technical Regulatory
Genentech, USA
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Dr Sue Stephens
Senior Director
UCB Celltech, UK
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Tim Tue Wodskou
Regulatory Professional, Regulatory Affairs
Novo Nordisk, Denmark
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Dr Florence Salmon
Regulatory Development
AMT, The Netherlands
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Prof Roy Jefferis
School of Immunity & Infection
University of Birmingham, UK
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Carmen Salazar Ruan
Quality Assurance Manager
Cellerix, Spain
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Dr Michael Tovey
Director of Research,
INSERM, France
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Dr Parastoo Azadi
Complex Carbohydrate Research Centre
University of Georgia, USA
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Media Partners
First-of-a-kind industry event
Avoid critical technical and regulatory mistakes and speed up your product approval
Pre-Conference Workshop: Monday 15th November 2010
Quality/CMC Regulatory Strategy for Biopharmaceuticals – Characterisation, Comparability, Release and Stability Requirements
Workshop Leader: Dr Nadine Ritter, Senior Consultant, Biologic Consulting, USA
Further Speakers Include:
Dr John Roth, Group Director, Metabolic Group, Pharma Development Regulatory, Roche Pharmaceuticals, Bahrain
Stephen Kidner, General Project Manager, Health Protection Agency, UK
Dr Christian Korherr, Manager Regulatory Affairs, Roche Diagnostics, Germany
Dr Cledwyn Davies, Compliance Manager, Health Protection Agency, UK
James Harris, CEO, Healthcare Economics LLC, USA
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Dates and Venues
16 Nov 2010 - 17 Nov 2010
Maritim proArte Hotel
