- email:registrations@informa-ls.com
- phone:+44(0)20 7017 7481
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Regulatory Affairs for Biopharmaceuticals
22 - 23 November 2011
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Regulatory Affairs for Biopharmaceuticals 2011
The industry’s ONLY conference dedicated to Regulatory Affairs for Biopharmaceuticals
Designed specifically to address the developments and challenges in the biopharmaceutical industry; Informa Life Sciences’ Regulatory Affairs for Biopharmaceuticals conference is dedicated to those professionals from regulatory affairs teams as well as those wanting to understand regulatory approval pathway for biopharmaceutical products.
2011 Conference Highlights
- Hear unprecedented insights from 4 Regulatory authority representatives... read more
- US Biosimilar Statute and FDA updates: read more
- Global update from ISPE PAT CoP steering committee on QbD: read more
- Essential EMA guidance updates... read more
- Discover regulatory and industry insights into biosimilar development: read more
- New interactive evening surgery and pre-conference workshop! read more
Best practices and essential strategies for success with post-approval change management read more
Expert Speaker Panel
Expert Speaker Panel
Cecil Nick
Vice President (Technical)
PAREXEL
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Dr Michael Jarsch
Director, Biologics Research, Pharma Research and Early Development (pRED)
Roche
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Robin Thorpe
Head, Biotherapeutics
NIBSC
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Dr Fiona Greer
Director, Biochemical Services
M-Scan
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New speaker!
Cecil Nick, VP (Technical) of PARAXEL Consulting has joined the speaker faculty.
Media Partners
Sponsors
CPD Certification
New speaker!
Dr Michael Jarsch, Director of Biologics Research, Pharma Research and Early Development (pRED) at Roche joins the agenda.
Pre-Conference Workshop: Monday 21st November 2011
Regulatory affairs for biopharmaceuticals in Emerging Markets
Countries to be evaluated in comparison to the EU include: Brazil, Russia, India, China & Turkey
Workshop Leaders:
Alan Chalmers, Director, Pharma International, Switzerland
Seda Kadioglu, Seda Kadioglu Consulting, Turkey
Sylvie Duclaux, Director of Transverse Projects, Global Regulatory Affairs Conformance, Sanofi Aventis, France (Awaiting final confirmation)
Evening Seminar: Tuesday 22 November 2011
Regulatory Evening Surgery
Regulatory Authority Q&A and panel discussion sessio
Dr Bettina Klug, Paul-Ehrlich-Institut, Germany
Dr Steinar Madsen, Norwegian Medicines Agency, Norway
Thomas Lang, AGES PharmMed (Member of the EMA’s Scientific Advice Working Party and Biostatistics Working Party
Dr Pekka Kurki, Finnish Medicines Agency, Finland
Dr Robin Thorpe, National Institute for Biological Standards and Control, UK
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Dates and Venues
22 Nov 2011 - 23 Nov 2011
Andel's Hotel Berlin
