- email:registrations@informa-ls.com
- phone:+44(0)20 7017 7481
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4th Annual
Setting Specifications
28 - 29 November 2012
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Setting Specifications
Setting Specifications 2012 - New and updated content not to be missed!
A completely revised and updated agenda bringing you critical regulatory updates and real-life industry case studies demonstrating the latest developments in analytical practices for setting specifications. With new topics including updates on the ICHQ6A guideline; the evolution of the metals guideline; and a reflection paper on liposomes and micelles; Setting Specifications 2012 is not to be missed. Read on for more detailed information on this key manufacturing event.
Hot topics to be covered include:
Watch this space for the latest announcements...
To request more information on how to participate as a speaker at this year's event contact:
Camilla Perselli camilla.perselli@informa.com
Europe's most established event of it's kind!
28-29 November 2012 | Radisson Blu Hotel | Berlin
Speaker Panel
Speaker Panel
Dr George Okafo
Science Director
Scinovo GSK
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Steven Brown
Technical Support Director
Actavis
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Massimo Bresciani
Director of Scientific Operations
Research Centre Pharmaceutical Engineering GmbH
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Dr Christine Weber
Head of Department, Analytical Development
Lundbeck, Denmark
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Larry Wigman, Senior Scientific Manager, Genentech Research and Early Development, USA
Dino Farina, CEO and Founder, Proveris Scientific Corporation, USA
Jackson Pellett, Analytical Chemist, Genentech Research and Early Development, USA
Dinesh Nambiar, Manager Global QA Product Development and Clinical QA, Sandoz International GmbH, Germany
Dawn Toronto, CMC Regulatory Affairs and Analytical Consultant, Germany
Event Buzz Words
- Analytical Practices
- Impurities
- Genotoxic
- Risk-based approach
- Oligonucleotides
- Stability Testing
- Quality by Design
- Specifications
- RTR
- API
Media Partners
Ten reasons to attend:
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Receive direct regulatory feedback from Abigail Moran (MHRA)
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Let Genentech guide you through dissolution method development for poorly soluble compounds
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Get practical advice on analytical practices and how to set specifications for API genotoxic impurities
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Hear the small pharma perspective for setting specifications for impurities
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Keep up-to-date with the latest advice on how to set specifications for oligonucleotides
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Participate in our interactive expert panel session for defining critical quality attributes (CQAs)
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Benchmark your company's progess in applying Quality by Design and RTR for specification setting
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Analyse industry's gradual movement towards risk-based specification setting
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Implement effective analytical practices for setting specifications for inhalation products and nasal products
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Assess practical developments in setting specifications for topical products
Don't miss out on your opportunity to participate in our interactive sessions
Pre-Conference Workshop – Tuesday 27th November 2012
Conducting global stability testing studies to set shelf-life specification
Led by:
Manuel Zahn, Founder and Managing Director, 3R Pharma Consulting, Germany
Evening Seminar – Wednesday 28th November 2012
Implementing risk-based control strategies for setting specifications
Led by:
David Elder, Pre-Clinical Director, SCINOVO, GlaxoSmithKline, UK
Mustafa A. Zaman, Senior Consultant, PAREXEL Internatonal Consulting, UK
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