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Meeting Canadian Regulatory and Inspection Requirements for Temperature Sensitive Products
• Understanding the feedback from recent audits on how to show evidence of compliance: Are you conducting the right validation studies for -20°F?
• Describing stability studies and data that work
• Recognizing how manufacturers can assist the Canadian Provinces when there is a cold chain breach
Harold Rode, Chief, Pandemic Influenza Division, Biologics and Genetic Therapies Directorate, Health Canada
MHRA Regulatory Feedback - Ensuring Your Products Comply With European Temperature Control Regulations From Clinical Materials to Marketed Products
• Comparing MHRA regulations with other European National Agencies – Are U.S. companies on the right track to comply across Europe?
• Gaining a European regulatory view on how industries can gain more control of temperature-sensitive products further downstream in the cold chain
• Clinical materials – What are the Regulators concerns and expectations?
• Describing what information and how much should be included in quality reports and risk assessments
Ian Holloway, Manager, Defective Medicines Report Centre, MHRA
The Final Updated Revisions to General Chapter 1079: Practical Guidance to Updating Your Cold Chain Management
• Explaining recommended control strategies – from warehouse through end-user
• Describing specific protocols for receiving, shipping and storing – when, how and how much
• Following the tables in the updated guidance to make the right choices in your cold chain management
• Understanding the updated SOPs and how to implement them
Dr Mary Foster, USP Packaging and Storage Expert Committee Member, US Pharmacopeia (USP)
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Reducing Toxicity in Drug Compounds
Reduce your failure rate in drug development by effective early stage toxicity modelling, prediction and testing
January 26 - 27, 2009 *
The Grosvenor Victoria, London, UK
Cool Chain Europe 2009
January 27 - 29, 2009 *
Sheraton Brussels Airport Hotel and Conference Centre, Brussels, Belgium
Polymorphism and Crystallisation 2009
Simplify Your Polymorph Screening and Crystal Growth Strategies to Ensure Effective Scale-Up
March 11 - 13, 2009 *
Thistle Marble Arch, London, UK
European Pharmaceutical Contract Manufacturing 2009
March 24 - 25, 2009 *
Venue to be confirmed, London, UK
Compound Management & Integrity 2009
May 18 - 20, 2009 *
Radisson Edwardian Heathrow, London, UK
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Top Events
2nd Enhanced Solubility & Bioavailibility
February 09 - 11, 2009 · Relexa Hotel, Frankfurt/Main, Germany
Industry News
Business Wire | Jan 5 2009 6:04AM
Zacks Bull & Bear of the Day Highlights: Isis Pharmaceuticals, LeapFrog, Johnson & Johnson, Exxon Mobil and iPass
Business Wire | Jan 5 2009 6:04AM
Meda Acquires World-Wide Rights to Onsolis
Business Wire | Jan 5 2009 5:49AM
Research and Markets: Currently Druggable in Colorectal Cancer: A Drug Target Competitive Analysis
BBC Monitoring Central Asia | Jan 4 2009 7:15AM
Iranian Police Seize Over 100 Kg of Drugs in Northwestern Province
BBC Monitoring Asia Pacific | Jan 4 2009 5:45AM
China Made "Obvious Achievements" Fighting Drugs Last Year - Ministry
View All Industry News
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