GenoToxic Impurities
Danubius Hotel
Regents Park,18 Lodge Road, St.John's Wood
London, UK
Keywords: Informa Life Sciences, Danubius Hotel, GenoToxic Impurities

Schedule of Presentations:

Tuesday, June 16, 2009
07:25:00 Check-In
08:30:00 Registration
09:00:00 Opening remarks by the Chairperson
09:10:00 CHMP guideline: Regulatory overview on issues and challenges Henrik Tang Vestergaard
09:50:00 FDA genotoxic guidance for industry: Comparison with the CHMP guidance Tim McGovern
10:40:00 Morning coffee and networking
11:10:00 Industry perspective on the CHMP guideline (Q&A supplements), FDA guideline and the EDQM position paper Sabina Jurca
11:50:00 Practical application of the CHMP guideline to marketed products Andrew Teasdale
12:30:00 Spotlight session
13:00:00 Lunch
14:10:00 Managing genotoxic impurities in a small to mid-sized company Dirk Schwartz
14:50:00 Generic development in line with the CHMP guideline Henny Hofs
15:30:00 Insight into a regulatory toxicological assessment Elisabeth Klenke
16:10:00 Afternoon refreshments and networking
16:20:00 Risk assessment and control of genotoxic impurities in treatments for life-threatening diseases Charles Humfrey
17:20:00 Sulphonate Esters – How real is the risk? Key findings from studies into the reaction between Sulphonic acids and Alcohols Andrew Teasdale
18:00:00 Closing remarks by the Chairperson and end of Day 1
18:05:00 Announcements
Wednesday, June 17, 2009
08:30:00 Check-In
09:00:00 Opening remarks by the Chairperson
09:10:00 Building genetic toxicology into preclinical development strategies Susanne Glowienke
09:50:00 Mutagenicity testing for starting materials and intermediates Dr. Jacques Van Gompel
10:30:00 Morning coffee and networking
11:00:00 Summing up impurities: when does it apply? Roland Frötschl
11:40:00 Experiences of development, validation and routine use of a GRI analytical method in production environment Dave Elder
12:20:00 Lunch
14:10:00 Solvay’s current approach in PGI assessment Tom van Wijk
14:50:00 Afternoon refreshments and networking
15:20:00 Linking forced degradation to genotoxic impurities Alan McKeown
16:00:00 Defining level of acceptability for genotoxic metabolites Esther Vock
16:10:00 Designing and implementing analytical control strategies for PGI’s Remco Stol
16:40:00 Discussion on issues arising from the day
17:00:00 Closing remarks by the Chairperson and end of Day 2
3D Tissue Models
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