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Oct 23
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08:00 - 09:00 60 mins
09:00 - 09:10 10 mins
Genotoxic Impurities
Chairperson's Opening Remarks
  • Jared Fennell - Principal Research Scientist, SMDD, Portfolio Design and Integration, Eli Lilly and Company, USA
09:10 - 09:45 35 mins
Genotoxic Impurities
Regulator perspective on interpreting the ICH M7: What regulators want to see
  • Ian Waterson - Non-Clinical Assessor, MHRA, UK
  • Strategies for best practice regulatory submissions according to the ICH M7
  • The latest regulatory mindset for control of genotoxic impurities
  • Updates on the timelines and progress of any updates planned for the ICH M7
  • What is mandatory to demonstrate to ensure compliance
09:45 - 10:20 35 mins
Genotoxic Impurities
Recent developments and issues associated with Mutagenic impurities
  • Andrew Teasdale - Principal Scientist, Chair of Impurity Advisory Group, AstraZeneca, UK
  • The M7 addendum and its future development
  • Relationship of M7 to Q3A / B areas of overlap and uncertainty
  • Advances in in silico tools 
    • QSAR tools
    • Mirabilis 
  •  Recent Valsartan incident – its route cause and impact 
10:20 - 10:55 35 mins
Genotoxic Impurities
ICH M7 Panel discussion
  • Ian Waterson - Non-Clinical Assessor, MHRA, UK
  • Shaimaa Ahmadeen - Senior Drug Assessor, Saudi Food & Drug Authority
  • Masamitsu Honma - Director of the Division of Genetics and Mutagenesis, National Institute of Health Sciences, Japan
  • When do genotoxic impurity assessments have to be repeated for marketed products?
  • Retrospective look at the ICH M7: are analytical methods now less stringent?
  • Is there value for developing methods that are more sensitive rather than fit for purpose?
  • How to test for impurities that cannot be isolated?
10:55 - 11:25 30 mins
Morning Coffee
11:25 - 12:00 35 mins
Genotoxic Impurities
Japanese NIHS perspectives on the control of genotoxic impurities
  • Masamitsu Honma - Director of the Division of Genetics and Mutagenesis, National Institute of Health Sciences, Japan
12:00 - 12:35 35 mins
Genotoxic Impurities
SFDA perspectives on the control of genotoxic impurities
  • Shaimaa Ahmadeen - Senior Drug Assessor, Saudi Food & Drug Authority
12:35 - 13:10 35 mins
Genotoxic Impurities
Genotoxic and General Toxicological Evaluation Approach of impurities: A Case Study from New Approved Medicinal Product
  • Jorge Gonzalez Borroto, Ph.D. - Pharmacovigilance Officer / Expert Toxicologist at Grupo Ferrer Internacional, Ferrer, Spain
  • In vitro and In vivo genotoxic assays of impurities of new drug
  • General Toxicological evaluation of impurities that cannot be isolated
  • Positive imput from Regulator on the impurities safety assessment genotox+general toxicology
13:10 - 14:30 80 mins
14:30 - 15:05 35 mins
Genotoxic Impurities
Challenges when calculating compound specific exposure limits
  • Patricia Parris - Project Toxicologist, AstraZeneca, UK
15:05 - 15:40 35 mins
Genotoxic Impurities
Benchmark dose modelling of in vivo genotoxicity studies to determine acceptable daily intakes for genotoxic impurities
  • George Johnson - Vice-President EEMGS, Associate Professor, Swansea University Medical School, UK

George Johnson1, Angela White2, Julia Kenny2, and Jim Harvey2
1Institute of Life Science, Swansea University Medical School, SA2 8PP
2GSK R&D, Park Road, Ware, Hertfordshire, SG12 0DP, United Kingdom

The international committee on harmonisation (ICH) have produced the M7 guideline for how genotoxic impurities should be tested and assessed. If during these assessments, a ‘positive’ response is detected and the threshold for toxicological concern (TTC) exceeded, then there is an option to define a permitted daily exposure (PDE). This is carried out by defining a point of departure (PoD) from the in vivo dose response data. The recommendation is to use the no observed effect level (NOEL) as the PoD, however, there is potential to do this using the benchmark dose approach instead. Through a series of case studies, the BMD approach will be shown to perform well on various data sets, and in numerous different scenarios with the advantages discussed.

15:40 - 16:10 30 mins
Afternoon Tea
16:10 - 16:45 35 mins
Genotoxic Impurities
Selecting the Appropriate Analytical Approach for Monitoring Potential Mutagenic Impurities
  • Margaret Maziarz - Principal Scientist, Scientific Operations, Waters Corporation, USA
16:45 - 17:20 35 mins
Genotoxic Impurities
Novel methodologies for trace level analysis
  • Farahat Ali - Pharmacopoeial Associate, Reference Standard Division, Indian Pharmacopoeia Commission, Ministry of Health and Family Welfare, Government of India

Potential Genotoxic impurities (PGTIs) in pharmaceuticals at trace levels are of increasing concerns to both pharmaceutical industries and regulatory body due to their potentials for human carcinogenesis. Determination of these genotoxic impurities at ppm or ppt levels requires highly sensitive analytical methodologies, which poses tremendous challenges on analytical communities in pharmaceutical Research and development. Practical guidance with respect to the analytical determination of diverse classes of PGTIs is currently lacking in the literature.

17:20 - 17:50 30 mins
Genotoxic Impurities
Analytical control strategies for mutagenic impurities: Current challenges and future opportunities
  • Dave Elder - Principal Consultant, David P Elder Consultancy, UK
17:50 - 17:55 5 mins
End of Conference Day One