HESI Workshop
Quantitative Interpretation of Genetic Toxicity Dose-response Data for Risk Assessment and Regulatory Decision-making – State of the Science, Applications, and Persistent Challenges
Andreas Zeller (Roche), George Johnson (Swansea University), Paul White (Health Canada)
on behalf of the HESI GTTC
HESI Workshop | Monday 15th May: 9:00 - 15:00 (Forum 2) |
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8:00 - 9:00 | Registration & Breakfast |
Quantitative Dose-response Analyses: State of the Science | |
9:00 - 9:10 | Welcome & Overview of Workshop Goals Co-chairs: Andreas Zeller (Roche, SWITZERLAND), George Johnson (Swansea University, UK), Paul White (Health Canada, CANADA) |
9:10 - 9:40 | Quantitative Interpretation of In Vivo Mutagenicity Dose Response Data for Risk Assessment and Regulatory Decision-Making Paul White (Health Canada, CANADA) & Stefan Pfuhler (Procter and Gamble, USA) |
9:40 - 10:10 | The interpretation of in vitro dose-response data for risk assessment and regulatory decision-making Marc Beal (Health Canada, CANADA) |
10:10 - 10:40 | Guided Discussion |
10:40 - 11:10 | Coffee Break |
Application of Quantitative Data Interpretation to Pharmaceutical Impurities | |
11:10 - 11:40 | Nitrosamine impurity issues and potential resolutions George Johnson (Swansea University, UK) |
11:40 - 12:10 | In vivo genetic toxicity assessments for nitrosamines Maik Schuler (Pfizer, USA) or Shaofei Zhang (Pfizer, USA) |
12:10 - 12:40 | Defining a NOGEL for mutation induction in Muta™Mouse following exposure to N-Nitrosodimethylamine (NDMA) Anthony Lynch (GlaxoSmithKline, UK) |
12:40 - 13:40 | Lunch |
13:40 - 14:10 | Regulatory considerations related to mutagenic impurities in pharmaceuticals Roland Frotschl (BfArM, GERMANY) |
14:10 - 14:50 | Guided Discussion |
14:50 - 15:00 | Concluding Remarks |
El Merendero de Antonio Martín
Pl. de la Malagueta, 4, 29016 Málaga
11:00 – 11:30
Coffee Break
13:00 – 14:00
Lunch
14:30 – 16:00
Poster Session 1 & Sponsor Visit
(while coffee is served)
16:00 – 17:00
Chromosome instability, DNA repair deficiency and cancer: insights from Fanconi anemia
Jordi Surrallés (Keynote Speaker)
(Santa Creu i Sant Pau Hospital Research Institute Foundation, SPAIN)
18:30 – 20:30
Social Event
Plaza de la Merced
(meeting point)
11:00 – 11:30
Coffee Break
13:00 – 14:00
Lunch
14:30 – 16:00
Fritz Sobels & Early Career Awards
16:00 – 17:30
Poster Session 2 & Sponsor Visit
(while coffee is served)
17:30 – 18:30
EEMGS General Assembly
18:30 – 19:30
SEMA General Assembly
20:30 – 00:00
Congress Dinner
El Balneario - Baños del Carmen
C/ Bolivia, 26, 29018 Málaga
13:00 – 13:30
Closing Ceremony

HUMN Workshop
The buccal micronucleus (MN) cytome assay – New Horizons for its implementation in human biomonitoring and clinical studies
Michael Fenech (University of South Australia), Siegfried Knasmueller (Medical University of Vienna Institute of Cancer Research), Stefano Bonassi (San Raffaele University)
HUMN Workshop | Thursday 18th May: 14:00 - 17:30 (Forum 2) |
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13:00 - 14:00 | Registration & Lunch |
Early afternoon Session 14:00 - 15:40 | |
14:00 - 14:10 | Welcome & Overview of Workshop Goals Co-chairs: Michael Fenech (Genome Health Foundation, AUSTRALIA), Siegfried Knasmueller (Medical University of Vienna, AUSTRIA), Stefano Bonassi (IRCCS San Raffaele Roma, ITALY) |
14:10 - 14:40 | The biology of buccal cells and the buccal micronucleus (MN) cytome assay Claudia Bolognesi (Ospedale Policlinico San Martino, ITALY) |
14:40 - 15:10 | Use of buccal cytome assays in the occupational exposure studies Georg Wultsch (Medical University of Vienna, AUSTRIA) |
15:10 - 15:40 | Association of buccal MN cytome assay biomarkers with disease and their relevance for clinical studies Stefano Bonassi (IRCCS San Raffaele Roma, ITALY) |
15:40 - 16:00 | Coffee Break |
Late afternoon Session 16:00 - 17:30 | |
16:00 - 16:30 | Impact of nutrition and life style on formation of micronuclei and other nuclear anomalies in buccal cells Siegfried Knasmueller (Medical University of Vienna, AUSTRIA) |
16:30 - 16:45 | Automation of the Buccal Micronucleus Cytome Assay Michael Fenech (Genome Health Foundation, AUSTRALIA) |
16:45 - 17:00 | Artificial Intelligence in Microscope-Based Imaging: Automation of the Buccal Micronucleus Cytome Assay? Christian Schunck (MetaSystems, GERMANY) |
17:00 - 17:30 | Discussion on knowledge gaps regarding the buccal MN cytome assay and a roadmap for its translation into practice (open to all participants) |