ESTP Expert Workshop
Monday 22 September 2025
The ESTP International Expert Workshop will be organized in the Hilton Deansgate Hotel in Manchester.
303 Deansgate
Manchester M3 4LQ
United Kingdom
W: Hilton Manchester Deansgate | Central Manchester
Adversity determination of female reproductive findings in animals and significance for humans
The topic of the 11th ESTP International Expert Workshop, which will take place on September 22nd, 2025, in Manchester, UK will be “Adversity determination of female reproductive findings in animals and significance for humans.” The workshop was prepared by a group of 21 experts from diverse backgrounds in toxicopathology, clinical pathology, reproductive toxicology as well as regulatory toxicology.
The workshop will start with a review of adversity determination in nonclinical toxicology studies, to set the stage for a more focused discussion on the challenges of determining adversity in the female reproductive system. The resulting guiding principles for adversity determination will be then summarized.
Further presentations will discuss the translatability to humans, including overall assessment of female fertility risk throughout development and factors which may contribute to it, such as e.g. therapeutic indication and mode of action. Also, the differences between pharmaceutical and agrochemical regulatory environment will be highlighted. The talks will be intermingled with interactive case presentations with audience participation by an electronic voting system.
The workshop will end with an open discussion between the audience and experts, after which conclusions and recommendations for adversity determination of female reproductive findings in animal toxicology studies and integrated reproductive risk assessment will be summarized.
PROGRAM
08.20 – 08.30 | Welcome and Introduction
08.30 – 08.50 Introduction to adversity determination in nonclinical toxicology studies and overview of current best practices | Sean Troth & Daniel Patrick
08:50 – 09:30 | Interactive Case Presentations
09:30 – 10:30 | Challenges of adversity determination for female reproductive toxicity findings | Pragati Coder
09.30 - 10.30 | Guiding principles for adversity assessment specific to female reproductive findings | Justin Vidal
10:30 – 11:00 | Morning Coffee Break
11.00 – 12.30 | Female fertility risk assessment throughout drug development and labeling | Christopher Bowman
11.00 - 12.30 | Influence of therapeutic indication and MoA on assessment of human risk - including interactive case presentation| Nicole Principato
12.30 – 13.30 | Lunch
13.30 – 14:45 | Communication of adversity and their implications for human risk – Part 1 | Daniel Patrick
13.30 - 14.45 | Influence of regulatory environment on human risk assessment | Heike Marxfeld & Doris Hoeschele
14:45 – 15:15 | Interactive Case Presentations
15.15 – 15.45 | Afternoon Coffee Break
15.45 – 16.15 | Communication of adversity – Part 2 | Justin Vidal & Daniel Patrick
16:15 – 17:30 | Discussion/Questions from the audience
16.15 - 17.30 | Expert discussion and conclusions
17:30 | End of workshop
The expert panel of the ESTP Expert Workshop
Roger Alison
Ute Bach
Bernd Baier
Emmanuelle Balme
Christopher Bowman
Pragati Coder
Eveline De Rijk
Beth Dray
Laetitia Elies
Johannes Harleman
Doris Hoeschele
Maike Huisinga
Monika Keresztes
Heike Marxfeld
Luann Mckinney
Daniel Patrick
Nicole Principato
Mikala Skydsgaard
Sean Troth
Jan Willem Van der Laan
Justin Vidal
Registration fee
Early fee on or before 22 June 2025
ESTP member - Early Bird Fee: € 195.00
ESTP member - Late Fee: € 210.00
Non-member - Early Bird Fee: € 210.00
Non-member - Late Fee: € 230.00
Prices are incl. 20% UK VAT
The registration fee includes
• Admission to the Expert Workshop
• Coffee breaks
• Lunch
How to register
In order to register for the Expert Meeting and / or the BSTP/ESTP congress please register online and be sure to submit your registration. Upon receipt of your completed registration form and payment, you will receive an email confirmation of your registration.