Hosted by: European Society of Toxicologic Pathology

Co-sponsored by:	British Society of Toxicological Pathology
	French Society of Toxicological Pathology
	Society of Toxicologic Pathology

Publications about general principles of adversity and NOAEL (No-Observed-Adverse-Effect-Level) assignments in toxicology are numerous, but do not offer sufficient practical guidance. Recognizing the increasing importance of this topic for toxicologic pathology, the ESTP conducted a workshop comprised of 21 international expert pathologists and toxicologists from the pharmaceutical and chemical industry, contract research organizations, and international regulatory authorities. After several preparatory teleconferences, a face-to-face meeting and expert discussion was held in Alfortville (Paris), France on 8-9 June, 2015.

Presentations of this webinar are based on the expert contributions to this workshop.

The goal of this webinar is to present considerations, key and modifying factors which help to interpret histomorphological changes in nonclinical studies as adverse or non-adverse, and to highlight the different implications of adversity decisions across the various fields of our professional activity.

Who should attend? Pathologists and toxicologists involved in the interpretation of test item-related pathological findings in preclinical and toxicological animal studies.

Part I: October 15, 2015 from 1:30 to 3:00 pm (CET) | 7:30 to 9:00 am (EDT):

"Regulatory Viewpoints and Pathologist Considerations for Pharmaceutical and Environmental Chemicals"

Presenter	Topic
Wolfgang Kaufmann (Merck KGaA, Germany)	Current Definitions of the Term "Adverse"
John Burkhardt (AbbVie, USA) and Sabine Francke (FDA, USA)	Adversity Evaluation in Submissions to US FDA
Charles Wood (US EPA, USA)	US Perspective: Interpretive Issues & Weight-of-Evidence Considerations in Evaluating Adversity
Lindsay Tomlinson (Pfizer, USA)	Adversity Considerations in Clinical Pathology
Henri Caplain (Consultant; Sanofi, retired, France)	Adversity and Adverse Events in Clinical Trials
John Burkhardt (AbbVie, USA)	STP: "Best Practices" Document for Defining and Communicating Adversity

Registration for Part I

Part II: October 27, 2015 from 1:30 to 3:00 pm (CET) | 8:30 to 10:00 am (EDT)

"Characterizing Factors of Adversity and Other Issues of Adversity Interpretation and Translatability to Humans"

Presenter	Topic
Sibylle Gröters (BASF SE, Germany)	Adversity Related to Mode of Action
Gabriele Pohlmeyer-Esch (KALEIDIS Consultancy, France)	Adversity of Exacerbated Spontaneous Lesions
John Foster (Consultant; AstraZeneca, retired, UK)	Adverse Versus non-Adverse – the Role of Adaptation
Mikala Skydsgaard (Novo Nordisk, Denmark)	Adversity and Reversibility
Hans Harleman (Fresenius Kabi, Germany) and Pierluigi Fant (WIL Research, France)	Adversity of Effects on the Immune and Hemopoietic System
Paul-Georg Germann (AbbVie, Germany)	Adversity and Translatability to Humans: Two Cases

Registration for Part II