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Education Course
Toxicology for Pharmaceutical and Regulatory Scientists

This annual ACT course provides basic training in general toxicology. Participants will obtain an overall understanding of the principles of toxicology and nonclinical safety evaluation with a focus on pharmaceutical development. By popular demand, the course will include discussion of regulatory case studies and hands-on analyses of nonclinical data. The course is intended to benefit individuals working with small and large molecules from biotechnology and pharmaceutical companies, CROs, and regulatory agencies, or individuals interested in or currently practicing toxicology.

Monday, April 3, 2023

Principles of Toxicology, A. Wallace Hayes, University of South Florida, College of Public Health
Introduction to Pharmacology for the Toxicologist, Amy Avila, US Food and Drug Administration
Principles of Drug Metabolism and Toxicokinetics and Applications to Pharmaceutical Toxicology, Debie Hoivik, Akebia Therapeutics
Safety Pharmacology for Human Pharmaceuticals, Simon Authier, Charles River


Reception

Please join us for a reception following the course on Monday. This light-fare reception, which is included in the registration fee, allows for fellow course attendees, course organizers, and speakers to interact and network in a casual atmosphere. Hors d’oeuvres, plus drink tickets for beer and wine will be provided to registered participants.

Tuesday, April 4, 2023

General Toxicology, Lorrene Buckley, Eli Lilly & Company
Toxicology of Organ Systems, Mary Beth Genter, University of Cincinnati
Clinical Pathology: Principles for Pharmaceutical and Regulatory Scientists, Lila Ramaiah, Pfizer, Inc.
Pathology in Toxicology Studies, Thomas Steinbach, Experimental Pathology Laboratories, Inc.

Wednesday, April 5, 2023

Genetic Toxicology, Mark Powley, Merck and Co.
Evaluation of Potential Carcinogenicity, James Popp, Stratoxon
Reproductive/Developmental and Juvenile Toxicology, Alan Hoberman, Charles River
Nonclinical Safety Evaluation of Biotechnology-Derived Therapeutics, Melanie Hartsough, Hartsough Nonclinical Consulting, LLC

Thursday, April 6, 2023

Immunotoxicology, Florence Burleson, Burleson Research Technologies, Inc. (BRT)
Risk Assessment, Melissa Rhodes, Kriya Therapeutics
Regulatory Toxicology—A Nonclinical Pharmacology and Toxicology Perspective, Hanan Ghantous, US Food and Drug Administration
Cell and Gene Therapy, Sandhya Sanduja, US Food and Drug Administration
Practical Application: Nonclinical Case Studies, Hanan Ghantous, US Food and Drug Administration, Natalie Holman, Eli Lilly and Company, Katie Sokolowski, Denali Therapeutics

Friday, April 7, 2023*

Preparation of Nonclinical Documents for Regulatory Submission, Marjorie Peraza, Pfizer, Inc.
Label Review of Drug L, Hanan Ghantous, US Food and Drug Administration
Review of Drug L: History and Outcome, Kenneth Hastings, Hastings Toxicology Consulting, LLC

*Course ends at noon.


Daily continental breakfast, snack breaks, and lunch are provided as part of the registration. Detailed course handouts will be provided electronically. Participants must bring personal computer to view materials. Please ensure to download materials before arriving. Internet will not be provided.

Times:

Registration and Check-In: Monday, 7:00 AM–8:00 AM
Reception: Monday, 4:15 PM–5:30 PM

Course:
Monday–Thursday, 7:45 AM–5:00 PM;
Friday, 8:00 AM–12:00 Noon

Hanan Ghantous, PhD, DABT, US Food and Drug Administration

Timothy McGovern, PhD, US Food and Drug Administration

Jordan Ballance, ACT Staff Liaison

Narcisa Despoiu, ACT Staff Liaison

Masks Strongly Encouraged

The American College of Toxicology will follow current science-based information and is fully committed to taking appropriate precautions to provide a safe and healthy environment for participants of the course. ACT will continue to monitor the COVID-19 situation along with local and federal guidelines. Based on current health mandates, ACT will not require proof of vaccination or proof of a negative PCR test. However, the local mandates could change; therefore, we ask that individuals bring a mask and proof of vaccination on their person. You may also want to consider bringing an at-home COVID-19 test kit with you.

Mask wearing is a prudent measure to prevent spread of viruses and is strongly encouraged during the meeting. Additionally, vaccination has been proven to be effective in preventing hospitalization and death from COVID-19. ACT expects that course attendees use the CDC’s self-checker website daily. Should you feel unwell or suspect you have been exposed to COVID-19, we ask that you isolate. Please stay home if you feel sick.


Registration Form

Registration Fees:

Early-Bird Registration
(Received by January 9)
Regular Registration
(Received January 10–March 31)
ACT Member $1,500 $1,600
ACT Student or Postdoc Member $995 $1,095
Nonmember $1,800 $1,900
Government $1,500 $1,600
ACT Member Group Rate**
(3 or more from same company)
$1,350 $1,450
Nonmember Group Rate**
(3 or more from same company)
$1,650 $1,750
ACT Member Group Rate**
(10 or more from same company)
$1,250 $1,350
Nonmember Group Rate**
(10 or more from same company)
$1,550 $1,650

**To take advantage of the group rate: Please send your completed registration forms to ACT Headquarters. You will not be able to select the group rate through the online registration. All three forms (or more) should be emailed at the same time.

Refund Policy: $100 Processing Fee will be charged before 1/9/23; 50% refund if canceled before 2/6/23; After 2/6/23, no fees will be refunded.

Course Location

Gaithersburg Marriott Washingtonian Center
9751 Washingtonian Boulevard
Gaithersburg, MD 20878

Hotel

Gaithersburg Marriott Washingtonian Center
9751 Washingtonian Boulevard
Gaithersburg, MD 20878
Tel: 301.590.0044
Hotel Reservations: 800.228.9290

Housing Deadline

Please refer to the TPRS Room Block to make your housing reservation. The ACT TPRS meeting rate of $215 (plus tax) is offered over the dates of April 2–7, 2023, based on availability, and reservations must be made by March 10, 2023.

Requirements

A personal laptop to view course materials and your computer charger are required. Please download all the course materials to your laptop prior to arriving at the course. Course materials will be provided approximately one week before the start of the course.

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