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2019 Educational Course

Toxicology for Pharmaceutical and Regulatory Scientists

Course Description

This annual ACT course provides basic training in general toxicology. Using pharmaceutical development as examples, participants will obtain an overall understanding of the principles of toxicology and nonclinical safety evaluation. 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.

Course Flyer

Course Schedule

Monday, April 8

8:10 AM–10:00 AM

Principles of Toxicology, A. Wallace Hayes, University of South Florida, College of Public Health

10:15 AM–11:45 AM

Introduction to Pharmacology for the Toxicologist, Amy Avila, US Food and Drug Administration

1:00 PM–2:30 PM

Principles of Drug Metabolism and Toxicokinetics and Applications to Pharmaceutical Toxicology,
Debie Hoivik, Boehringer-Ingelheim Pharmaceuticals, Inc.

2:45 PM–4:15 PM

Safety Pharmacology for Human Pharmaceuticals, Mary Jeanne Kallman, Kallman Preclinical Consulting

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 9

8:00 AM–9:45 AM

General Toxicology, Lorrene Buckley, Eli Lilly & Company

10:00 AM–12:00 Noon

Toxicology of Organ Systems, Mary Beth Genter, University of Cincinnati

1:00 PM–2:30 PM

Clinical Pathology: Principles for Pharmaceutical and Regulatory Scientists, Lila Ramaiah, Bristol-Myers Squibb

2:45 PM–4:15 PM

Pathology in Toxicology Studies, Thomas Steinbach, Experimental Pathology Laboratories, Inc.

Wednesday, April 10

8:15 AM–9:45 AM

Genetic Toxicology, Mark Powley, Merck and Co.

10:00 AM–12:00 Noon

Evaluation of Potential Carcinogenicity, James Popp, Stratoxon LLC

1:00 PM–2:50 PM

Reproductive/Developmental and Juvenile Toxicology, Alan Hoberman, Charles River

3:00 PM–4:30 PM

Nonclinical Safety Evaluation of Biotechnology-Derived Therapeutics, Melanie Hartsough, Hartsough Nonclinical Consulting, LLC

Thursday, April 11

8:15 AM–10:15 AM

Immunotoxicology, Florence Burleson, Burleson Research Technologies, Inc. (BRT)

10:30 AM–12:00 Noon

Regulatory Toxicology—A Nonclinical Pharmacology and Toxicology Perspective, Hanan Ghantous, US Food and Drug Administration

1:00 PM–2:30 PM

Risk Assessment, Melissa Rhodes, Altavant Sciences

2:45 PM–4:15 PM

Practical Application: Nonclinical Case Studies, Hanan Ghantous, US Food and Drug Administration

Friday, April 12

8:00 AM–9:30 AM

Preparation of Nonclinical Documents for Regulatory Submission, Paul Nugent, Pfizer, Inc.

10:45 AM–11:45 AM

Review of Drug J: 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.

Times

Registration and Check-In: Monday, 7:00 AM–8:00 AM

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

Course Organizers

Joseph A. Francisco, PhD, Charles River
Hanan Ghantous, PhD, DABT, US Food and Drug Administration
Timothy McGovern, PhD, US Food and Drug Administration
Jordan Ballance, ACT staff liaison

Registration

Online Registration

Registration Form

Registration Fees:

  By Feb. 4 Feb. 5–April 5
ACT Member $1,295 $1,395
ACT Student and Postdoc Member $995 $1,095
Nonmember $1,595 $1,695
Government $1,295 $1,395
ACT Member Group Rate**
(3 or more from same company)
$1,145 $1,245
Nonmember Group Rate**
(3 or more from same company)
$1,445 $1,545

**To take advantage of the group rate: Please send your completed registration forms to acthq@actox.org. You will not be able to select the group rate through the online registration.

Refund Policy:

$75 Processing Fee will be charged before 2/4/19; 50% refund if canceled before 3/4/19; After 3/4/19, no fees will be refunded.

Course Location

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

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 ACT TPRS Room Block to make your housing reservation. The ACT TPRS meeting rate of $199 (plus tax) is offered over the dates of April 5–15, 2019, based on availability, and reservations must be made by March 11, 2019.


















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