= Members Only
Toxicology for Industrial and Regulatory Scientists
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.
This course is sponsored by MPI and has support from the Society of Toxicology.
Monday, April 27
Principles of Toxicology, A. Wallace Hayes, Harvard School 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 Industrial Toxicology, Matthew Bogdanffy, Boehringer-Ingelheim Pharmaceuticals, Inc.
Safety Pharmacology for Human Pharmaceuticals, Russell Bialecki, AstraZeneca Pharmaceuticals
Please join us for a reception following the class on Monday, April 27. 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. Hot and cold hors d’oeuvres, plus nonalcoholic beverages will be provided. A shuttle will be available immediately after the reception to take participants back to the hotel.
Tuesday, April 28
General Toxicology, Lorrene Buckley, Eli Lilly & Company
Toxicology of Organ Systems, Mary Beth Genter, University of Cincinnati
Clinical Pathology: Principles for Industrial and Regulatory Scientists, Robert Hall, Covance Laboratories Inc.
Pathology in Toxicology Studies, Thomas Steinbach, Experimental Pathology Laboratories, Inc.
Wednesday, April 29
Genetic Toxicology, Mark Powley, US Food and Drug Administration
Evaluation of Potential Carcinogenicity, James Popp, Stratoxon LLC
Reproductive/Developmental Toxicology, Kok Wah Hew, Takeda Pharmaceutical Company
Immunotoxicology, Gary Burleson, Burleson Research Technologies, Inc. (BRT)
Thursday, April 30
Nonclinical Safety Evaluation of Biotechnology-Derived Therapeutics, Melanie Hartsough, Biologics Consulting Group, Inc.
Regulatory Toxicology—A Nonclinical Pharmacology and Toxicology Perspective, Hanan Ghantous, US Food and Drug Administration
Risk Assessment, Ernie Harpur, Newcastle University, UK
Practical Application: Nonclinical Case Studies, Hanan Ghantous, US Food and Drug Administration
Friday, May 1*
Regulatory Toxicology of Chemical, Agrochemicals, and Other Nonpharmaceuticals, William Brock, Brock Scientific Consulting, LLC
Review of Drug F: 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.
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
This course is sold out. Please contact ACT Headquarters if you would like to be placed on the waiting list.
|By March 2||March 3–April 24|
$75 Processing Fee will be charged before 3/2/15; 50% refund if canceled before 3/24/15; After 3/24/15 no fees will be refunded.
The course is held at the MedImmune Headquarters
One MedImmune Way
Gaithersburg, MD 20878
Courtyard Gaithersburg Washingtonian Center
204 Boardwalk Place
Gaithersburg, MD 20878
Hotel Reservation: 800.321.2211
ACT Room Block Rate: $165, plus tax
The deadline for housing reservations is Monday, April 6, 2015.
A special bus will take course participants from the Marriott to the course site at MedImmune Headquarters. If you plan to use your own transportation and park at the MedImmune Campus, please indicate so on the Registration Form, so space may be reserved.
- A personal laptop to view course materials.
- A photo ID to enter the MedImmune campus.