= Members Only
Educational Course—Virtual Format in 2021!
Toxicology for Pharmaceutical and Regulatory Scientists
Course Description
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. New this year, the course will include Cell and Gene Therapy. 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.
On-demand access to the presentations will be available to registrants for unlimited viewing no later than March 15 until April 9, 2021.
Virtual Features
- ✔ Virtual interactive case studies and break out groups
- ✔ Live Q&A Sessions with Speakers
- ✔ Recorded lectures with unlimited on-demand viewing
Virtual Course Topics
Recordings will be released to registered attendees once available. Register early for maximum access to lectures.
Recorded Lectures
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, Mary Jeanne Kallman, Kallman Preclinical Consulting
General Toxicology, Lorrene Buckley, Eli Lilly and 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.
Genetic Toxicology, Mark Powley, Merck & Co., Inc.
Evaluation of Potential Carcinogenicity, James Popp, Stratoxon LLC
Reproductive/Developmental and Juvenile Toxicology, Alan Hoberman, Charles River
Nonclinical Safety Evaluation of Biotechnology-Derived Therapeutics, Melanie Hartsough, Hartsough Nonclinical Consulting, LLC
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
Preparation of Nonclinical Documents for Regulatory Submission, Marjorie Peraza, Pfizer, Inc.
Live—Interactive Breakout Groups on April 2, 2021
Practical Application: Nonclinical Case Studies
Hanan Ghantous, US Food and Drug Administration
Natalie Holman, Eli Lilly and Company
Katie Sokolowski, US Food and Drug Administration
Times
Live Q&A sessions and case studies with breakout group work with ACT Course speakers and moderators will take place the week of March 29–April 2, 2021 from 11:00 am to 1:00 pm Eastern Time. Click here for the live Q&A schedule.
Course Organizers
Joseph A. Francisco, PhD, Altasciences
Hanan Ghantous, PhD, DABT, US Food and Drug Administration
Timothy McGovern, PhD, US Food and Drug Administration
Jordan Ballance, ACT Staff Liaison
Registration
Virtual Registration Fees:
| ACT Member | $1,295 |
| ACT Student or Postdoc/Transitional | $ 995 |
| Nonmember | $1,595 |
| Government | $1,295 |
| ACT Member Group Rate** (3 or more from same company) |
$1,145 |
| Nonmember Group Rate** (3 or more from same company) |
$1,445 |
| ACT Member Group Rate** (10 or more from same company) |
$1,045 |
| Nonmember Group Rate** (10 or more from same company) |
$1,345 |
**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.
Tel: 703.547.0875 | Fax: 703.438.3113 | Email: acthq@actox.org
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