Practical Toxicology in Drug Development
Industrial Short Course
Pyle Center
May 3-5, 2010
Madison, WI
On Campus Short Courses for the Pharmaceutical Industry
Registration
Your registration options are as follows:
The registration is $1045.00 and Early bird discounts ($845) are offered to individuals registering prior to April 16/2010).
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Register Online. Login in using your user account. If you don't have a user account creating one is free & easy. |
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Download the registration form, complete & mail to: Pharmacy Short Courses |
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By phone at 608-262-3132 or 608.262.3130 or toll-free at 877-947-4255 using a credit card for payment. |
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Download the registration form, complete & fax to 608.262.2431 using a credit card for payment. |
Goals & Objectives
The intent of this short course is to provide a foundation to introduce the participant to toxicology applications in drug development. The course will cover the regulatory, scientific, and strategy of employing non clinical toxicology methods and provide a basic understanding of the value and limitations of non clinical safety evaluations. An integrated approach will be applied so that the participants will be able to understand how the toxicology fits into the drug development process. The course will also cover innovations in the discipline that will change the time and cost of the development of new pharmaceuticals.
Applications of toxicology studies will be emphasized with case study simulations to apply principals discussed in the course. Upon completion, the learner should be able to:
- describe the difference in toxicology studies required for candidate selection versus regulatory submission;
- describe the safety evaluation process involved with a pre-IND and product registration packages;
- discuss general toxicology considerations with respect to acute vs. repeated dose studies;
- list commonly used toxicology end points;
- identify unique issues associated with reproductive toxicology and carcinogenic studies;
- discuss potential impacts on toxicology caused by manufacturing changes;
- describe potential approaches to safety evaluation of biotechnology products, combination products and cell-based therapies; and
- apply principles learned to case simulations.
Special Offer for Academic Institutions
Extension Services in Pharmacy at the University of Wisconsin School of Pharmacy has instituted a new policy for industrial professional development programs to encourage greater participation by faculty, graduate students and post doctoral students at academic institutions. Programs will be offered at a significantly reduced price, based on space availability. For information about any specific course please contact Dr. James E. De Muth by email.
Short Course Program General Information
Who should attend
The course in designed for non-toxicologists involved in pharmaceutical development. Some experience within drug industry is recommended.
Location
Courses are presented on the University of Wisconsin-Madison Campus. Springtime in Madison and the beauty of the on-campus location provide a relaxing atmosphere for learning. Evenings can be used to explore the University and the city named by Money magazine as the "best place to live in America" in 1996. For more information about Madison, WI visit www.visitmadison.com
Accommodations
On-campus housing is available to short course registrants in the same building where the courses are presented. Housing information will be sent to individuals when they receive their registration confirmation. Other hotels are also conveniently located around the campus. The approximate cost per night is $90.
Ending/Starting Times
Unless otherwise indicated in the course description, programs traditionally end at approximately 11:00 to 11:30 AM on the last day of the class. This allows participants to make reservations for return flights the same day.
Enrollment & Fees
Unless otherwise indicated, enrollment will be limited to 30 individuals per short course. The registration fee of $1045 ($845 prior to April 16) includes instructional costs, course materials, and coffee breaks, and lunches. Cancellations after April 16 are non-refundable. Cancellations prior to April 16 are subject to a $75 administration fee. In the event that an accepted applicant cannot attend, a substitute may be sent by the same company. Early bird discounts ($845) are offered to individuals registering prior to April 16, 2010. In previous years, most short courses filled before the early registration deadline. You are encouraged to register early to avoid not being able to be included in the program.
Contents
• Safety evaluation in drug candidate selection (discovery process and decision-making versus regulatory submissions)
• Introduction to Pre-IND Safety Evaluation
o Typical package introduction (ICH guidance, impact of different indications, world market regulations)
o Species selection
• Genetic toxicology
• Safety pharmacology
• General Toxicology
o Acute and repeated dose studies
o Rodent vs. non-rodent designs
o Toxicology endpoints
o Toxicokinetics
o No-observable effect levels and therapeutic exposure multiples
• Reproductive Toxicology
• ADME Considerations (PK/metabolism as related to toxicology)
• Carcinogenicity studies (range findings, rat and mouse study designs, CAC documents, alternative models)
• Impact of drug substance changes; impurities, salt forms and worker safety requirements
• Special consideration related to toxicology, including issues presented by biotechnology products, combination drugs, and cell-based therapies
Instructors
Debra Kirchner, Ph.D., DABT
Senior Program Manager
Program Management Services
Covance Laboratories. Inc.
Madison, WI
John E. Sagartz, DVM, Ph.D.
President
Seventh Wave Laboratories, LLC
Chesterfield, MO
Peter J. Sausen, Ph.D., DABT
Executive Director, Program Management Services
Covance Laboratories
Madison, WI
Philip Teitelbaum, Ph.D.
Program Manager, Drug Metabolism
Covance Laboratories. Inc.
Madison, WI
For More Information
James E. De Muth, Ph.D., Conference Director
Extension Services in Pharmacy
777 Highland Avenue
Madison, WI 53705
(608) 262-3130
FAX (608) 262-2431
Send Email
