Hotel Information:
Hyatt Arlington
Hyatt Arlington
1325 Wilson Boulevard
Arlington, VA 22209
(703) 525-1234
Rate: $
239
Deadline for Group Rate:
2010-08-08
Hotel Policy
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Registration Rate:
$1,495.00 Register by 08/8/10
$1,695.00 Register after 08/8/10
Cancellation Date: 9/13/10 (Cancellation fee is determined by date cancelled.)
Register Now
Registration Policy
Continuing Education Credit:
ACPE:
0708-0000-10-030-L01-P (1.4 CEU)
Initial Release Date:
9/22/10
CBRN:
N/A
CME:
14 Hours of Category 1 Credit
VNA:
07-04-01 14 Contact Hours
Continuing Education Policy
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Course Description:
This course will be held at:
The PERI Training Facility
1616 N Fort Myer Drive Suite 1430
Arlington, VA 22209
Day 1: 8:00 AM - 5:00 PM
Day 2: 8:00 AM - 5:00 PM
This course provides the essential foundation for toxicology in the nonclinical development and regulatory approval of drugs and biologics. FDA-required nonclinical safety studies and ICH guidelines for the IND and NDA/BLA will be covered. Nonclinical toxicology is presented in the context of successful development plans that cover how safety studies integrate with nonclinical pharmacology, pharmacokinetic/toxicokinetic studies and the chemistry and clinical parts of the project. This is one of the critical courses for learning how ¿risk/benefit¿ assessments are made.
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Who Should Attend:
This course should be required training for all drug developers, not just toxicologists. It is invaluable to chemistry, nonclinical, clinical, and regulatory staff because of the mutual dependency among these disciplines for successful safety assessments and clinical trials of new drugs. A solid foundation for professional development of doctoral, administrative, project management, and laboratory support staff is provided.
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Educational Objectives:
Upon completion of this course, participants should be able to:
•Describe the FDA and ICH requirements for safety studies
•Design an integrated nonclinical development plan
•Present nonclinical data to FDA
•Determine how toxicology studies are mutually dependent upon pharmacology, pharmacokinetic, clinical trial design, and physical/chemical/biological characterization of the test material
•Define what "case-by-case" means in nonclinical development and how it influences safety assessments
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Key Topics:
•Designing Nonclinical Toxicity Studies in Relationship to the Rest of the Project Plan
•How Nonclinical Toxicology Studies Support Clinical Development and Clinical Risk/Benefit Decisions
•Pharmacokinetics
•Toxicokinetics
•Pre-IND Consultation Program
•Safety Pharmacology Studies
•Ophthalmic Drug Development Toxicology Requirements
•Itravenous Toxicology Studies
•Genetic Toxicology
•Carcinogenicity Studies
•Reproductive Toxicology
•Immunotoxicological Evaluation INDs
• Dose Range-Finding and Repeated Dose Toxicity Studies
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Course Director(s):
Peter C Hoyle, PhD
President
Hoyle Consulting Inc.
For a complete list of faculty or an agenda, please contact the course manager.
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Contact Course Manager:
Course Manager
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PERI reserves the right to change agenda
items and instructors without notice to accommodate
situations beyond its control.
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