Training Course:Non-Clinical Drug Safety Evaluation and Drug DevelopmentSchool/Trainer:The Center for Professional Advancement
East Brunswick, New Jersey, United States
Course Format: Classroom | E-learning | Virtual Class | Online | On-site | Blended | Self-paced
Course Description:
'' This course provides a comprehensive explanation of the nonclinical development of drugs and biologics, emphasizing the principles of pharmaceutical toxicology and the assessment of product safety. In addition to the different types of toxicity studies in modern pharmaceutical development, it also describes the relationship between pharmacology, clinical trial design, regulatory strategy and project management.
Emphasis will be placed on how toxicity studies are integrated into the multidisciplinary development plans of new drugs and biologics, and how they affect development decisions. Regulatory affairs will be covered, and descriptions given of the European and the U.S. FDA requirements, the new drug review process, and common regulatory errors.
The goal of this course is to give a working knowledge of pharmaceutical toxicology and drug development to enable you to develop new drugs faster and more efficiently.
There will be ample opportunities for participants to introduce topics for discussion and to interact with the faculty. The ¡°IND Game¡± will provide practical experience in early drug development.
...''
Please go to the school's official website for training price and schedule:
http://www.cfpa.com
Phone:(732)238-1600
School Address:
Corporate Office
Box 7077, 44 West Ferris Street
East Brunswick, NJ USA 08816-7077
Phone: (732)238-1600
Fax: (732)238-9113
Email info@cfpa.com
Europe Office
Oudezijds Voorburgwal 316A, 1012 GM
Amsterdam, The Netherlands
Phone +31/20/638.28.06
Fax +31/20/620.21.36
Email amsterdam@cfpa.com
Jobs & Resumes: East Brunswick
Houses & Roommates: East Brunswick
Other training courses offered by The Center for Professional Advancement:
ISO 13485, ISO 9001 and QSR Regulations for Medical Device Companies
Project Management
Risk Analysis & Human Factors Engineering
Gums and Hydrocolloids
Microencapsulation and Particle Coating
Documentation Management and Control
Analytical Methods Validation for FDA Compliance
Drug Product Stability and Shelf-Life
Microbiological Control and Validation
Process Validation for the Pharmaceutical and Medical Device Industry
ADME: Absorption, Distribution, Metabolism and Elimination
Root Cause Investigation for CAPA
Complaint Procedures for Medical Devices
Early Stage Clinical Studies for Drugs and Devices
Drug Delivery Technologies
Drug Specifications for APIs and Drug Products
The Quality System
Good Clinical Practices (GCP)
Generic Drug Approvals
Notice: The course description on this page was captured from the Internet as historical reference or submitted by visitors. It was archived statically and not updated from day to day.
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