Registration Rate:
Regular Registration Fee: $415
ACS/Gov Registration Fee: $315
Cancellation Fee: $
Registration Policy
Register Now Online
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Continuing Education Credit:
ACPE: 708-000-08-008-H03-P/T - 0.50 CEU
Initial Release Date: 5/14/08
CME: 5 Hours of Category 1 Credit
VNA: 07-04-01 5 Contact Hours
Continuing Education Policy
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Course Description:
This introductory web-based module focuses on the critical decisions that are made throughout the development of a new chemical entity as the process evolves from discovery to first in humans and ultimately to launch. These decisions include identifying a lead, choosing a compound for development, conducting pre-clinical work to assess which drugs should go to clinic, determining that drugs are safe in the clinic, establishing the dose, generating a label, and deciding to file an NDA. A key element of the module is a discussion of how the product label drives the drug development process. The difference between an activity based and a knowledge based drug development process is also addressed. You should expect to spend approximately 5 hours of study time to complete the course. You will have a two-month access after you register for the course.
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Who Should Attend:
This module will be of particular interest to individuals new to drug development who need a brief introduction to the overall process, the functional areas contributing to the development of a new drug, and the critical decisions being made. This module provides an excellent overview for the new drug development team member from any discipline.
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Educational Objectives:
- Differentiate between traditional and contemporary knowledge-based drug development processes
- Describe each knowledge-based phase of the drug development process with a focus on safety and effectiveness
- Explain the value of a "label-driven/question-based" approach to drug development
- Define critical decision points in the clinical candidate selection, development and regulatory review processes
- Utilize the questions and critical decision points to design a question-based drug development plan
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Key Topics:
- History of Drug Regulation: Who Regulates and Why
- Contemporary, Knowledge-Based Drug Development as Compared to the Traditional, Activity-Based Approach
- Critical Drug Development and Review Decision Points
- Successful and Failed Drug Development Programs
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Course Director(s):
Charles V. Grudzinskas, PhD
Drug Development Consultant
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Contact Course Manager:
Course Manager
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