Hotel Information:
Hyatt Arlington
Hyatt Arlington
1325 Wilson Boulevard
Arlington, VA 22209
(703) 525-1234
Rate: $
239
Deadline for Group Rate:
2010-01-30
Hotel Policy
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Registration Rate:
$1,595.00 Register by 02/5/10
$1,795.00 Register after 02/5/10
Cancellation Date: 2/28/10 (Cancellation fee is determined by date cancelled.)
Course Completed
Registration Policy
Continuing Education Credit:
ACPE:
0708-0000-10-003-L03-P (1.4 CEU)
Initial Release Date:
3/1/10
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
In a blending of online and live learning, this course will provide an overview of the process and issues common to all new chemical entity (NCE) development projects. The course will focus on the decisions that need to be made throughout the drug development process and the criteria influencing these decisions. The faculty for this Gold Standard course are selected as experts in their field. The online component is PERI¿s Decision Points Course. PERI strongly recommends that participants complete the online component before attending the live course as concepts covered in the online component will be built upon in the live portion. To review the online course Decision Points, click here. Please note: You do not need to register for both the live AND online components. Upon registering for Pharmaceutical Development: From Molecule to Market, you will automatically receive access instructions to the online course in your Confirmation Letter.
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Who Should Attend:
Those in domestic or international pharmaceutical companies who are new to drug development or other interested individuals who desire a comprehensive overview of the drug development process. This course provides an excellent introduction for the new drug development team member from any discipline. It is equally valuable to scientific and non-scientific staff regardless of training or level.
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Educational Objectives:
Upon completion of this course, participants should be able to:
•Upon completion of this course, participants should be able to:
• Identify the basic steps in the drug development process
• Distinguish between research and development
• Identify the key decision points in the development process
• Explain the implications of label based drug development
• Examine the role of interaction with FDA and other regulatory agencies
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Key Topics:
• Drug Discovery
• Decision Points in Drug Development
• Regulatory Review Process (FDA, EMEA)
• Pharmaceutical Dosage Form Development
• Nonclinical Drug Safety
• Clinical Operation Plan
• Marketing Input in the Drug Development Team
• The NDA: Striving for Quality and Access
• Panel Discussion with FDA Representatives: Putting It All Together
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Course Director(s):
Kevin P Malobisky, M.S., RAC
Senior Director, Regulatory R&D Portfolio, Global Head-Metabolism
sanofi-aventis
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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