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Untitled Document
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Prescription Drug Labeling Regulations: The United States, Canada and the European Union
Course # T15
April 12 - April 13, 2010
Start - 8:00
Finish - 4:00
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Hotel Information:
Hyatt Arlington
Hyatt Arlington
1325 Wilson Boulevard
Arlington, VA 22209
(703) 525-1234
Rate: $
239
Deadline for Group Rate:
2010-02-26
Hotel Policy
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Registration Rate:
$1,495.00 Register by 02/26/10
$1,695.00 Register after 02/26/10
Cancellation Date: 4/3/10 (Cancellation fee is determined by date cancelled.)
Course Completed
Registration Policy
Continuing Education Credit:
ACPE:
0708-0000-10-013-L03-P (1.4 CEU)
Initial Release Date:
4/1/10
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 - 5:45 PM
Day 2: 8:00 AM - 4:00 PM
This course provides a detailed review of the legal and regulatory principles driving prescription drug labeling, and patient labeling in the United States, Canada and the European Union. It addresses postmarketing communication to consumers and healthcare professionals, as well as providing an overview of product liability and public health policy issues in the United States. Also covered will be the clinical content structuring and coding based on the SPL Clinical Information Model ¿SPL 2b¿ and its implications on writing labels.
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Who Should Attend:
Professionals who develop, maintain and/or utilize global drug labeling information, pharmaceutical regulatory and clinical managers with 2 - 5 years' experience, drug information specialists with 1 - 3 years' experience, senior research and development managers; drug safety associates; and marketing, medical affairs and project management staff are encouraged to attend.
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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:
• Interpret the regulatory principles guiding prescription drug labeling in the U.S., Canada, and the European Union
• Identify current FDA labeling initiatives such as USPI, Patient Information Sheet, National Council on Patient Information and Education (NCPIE), and principles of medication error prevention
• Describe the impact of labeling on advertising and promotion
• Summarize the main principles in the use and implementation of a Company Core Data Sheet (CIOMS III/V)
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Key Topics:
• Short History of Drug Labeling and the Law
• Prescription Drug Labeling: Content & Format
• New U.S. Labeling Guidances
• Populating the Safety Sections of the USPI ¿ Impact of FDA's Physician Labeling Rule and Safety Labeling Guidances
• Development & Implementation of Company Core Data Sheet: CIOMS III/V
• Understanding Labeling Changes from a Liability Perspective
• New Canadian Labeling Guidelines
• EU SmPC Guideline
• FDA/PhRMA Target Product Profile
• FDA Office of Drug Safety and Medication Errors
• Communicating with Patients: Labeling and Advertising
• Impact of Labeling on Advertising and Promotion
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Course Director(s):
Steven W Bass, PhD
Pharmaceutical Labeling Consultant
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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