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Global Regulatory Affairs: An Overview of Drugs and Biologics (incl. EU Clinical Trial Directive)
Course # t10
March 29 - March 30, 2010
Start - 8:00
Finish - 5:00
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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:
2010-02-11
Hotel Policy
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Registration Rate:
$1,495.00 Register by 02/11/10
$1,695.00 Register after 02/11/10
Cancellation Date: 3/19/10 (Cancellation fee is determined by date cancelled.)
Course Completed
Registration Policy
Continuing Education Credit:
ACPE:
0708-0000-10-010-L03-P (1.7 CEU)
Initial Release Date:
3/15/10
CBRN:
N/A
CME:
17 Hours of Category 1 Credit
VNA:
07-04-01 17 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 - 5:30 PM
Day 2: 8:00 AM - 5:00 PM
This course will provide a comprehensive overview of US/FDA, European, Canadian, Japanese and Rest-of-World (ROW)/emerging market regulations for drugs and biologics development from pre-clinical to post approval. Emphasis will be on FDA, European, and Canadian regulatory similarities and differences. Interactive sessions and workshops will identify and address regulatory obstacles faced by regulatory affairs professionals.
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Who Should Attend:
This course will be extremely valuable for those with 1-5 years of experience in regulatory affairs and those interested in understanding the regulatory road map for drugs and biologics development. This will include regulatory personnel, clinical/principal investigators, clinical research associates, study coordinators, medical program coordinators, clinical research managers, clinical affairs specialists, project managers, medical research associates, and clinical/medical monitors.
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Educational Objectives:
Upon completion of this course, participants should be able to:
- List the major similarities and differences between the regulatory agencies expectations and requirements from preclinical to post approval
- Describe effective ways of interacting with regulatory agencies
- Discuss regulatory agencies expectations when inspecting sponsor facilities, manufacturing processes and compliance
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Key Topics:
- US Regulations: IND, NDA, post approval and other activities
- EU Regulations: Clinical development, MAA, and post approval phases
- Canadian & Japanese Regulations
- ROW/Emerging Market Regulations
- Inspections
- Adverse Events Reporting
- International Conference on Harmonization (ICH)
- Interaction with Regulatory Agencies: Dos and Don'ts
- Promotional Compliance
- CMC Manufacturing Considerations
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Course Director(s):
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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