This course provides a basic description of global regulatory strategy for medical devices and explains the relationships between regulatory strategy and product development. It offers guidelines for developing successful global strategies for medical devices, including definitions and classifications worldwide, elements of regulatory strategy, sources of regulatory intelligence, and selection of development and product approval pathways.
Areas Covered in the Session:· Describe the elements impacting the definition and classification of medical devices globally
· Determine the points to consider in the development of a global regulatory strategy
· Define the tools for global regulatory strategy development
· Recognize sources of regulatory and competitive intelligence
· Identify the elements of a regulatory plan
· Apply global regulatory principles to develop a regulatory plan
Instructor/Speaker Profile:Dr. Thomas E. Colonna earned a bachelor of science in microbiology from the University of Sciences in Philadelphia (formerly the Philadelphia College of Pharmacy and Science), a Ph.D. in molecular biology from the Johns Hopkins University, and a law degree from the Georgetown University Law Center. In addition, Dr. Colonna holds academic appointments at Johns Hopkins University and the University of Sciences in Philadelphia.
Date, Venue and Price:
Location: Chicago, IL
Date: September 4th & 5th, 2014
Time: 9am to 5pm
Venue: Courtyard Chicago O'Hare
Address: 2950 S. River Road Des Plaines Illinois 60018 USA
Price: $1295.00
Discount: Register now and save $200. (Early Bird)
Until August 08, Early Bird Price: $1,295.00,
From August 09 to September 02, Regular Price: $1,495.00
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