2-day In-person Seminar Global Medical Device Regulations - US, EU and Canada 2014

This course provides an overview of international medical device regulations. Beginning with a discussion of the similarity of global requirements, including both voluntary and mandatory standards and directives, and progressing to in-depth analyses of market specific requirements, the course provides the student with resources to meet the regulatory requirements for the largest world markets. Country-specific regulatory requirements for Canada, EU, and US are included.

Course Outline/Agenda:
Day One Outline:
8.30 am to 9.00 am Registration & Breakfast
9 am to 10.30 am Overview of FDA Medical Device Regulation
10.30 to 11.00 am Tea break
11.00 am to 12.30 pm Overview of FDA Device Manufacturing Issues
12.30 pm to 1.30 pm Lunch break
1.30 pm to 3.00 pm Overview of FDA Device Post-Market Surveillance
3.00 pm to 3.30 pm Tea Break
3.30 pm to 5.00 pm Overview of Global Supply Chain Issues
5.00 pm to 5.30 pm Q & A

Day Two Outline:
8.30 am - 9.00 am Registration & Breakfast
9 am to 10.30 am Overview of EU Medical Device Regulation
10.30 to 11.00 am Tea break
11.00 am to 12.30 pm Overview of Canada Medical Device Regulation
12.30 pm to 1.30 pm Lunch break
1.30 pm to 3.00 pm Overview of EU and Canada Post-Market Surveillance
3.00 pm to 3.30 pm Tea Break
3.30 pm to 5.00 pm Overview of Device Regulatory Strategies
5.00 pm to 5.30 pm Q & A

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.
Dr. Colonna provides consulting services in the scientific and regulatory asp