Seminar · Chicago, Illinois
2-day In-person Seminar Global Medical Device Regulations - US, EU and Canada
Health · Medicine · Pharmaceuticals
Key numbers
- Editions on record
- 1first in 2014
About 2-day In-person Seminar Global Medical Device Regulations - US, EU and Canada
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
From our listing of this edition. Details may have changed since.
Editions
| Year | Dates | Where | Exhibitors | Visitors |
|---|---|---|---|---|
| 2014 | 4–5 Sep 2014 | Chicago Marriott Suites O'Hare Chicago, Illinois | — | — |
Past editions from the bvents archive (2008–2019) and organiser figures where they were published.
Questions
When is 2-day In-person Seminar Global Medical Device Regulations - US, EU and Canada?
The next dates haven't been confirmed. The last edition we have on record was 4–5 Sep 2014.
Where is it held?
The last edition we have was at Chicago Marriott Suites O'Hare, Chicago, Illinois.