Global Medical Device Regulations
Course "Global Medical Device Regulation" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant´s RAC recertification upon full completion.
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.
Why should you attend:
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, 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
Day 1 Schedule
Lecture 1: Overview of FDA Medical Device Regulation
Lecture 2: Overview of FDA Device Manufacturing Issues
Lecture 3: Overview of FDA Device Post-Market Surveillance
Lecture 4: Overview of Global Supply Chain Issues
Lecture 5: Q & A
Day 2 Schedule
Lecture 1: Overview of EU Medical Device Regulation
Lecture 2: Overview of Canada Medical Device Regulation
Lecture 3: Overview of EU and Canada Post-Market Surveillance
Lecture 4: Overview of Device Regulatory Strategies
Lecture 5: Q & A
Thomas E. Colonna
Founder, Biotech Consultant LLC
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.
Register now and save $200. (Early Bird)
Price: $1,295.00 (Seminar Fee for One Delegate)
Until July 10, Early Bird Price: $1,295.00 from July 11 to August 16, Regular Price: $1,495.00