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
Speaker
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.
Dr. Colonna provides consulting services in the scientific and regulatory aspects of a wide range of medical devices and biologics with particular expertise in the areas of in vitro diagnostics (ELISA-based, PCR-based, SNPs, microarrays, and pharmacogenomics), medical device software (including bioinformatics), and biotechnology-based products. Dr. Colonna's consulting clients range from Fortune 500 companies to small start-up companies located throughout the US, as well as, Canada, India, and Russia. Widely published in numerous fields, Dr. Colonna brings a unique multidisciplinary approach to problem solving.
Please fill in your name and email to receive the seminar agenda of this event.
Time: 8:30 AM to 5:30 PM
The agenda is available as PDF under downloads at the right side of the page.
Venue
The venue is not yet available for this event.
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Who Will Benefit:
- Regulatory professionals working in the medical device field
Venue
Embassy Suites Boston at Logan Airport207 Porter St.
Boston, MA 02128
