$1,285 – $3,875

Overview of Device Regulation - FDA (NTZ)

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Location

Embassy Suites Boston Logan Airport

207 Porter Street

Boston, MA 02128

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Event description

Description

This course provides a basic description of an FDA regulatory strategy for medical devices and explains the relationships between regulatory strategy and product development. It offers guidelines for developing successful strategies for medical devices, including definitions and classifications, elements of regulatory strategy, sources of regulatory intelligence, selection of development and product clearance/approval pathways.


Why should you attend:

This course provides a basic description of an FDA regulatory strategy for medical devices and explains the relationships between regulatory strategy and product development. It offers guidelines for developing successful strategies for medical devices, including definitions and classifications, elements of regulatory strategy, sources of regulatory intelligence, selection of development and product clearance/approval pathways.


Areas Covered in the Session:

  • Describe the elements impacting the definition and classification of medical devices
  • Determine the points to consider in the development of a regulatory strategy
  • Define the tools for regulatory strategy development
  • Recognize sources of regulatory and competitive intelligence
  • Identify the elements of a regulatory plan
  • Apply regulatory principles to develop a regulatory plan

Who Will Benefit:

  • Regulatory professionals working in the medical device field

Day 1 Schedule
Registration & Breakfast 8.30 am - 9.00 am

Lecture 1:


Overview of FDA Medical Device Regulation
9 am - 10.30 am
Break 10.30am - 11.00 am

Lecture 2:


Overview of FDA Medical Device 510(k) Premarket Notification Process
11.00 am - 12.30 pm
Lunch 12.30 pm - 1.30 pm

Lecture 3:


Overview of FDA Medical Device PreMarket Application Process
1.30 pm - 3.00 pm
Break 3.00 pm - 3.30 pm

Lecture 4:


Overview of FDA Device Manufacturing Issues
3.30 pm - 5.00 pm

Lecture 5:


Q & A
5.00 pm - 5.30 pm
Day 2 Schedule
Registration & Breakfast 8.30 am - 9.00 am

Lecture 1:


Overview of In Vitro Diagnostic Regulation
9 am - 10.30 am
Break 10.30am - 11.00 am

Lecture 2:


Overview of Biomedical Software Regulation
11.00 am - 12.30 pm
Lunch 12.30 pm - 1.30 pm

Lecture 3:


Overview of FDA Medical Device Post-Market Surveillance
1.30 pm - 3.00 pm
Break 3.00 pm - 3.30 pm

Lecture 4:


Overview of Device Regulatory Strategies
3.30 pm - 5.00 pm

Lecture 5:


Q & A
5.00 pm - 5.30 pm


Thomas E. Colonna

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 to his consulting activities, Dr. Colonna is the Director of the MS in Regulatory Science and MS in Food Safety Regulation programs at Johns Hopkins University.

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.



NO REFUNDS ON REGISTRATIONS ALLOWED

NO TRANSFER ON REGISTRATIONS ALLOWED

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Date and Time

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Embassy Suites Boston Logan Airport

207 Porter Street

Boston, MA 02128

View Map

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