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Overview: 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, and selection of development and product approval pathways. Course Outline: Day 1 – Agenda 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 2 – Agenda 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 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 Who Will Benefit: • Regulatory • professionals • working in the medical device field ABOUT SPEAKER – Dr. 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. Location: Denver, CO Date: July 31st & August 1st, 2014 Time: 9 AM to 5 PM Venue: WILL BE ANNOUNCED SOON Price: $1,295.00 Discount: Register now and save $200. (Early Bird) Until June20, Early Bird Price: $1,295.00 from June21 to July29, Regular Price: $1,495.00 Contact Information: Event Coordinator Phone: 1800 447 9407 Fax: 302-288-6884 Email: support@globalcompliancepanel.com Website: https://www.globalcompliancepanel.com Event Link: http://bit.ly/1jZDGkG LIVE CHAT SUPPORT - http://www.globalcompliancepanel.com/chat/client.php NetZealous LLC, DBA GlobalCompliancePanel, 161 Mission Falls Lane, Suite 216, Fremont, CA 94539, USA
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