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HOW TO ADDRESS DIFFERENT REQUIREMENTS DEVELOPING COMBINATION PRODUCTS: THE CHALLENGES OF MANAGING TWO SETS OF RULES
Session Chair(s)
Josee Hansen
Senior Advisor
World Health Organization, Switzerland
Medicinal products & medical devices: the best of both worlds
Learning Objective : - Define differences between system for medicinal products and medical products - Define the best of both worlds to come to a risk based regulatory system, which would allow for timely introduction of innovative products at acceptable risks
Speaker(s)
Medicinal products & medical devices: the best of both worlds
Josee Hansen
World Health Organization, Switzerland
Senior Advisor
Human Factors Studies – Impact and Protocol Design
Alan J. Touch
Avodex Partners, United States
Chief Science Officer
The Differences between US Quality System Regulation and ISO Standards as well as FDA’s and Notified Bodies/Competent Authorities Expectation of Risk Assessment for Combination Products
Sean Creighton
FDA, United States
Medical Device National Expert
Consideration for Medical Device Companies Dealing with Regulators from Different Regulatory System (self-certification vs. pre-approval system)
Toni K. Joergensen
MDRAC GmbH, Switzerland
Founder and President
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