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ACHIEVING REGULATORY APPROVAL OF COMBINATION PRODUCTS
Session Chair(s)
Shayesteh Fürst-Ladani, MBA, MS
CEO
SFL Regulatory Affairs & Scientific Communication, Switzerland
Speaker(s)
National Competent Authorities’ Role in Assessing Drug/Device Combinations
Waldo Weijers, PharmD
Medicines Evaluation Board, Netherlands
Secretary / Coordinator Consultation Procedures
Notified Body’s Role in Assessing Device/Drug Combinations
Theresa Jeary, MSc
Lloyds Register Quality Assurance (LRQA), United Kingdom
Head of Notified Body
Case Study: Drug Device Combination Product– Regulated as a device
Toni K. Joergensen
MDRAC GmbH, Switzerland
Founder and President
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