Webinar Duration: 60 minutes
RECORDED: Access recorded version only for one participant; unlimited viewing for 6 months (Access information will be emailed 24 hours after the completion of payment)
SPEAKER: Salma Michor
OVERVIEW:
During this introductory session, delegates will gain a complete guide to the status and impact of the latest guidelines for combination products. Examples (company specific) of combination products will also be discussed to gain insights into their variety and complexities.
EU/US
The webinar will clarify the regulatory requirements of combination products and address life-cycle management.
Examining the regulatory requirements for drug device combinations in the case of a drug and a device and for integral products
Why should you Attend: This is a complex area requiring experience in both the pharmaceutical/Biotech and the medical device sector. This webinar will examine the regulatory requirements for drug device combinations in the case of a drug and a device and for integral products. This webinar will cover the basic requirements of how to stay compliant.
Areas Covered in the Session:
– Regulatory Requirements
– EU/US
– CE Marking, 510 K and PMAs General Overview
– Documentation Requirements for Combination Products EU/US
– Interfacing, Development, Quality, Regulatory
– Managing Third Parties and Document Control
– Vigilance and Adverse Event Reporting
Who Will Benefit:
– Regulatory Affairs
– Medical Officers
SPEAKER PROFILE:
Salma Michor , PhD, MSc, MBA, CMgr, RAC is founder and CEO of Michor Consulting Schweiz GmbH, serving such clients as Johnson & Johnson, Novartis, Shire, Pfizer and Colgate Palmolive. Previously,She worked for Chiesi-Torrex, Wyeth Whitehall Export Croma Pharma GmbH. She teaches regulatory affairs and clinical strategies at the University of Krems, Austria, and is an independent expert to the European Commission. She holds a PhD in thermal process engineering and an MSc in food and biotechnology from the University of Applied Life Sciences in Vienna, Austria; an MSc from King’s College, University of London in food technology; and an MBA from Open University, and has earned the RAC (EU), CQA and is a Chartered manager.
