6-Hour Virtual Seminar
6-Hour Virtual Seminar on Combination Products
08:00 AM PDT | 11:00 AM EDT
More Trainings by this Expert
Live: One Dial-in One Attendee
Corporate Live: Any number of participants
Recorded: Access recorded version, only for one participant unlimited viewing for 6 months ( Access information will be emailed 24 hours after the completion of live webinar)
Corporate Recorded: Access recorded version, Any number of participants unlimited viewing for 6 months ( Access information will be emailed 24 hours after the completion of live webinar)
This seminar provides Professionals working in this area with:
Why you should Attend:
- A thorough understanding of the complexities involved
- Covers all the relevant regulations and guidelines
- Gives real life examples of how to register and maintain various types of combination products
- Interfaces: Change Management and LCM
- Compliant safety reporting for combination products
- Documentation requirements and interfacing
Combination products are especially challenging to register and maintain since they consist of two or more regulated components covered by different and usually independent sets of regulations in both the EU and US and various other regions.
Delegates working in this area must keep abreast of current and new legislation in this complex area to ensure a good regulatory strategy and compliance of their products.
Documentation requirements and interfacing
Who Will Benefit:
- Documentation requirements for combination products EU
- Documentation requirements for combination products US
- Interfacing, development, quality, regulatory
- Managing third parties and document control
- Regulatory Affairs
- Medical Officers
- Clinical Trial Managers
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.