Overview
This seminar provides Professionals working in this area with:
- 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 productsÂ
- Documentation requirements and interfacing
Why you should attend
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.
Who Will Benefit
- Regulatory Affairs
- Medical Officers
- Clinical Trial Managers
Agenda
Documentation requirements and interfacing
- Documentation requirements for combination products EU
- Documentation requirements for combination products US
- Interfacing, development, quality, regulatory
- Managing third parties and document control
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, Michor 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.
