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 products
- Documentation requirements and interfacing
Why you should attend
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
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
Time: 08:00 AM PDT | 11:00 AM EDT
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
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