DESCRIPTION This seminar provides Professionals working in this area with -A thorough understanding of the complexities involved -All the relevant regulations and guidelines -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

Date : 27th November 2017 to 28th November 2017

Place : Switzerland, Opfikon

Website :https://www.eventbrite.com/e/combination-products-regulations-drug-and-device-combinations-in-the-usa-and-eu-ntz-tickets-38347536514?aff=NDT

Contact Person:Paula Edwards

Description:

DESCRIPTION This seminar provides Professionals working in this area with -A thorough understanding of the complexities involved -All the relevant regulations and guidelines -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

DESCRIPTION This seminar provides Professionals working in this area with -A thorough understanding of the complexities involved -All the relevant regulations and guidelines -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 will be held in Opfikon,Switzerland on date 2017-11-28

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Deadline for abstracts/proposals : 27th November 2017

Keynote Speakers : Salma Michor PhD, MSc, MBA, CMgr, RAC Salma Michor 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

Conference Highlights :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.

Venue :8152 Opfikon, Switzerland

Check the event website for more details.