This seminar provides Professionals working in this area with
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.
A high level overview to Combination ProductsIncluding an interactive group session reviewing individual expectations
Introduction to Drug/Device RegulationsDuring 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. Regulatory Requirements for: US and EU
CE Marking, 510 K and PMAs general Overview
CASE STUDY 1 - Including a walkthrough of expected outcomes for all case study exercises
|1||2 Attendees||10% off|
|2||3 to 6 Attendees||20% off|
|3||7 to 10 Attendees||25% off|
|4||10+ Attendees||30% off|
To avail the above group discounts, all the participants should register by making a single payment
Call our representative TODAY on 1800 447 9407 to have your seats confirmed!
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 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.