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 Products
Including an interactive group session reviewing individual expectations
Introduction to Drug/Device Regulations
During 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 exercisesWrap up of day 1 & Q&A's
Overview Combination product Regulation and CTD dossier requirments:
EU and US (A comparative review)
Clarifying the regulatory requirements of combination products and addressing life-cycle management
CASE STUDY 2
Compliant safety reporting for combination products
Wrap up of day 2
Final Q&A & Summary of 'working smart' with Combination Products
We facilitate registration by P.O/Checks!
Complete your registration in just a few easy steps
Please just download, fill out the registration form and send it to us either by email to email@example.com or just fax us at 302 288 6884.
Once the form is received, an invoice will be generated and sent back to your fax number.
Following this just send us your purchase order by fax at 302 288 6884
In case you wish to register by using check, please make a check to NetZealous LLC DBA GlobalCompliancePanel.com and mail it to the below address.NetZealous LLC,
Please call any of our representatives on 1800 447 9407 to help you completed the transfer.
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 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.