Latest Guidelines for Combination Products Registration - 2017
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
- EU/US
The webinar will clarify the regulatory requirements of combination products and address life-cycle management
- Examining the regulatory requirements for drug device combinations in the case of a drug and a device and for integral products
Why should you Attend:
This is a complex area requiring experience in both the pharmaceutical/Biotech and the medical device sector.This webinar will examine the regulatory requirements for drug device combinations in the case of a drug and a device and for integral products.This webinar will cover the basic requirements of how to stay compliant.
Areas Covered in the Session:
Regulatory Requirements
- EU/US
- CE Marking
- 510 K and PMAs general Overview
- Documentation requirements for combination products EU/US
- Interfacing,Development,Quality,Regulatory
- Managing third parties and document control
- Vigilance and adverse event reporting
Who Will Benefit:
- Regulatory Affairs
- Medical Officers
Speaker and Presenter Information
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.
Event Type
Webcast
This event has no exhibitor/sponsor opportunities
When
Mon, Jul 10, 2017, 10:00am - 11:00am
PT
Cost
| General Admission: | $150.00 |
Website
Click here to visit event website
Organizer
NetZealous - Compliance4All
