6-Hour Virtual Seminar

6-Hour Virtual Seminar on Combination Products

This webinar will examine the regulatory requirements for drug device combinations in the case of a drug and a device and for integral products, also this webinar will cover the basic requirements of how to stay compliant.

Salma Michor
Instructor:
Salma Michor
Date:
Thursday, May 20, 2021
Time:
08:00 AM PDT | 11:00 AM EDT
Duration:
6 Hours

More Trainings by this Expert   Product Id : 503770

Price Details
$545 Live
$745 Corporate Live
$595 Recorded
$945 Corporate Recorded
Combo Offers
Live + Recorded
$912 $1140 Live + Recorded
Corporate (Live + Recorded)
$1352 $1690 Corporate
(Live + Recorded)
Price Detail Options
Overview:

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: 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.

Agenda: 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

Who Will Benefit:
  • Regulatory Affairs
  • Medical Officers
  • Clinical Trial Managers


Speaker Profile
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,She 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.


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