10 Hohenbühlstrasse8152 OpfikonSwitzerland, 10 Hohenbühlstrasse

Opfikon,

Opfikon,

Switzerland,

ZIP: 8152

Phone:

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
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 with their products.
Areas Covered in the Session:
Documentation requirements and interfacing
Documentation requirements for combination products EU
Documentation requirements for combination products the US
Interfacing, development, quality, regulatory
Managing third parties and document control.
Who Will Benefit:
Regulatory Affairs
Medical Officers
Clinical Trial Managers

Day 1 Schedule
Lecture 1:
A high-level overview to Combination Products
Including an interactive group session reviewing individual expectations
Lecture 2:
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
Lecture 3:
CE Marking, 510 K, and PMAs general Overview
US and EU
Life Cycle Management
Interfaces: Change Management
CTA applications
Annual reporting
Lecture 4:
CASE STUDY 1 - Including a walkthrough of expected outcomes for all case study exercises
Wrap up of day 1 & Q&A's



Day 2 Schedule
Lecture 1:
Overview Combination product Regulation and CTD dossier requirements: EU and US (A comparative review)
Lecture 2:
Clarifying the regulatory requirements of combination products and addressing life-cycle management
Examining the regulatory requirements for drug-device combinations in the case of a drug and a device and for integral products
Annual reports
Case studies
Lecture 3:
CASE STUDY 2
Lecture 4:
Compliant safety reporting for combination products
Taking into account your product's combined components when addressing adverse event reporting
Documentation requirements and interfacing
Documentation requirements for combination products EU
Documentation requirements for combination products the US
Interfacing, development, quality, regulatory
Managing third parties and document control.
CASE STUDY 3
Wrap up of day 2
Final Q&A & Summary of 'working smart' with Combination Products



Salma Michor
Ph.D., 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.


Please contact the event manager Marilyn (marilyn.b.turner(at)nyeventslist.com ) below for:
- Discounts for 5 or more participants.
- Require a price quotation.
- Require to pay by wire transfer or PayPal
- Invitation letter for visa applications

NO REFUNDS ALLOWED ON REGISTRATIONS
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