Seminar on Combination Products Regulations: Drug and Device Combinations in the USA and EU training seminars presented by Global Compliance Panel register now on FindaSeminar.com

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Seminar on Combination Products Regulations: Drug and Device Combinations in the USA and EU  

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By:

Global Compliance Panel   

For:

Regulatory Affairs, Medical Officers, Clinical Trial Managers

Cost:   

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Seminar Summary:

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Training Course Syllabus:


Overview:

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 of their products.

Areas Covered in the Session:

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.

Agenda:

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 requirments: 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 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


Speaker:

Salma Michor
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.

Seminar Summary:

 (see full course description)

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