Combination Products Seminar

Global Compliance Seminars

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.

Course Description

Course "Combination Products" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.

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.

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.
Who will benefit:
- Regulatory Affairs
- Medical Officers
- Clinical Trial Managers

Agenda:

Day 1 Schedule

Lecture 1 (90 Mins):

A high level overview to Combination Products

Including an interactive group session reviewing individual expectations

Lecture 2 (90 Mins):

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 (90 Mins):

CE Marking, 510 K and PMAs general Overview

US and EU

Life Cycle Management

Interfaces: Change Management
CTA applications
Annual reporting

Lecture 4 (90 Mins):

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(90 Mins):

Overview Combination product Regulation and CTD dossier requirments

EU and US (A comparative review)

Lecture 2(90 Mins):

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(90 Mins):

CASE STUDY 2

Lecture 4(90 Mins):

Compliant safety reporting for combination products

Taking into account your product's combined components when addressing adverse event reporting

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.

Credits Available

Course "Combination Products" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.

More Seminar Information

Global Compliance Panel
Summary	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.
Delivery Method	Seminar
Who Should Attend	Regulatory Affairs, Medical Officers, Clinical Trial Managers