Mon Jun 25, 9:00 AM - Tue Jun 26, 6:00 PM

Hilton Garden Inn O'Hare

2930 S. River Road Des Plaines, IL 60018, Chicago, IL 60018

Community: Upper West Side

Description

This seminar provides Professionals working in this area with: A thorough understanding of the complexities involved

Event Details

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 reportin

Premier Event Photos

People Attending

Event Feed

Also See other Events Listed in New York City

Trending Events

Find Events in New York City

Leave empty Dates for all upcoming Events

Upcoming Events at Upper West Side


Join My Community

212area.com would like to send you latest updates