May 15, 2018 | 9:00 AM | Tuesday

Tue May 15, 9:00 AM - Wed May 16, 5:00 PM

Hilton Zurich Airport

Hohenbuhlstrasse 10, 8152 Opfikon-Glattbrugg, Switzerland. +41 44 828 50 50, Zurich, Sw 8152

Community: Clinton



Real life examples of how to register and maintain various types of combination products

Event Details

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.
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 requirments: EU and US (A comparative review)
Lecture 2:
Clarifying the regulatory requirements of combination product
Combination Products Regulations Course | USA & EU Seminar

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