[February 01, 2018]

2 Day Course: Combination Products Regulations - Drug and Device Combinations in the USA and EU (Opfikon-Glattbrugg, Switzerland - May 15-16, 2018) - ResearchAndMarkets.com

The "Combination Products Regulations: Drug and Device Combinations in the USA and EU" conference has been added to ResearchAndMarkets.com's offering.

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.

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 cmbination products
• Interfaces: Change Management and LCM
• Compliant safety reporting for combination products
• Documentation requirements and interfacing

• 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
• Lecture 2: Introduction to Drug/Device Regulations
• Lecture 3: CE Marking, 510 K and PMAs general Overview
• Lecture 4: Case Study 1 - Including a walkthrough of expected outcomes for all case study exercises

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
• Lecture 3: Case Study 2
• Lecture 4: Compliant safety reporting for combination products

For more information about this conference visit https://www.researchandmarkets.com/research/58rfz3/2_day_course?w=4

View source version on businesswire.com: http://www.businesswire.com/news/home/20180201006115/en/

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