$1,719.95 – $9,346.95

Combination Products Regulations Course | USA and EU Seminar 2018

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Location

Hilton Zurich Airport

10 Hohenbühlstrasse

8152 Opfikon

Switzerland

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Event description

Description

Combination Products Regulations Course | USA and EU Seminar 2018

Course "Combination Products Regulations: Drug and Device Combinations in the USA and EU" 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
  • 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 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.

Sponsorship Program benefits for “Combination Products Regulations Course | USA and EU Seminar 2018

For More Information- https://www.globalcompliancepanel.com/control/sponsorship

Contact us today!

NetZealous LLC DBA GlobalCompliancePanel

john.robinson@globalcompliancepanel.com

support@globalcompliancepanel.com

Toll free: +1-800-447-9407

Phone: +1-510-584-9661

Website: http://www.globalcompliancepanel.com

Registration Link -

https://www.globalcompliancepanel.com/control/globalseminars/~product_id=901483SEMINAR?SEO-eventbrite-may18

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Date and Time

Location

Hilton Zurich Airport

10 Hohenbühlstrasse

8152 Opfikon

Switzerland

View Map

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