How to Register and Maintain Several Types of Combination Products | Seminar 2018

GlobalCompliancePanel

Event

In Chicago (USA)

£ 1,194.81 VAT inc.

*Indicative price

Original amount in USD:

$ 1,495

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Description

  • Type

    Event

  • Location

    Chicago (USA)

  • Class hours

    9h

  • Duration

    2 Days

Compliant safety reporting for combination product

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

Facilities

Location

Start date

Chicago (USA)
See map
Hilton Garden Inn O'Hare 2930 S. River Road Des Plaines, IL 60018 Phone: +1 847-296-8900, 60018

Start date

On request

About this course

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.

Regulatory Affairs
Medical Officers
Clinical Trial Managers

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Reviews

Subjects

  • Change Management
  • Regulations
  • Medical
  • Health Management
  • Health Care Provider
  • Safety Management
  • FDA perspective
  • Regulatory
  • Compliance Management
  • Pharma

Teachers and trainers (1)

Salma Michor

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 t

Course programme

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

See related categories

How to Register and Maintain Several Types of Combination Products | Seminar 2018

£ 1,194.81 VAT inc.

*Indicative price

Original amount in USD:

$ 1,495

The best Medicine courses

See all

See all