Combination Products (Salt Lake City, Utah, United States - October 15-16, 2018)

  • ID: 4594488
  • Conference
  • Location: Salt Lake City, Utah, United States
  • 2 Days
  • NetZealous LLC
  • Conference Dates: October 15-16, 2018
UP TO OFF
until Sep 10th 2018
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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

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
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9:00 AM to 5:00 PM

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

Case Study 3

Wrap Up Of Day 2

Final Q&A & Summary Of 'Working Smart' With Combination Products

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  • Salma Michor Salma Michor,
    CEO & Principal Consultant ,
    Michor Consulting and Trade Services GmbH


    Salma Michor - PhD, MSc, MBA, CMgr, RAC - 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 technology; and an MBA from Open University, and has earned the RAC (EU), CQA and is a Chartered manager.

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  • Clinical Trial Managers
  • Medical Officers
  • Regulatory Affairs
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ADDRESS

Salt Lake City, Utah
United States

Venue to be announced shortly.

Note: Product cover images may vary from those shown
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