Combination Products (Chicago, IL, United States - June 25-26, 2018)

  • ID: 4535535
  • Conference
  • Location: Chicago, IL, United States
  • 2 Days
  • NetZealous LLC
  • Conference Dates: June 25-26, 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

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
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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

Hilton Garden Inn Chicago OHare Airport
2930 S River Rd
Des Plaines
Chicago, IL
60018
United States


DIRECTIONS

From O'Hare International Airport:
10000 W O'Hare Ave, Chicago, IL 60666.

Head southwest on I-190 W (141 ft.)

Take the exit toward Bessie Coleman Dr-
(0.4 mi.)

Use the right 2 lanes to turn right onto Bessie Coleman Dr-
(0.2 mi.)

Use the right lane to take the Interstate 190 ramp to Interstate 90/Chicago/Interstate 294-
(0.2 mi.)

Merge onto I-190 E-
(1.4 mi.)

Keep right to continue on Exit 1A, follow signs for North River Road and merge onto Des Plaines River Rd/N River Rd-
(Continue to follow N River Rd.)

Destination will be on the left-
(1.6 mi.)

Hilton Garden Inn Chicago OHare Airport-
2930 S River Rd, Des Plaines, IL 60018.

Note: Product cover images may vary from those shown
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