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Essential Labeling Tools: Global Labeling for Medical Devices, Labeling Compliance Self Audits and Plain Language Writing for Labeling Professionals

Apr 8 2014 8:00AM - Apr 8 2014 4:00PM | Bethesda North Marriott Hotel and Conference Center 5701 Marinelli Road, North Bethesda, MD 20852 USA

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Overview 

7:00-8:00 am  Tutorial Registration

8:00-10:00am Global Labeling for Medical Devices
Barbara J. Fanelli, MBA,MS
Associate Vice President, Global Regulatory Affairs Labeling
Sanofi U.S. Inc

Gerrit-Jan Nijveldt, MSc
Senior Director, Global Regulatory Affairs Labeling
Sanofi U.S. Inc

Today, companies use their own interpretation of regulations and guidelines when creating labeling for devices due to in part the limited device regulations and guidelines compared to the ones available for drugs. The goal of creating corporate labeling for devices is to provide the required information to the affiliate in a clear and concise format. The country can modify their local labeling, according to their regulations. This process ensures globally harmonized labeling. During this portion of the tutorial, the following will be discussed:

  • - Use of a so-called Company Core Device Manual (CCDM)
  • - Use of comprehension studies for the instructions
  • - Support for the core labeling and its local implementation
  • - Examples of labeling change

10:00-10:30 am Refreshment Break

10:30-12:30 pm Plain Language Writing for Labeling Professionals
Kala L. Paul, MD
President
The Corvallis Group, LLC

Almost 100 million Americans read at or below the 8th grade reading level, effectively cutting them off from much of our current written medical communication material. This portion of the tutorial explores conceptual and practical issues in generating plain language consumer medical communications, with practice in writing and evaluating communications that are easy to read, understand, and use. 

  • - Discuss how plain language principles can help improve readability of patient material
  • - Explain how to generate or revise written material using plain language principles to increase readability
  • - Practice using plain language principles for written communication

12:30-2:00 Lunch

2:00-4:00 pm  Labeling Self Audits
Joseph McMillian
Principal Partner
Heartland Compliance Services LLC

This presentation is designed to educate labeling and marketing professionals on methods for conducting a self audit.  The audit processes discussed in this course are not specific to any country.  They are designed to be applicable to any country and process which employs pharmaceutical labeling.

Learning Objectives 

At the conclusion of this tutorial, participants should be able to:

  • Describe how creating corporate labeling for devices can provide the required information to the affiliate in a clear and concise format
  • Discuss how plain language principles can help improve readability of patient material
  • Identify methods for conducting a self audit

Unless otherwise disclosed, the statements made by speakers represent their own opinions and not necessarily those of the organization they represent, or that of the Drug Information Association. Speakers, agenda and CE information are subject to change without notice. Recording of any DIA educational material in any type of media is prohibited without prior written consent from DIA.

Participants with Disabilities:
Reasonable accommodations will be made available to persons with disabilities who attend an educational activity. Contact the DIA office in writing at least 15 days prior to event to indicate your needs.

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