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Combination Products: A Comprehensive Overview of Premarket Opportunities and Postmarket Challenges!

Oct 28 2014 8:30AM - Oct 28 2014 4:30PM | Washington Marriott Wardman Park 2660 Woodley Road, NW, Washington, DC 20008 USA

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Overview 

An estimated 30% of all new healthcare products under development today are combination products and the global drug-device combination products market is expected to grow to $115B by 2019. In order to tackle the clinical problems of the future, combination products will be used to treat a wide range of diseases from heart attack and stroke to Alzheimer’s, cancer, diabetes and beyond! In fact, every area of medicine will benefit because we can potentially erase the damage of disease or injury not just stop it.

This tutorial will highlight the regulatory strategies needed to get products to market.  This tutorial will also look at change management concerns including changes, design changes, documentation and reporting. A case study of a fictitious product will also be utilized for practical application of all these elements.

Who Should Attend 

Pharmaceutical, academic and government senior-level professionals and decision-makers involved in:

  • Drug Development and R&D
  • Pharmaceutical and Medical Device Professionals
  • Regulatory, Clinical and Other Professionals Responsible for Developing Drug/Device Combinations
  • Regulatory Affairs Professionals

Learning Objectives 

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

  • Identify regulatory considerations that need to be made to ensure successful management of combination products
  • Discuss the impact of post-approval changes
  • Recognize changes that require a post-market submission
  • Discuss the challenges (engineering, biotechnical, clinical) in developing a combination product

Contact Information 

Printable Registration Form

Registration Questions
Toll Free 1.888.257.6457
Phone +1.215.6100
Fax +1.215.442.6199
Monday-Friday 8:30AM - 8:00PM ET
CustomerService@diahome.org

Agenda Details
Carrie Dunn, Content Lead
Phone +1.215.442.6181
Fax +1.215.442.6199
Carrie.Dunn@diahome.org

Event Logistics
Ellen Diegel, Event Planner
Phone +1.215.293.5810
Fax +1.215.442.6199
Ellen.Diegel@diahome.org

Instructor(s) 

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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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