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Combination Product Premarket Considerations

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Overview 

Continuing Education credit or Certificate Program units are not available for Archived Webinars


FDA receives a large number of combination products for review as technological advances continue to merge product types. Because combination products involve components that would normally be regulated under different types of regulatory pathways, and frequently by different FDA Centers, they often raise difficult policy, regulatory, and review management challenges. Differences in regulatory pathways for each component can impact the regulatory processes for all aspects of product development and management, including premarket consideration. From what kind of product you have, to how it’s assigned, to application development and review, the premarket steps for combination products will be discussed during this webinar. Classification and assignment challenges will be reviewed. Case studies and scenarios will bring these steps together.


This archived webinar will be available for purchase through May 20, 2013.

Who Should Attend 

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

  • Drug Research and Development
  • Medical Device and Diagnostics
  • Development of Drug/Device Combinations and Companion Diagnostics
  • Regulatory Affairs
  • Clinical Research

Learning Objectives 

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

  • Identify the premarket steps for combination products
  • Discuss classification and assignment challenges of combination products

Contact Information 

For Questions About this Webinar
Carolyn Callahan
Phone +1.215.442.6194
Fax +1.215.442.6199
Carolyn.Callahan@diahome.org

Technical Requirements 

Click here for minimum system requirements.

Presenter(s) 

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Agenda  

Day 1 Tuesday, May 21, 2013

  • 11:00AM - 11:59PM

    Combination Product Premarket Considerations

    Speaker(s):

    • CMC Pre-Market Considerations for Combination Products Device/Biologics
      Kathy Lee
      Lead Interdisciplinary Scientist; Division of Therapeutic Proteins/OBP/OPS/CDER
      FDA, United States
    • Combination Product Premarket Considerations: Regulatory Case Studies
      Hina M. Pinto
      Regulatory Advisor, CDRH
      FDA, United States

Registration Fees 

Other Fees

Government (Full Time) Individual
$125.00
Charitable Nonprofit/Academia Individual
$175.00
Group Site
$799.00
Group Plus
$995.00

Member

Member Individual
$250.00

Non-Member

NonMember Individual
$295.00
Group Discounts

  • Group site registration is a license for ONE internet login allowing multiple viewers from one location.
  • Group Plus is a license for up to FIVE internet logins allowing one or more viewers at each login location.


CANCELLATIONS
No refunds will be provided in the event of a participant’s cancellation since all costs for this webinar have been prepaid by DIA. DIA reserves the right to modify or cancel programs and/or substitute presenters or panelists. DIA is not responsible for failure to deliver programs due to circumstances beyond its control.

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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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.

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