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DIA Meeting on Combination Products

Oct 29 2014 7:00AM - Oct 29 2014 5:00PM | Washington Marriott Wardman Park 2660 Woodley Road, NW, Washington, DC 20008 USA

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Tutorial:  October 28th - Combination Products: A Comprehensive Overview of Premarket Opportunities and Postmarket Challenges!
Meeting:  October 29th

Travel Once, Learn Twice and Save
Save when you register for both the DIA Meeting on Combination Products and the DIA Meeting on Companion Diagnostics
*You must register for both events at the same time.

Advances in scientific knowledge and technology are driving growth and innovation for combination products. Combination products are therapeutic and diagnostic products that combine drugs, devices, and/or biological products.

Because combination products involve components that would normally be regulated under different types of regulatory pathways, and frequently by different FDA Centers, they may raise challenging policy, regulatory, and review management issues. Differences in pathways ordinarily associated with each component can raise questions for all aspects of product development and management, including preclinical testing, clinical investigation, marketing applications, manufacturing and quality control, adverse event reporting, promotion and advertising, and post-approval modifications.

This conference will provide a practical approach to development processes and regulations in this evolving landscape. The day will focus on:

  • Innovations
  • Classification and Development Challenges
  • Pre- and Postmarket Issues
  • Regulatory Developments   

DIA is hosting a related one-day meeting on Companion Diagnostics on October 30th.

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 meeting, participants should be able to:

  • Discuss the US regulatory framework for drug/device combination products
  • Identify key challenges facing combination product developers as well as potential  options to address these challenges
  • Discuss the current status and emerging issues in the EU

Special Offers 

DIA Industry Members who register by
October 9, 2014, save $100!

Travel Once, Learn Twice and Save*
Final savings will appear in cart - see below for rate information

Group Discounts Available!
Register 3 and Get the 4th FREE!

Hotel & Travel 

Washington Marriott Wardman Park Hotel
A limited number of rooms are available at the reduced rate shown below (rate is guaranteed until October 13, 2014, or until room block is filled).  Please note: In order to receive the reduced room rate, hotel reservations must be made with Travel Planners and not directly with the hotel.  Contact information for Travel Planners is as follows: Attendees can follow this link to make their hotel reservations, or by calling  +1.212.532.1660 or 1.800.221.3531 in the U.S. When calling please select option 1 for “Hotel Reservations,” and inform the phone agent that you are making a reservation for Event #14016.

Standard Room Rate $239 (single or double occupancy)
$259 (triple occupancy)
$279 (quad occupancy)

Hotel Address: 2660 Woodly Road NW, Washington D.C., 20008 

Warning: Unauthorized Solicitation

The most convenient airport is Washington Dulles International Airport – IAD or Ronald Reagan Washington National Airport - DCA and attendees should make both airline and hotel reservations as early as possible

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

Agenda Details
Carrie Dunn, Content Lead
Phone +1.215.442.6181
Fax +1.215.442.6199

Event Logistics
Colleen Buckley, Event Planner
Phone +1.215.442.6108
Fax +1.215.442.6199

Ellen Diegel, Event Planner
Phone +
Fax +1.215.442.6199

Continuing Education 

Drug Information Association has been accredited as an Authorized Provider by the International Association for Continuing Education and Training (IACET).

As an IACET Authorized Provider, Drug Information Association offers CEUs for its programs that qualify under the ANSI/IACET Standard. Drug Information Association is authorized by IACET to offer .7 CEUs for the program. Participants must attend the entire program in order to be able to receive an IACET statement of credit. No partial credit will be awarded.

DIA’s Certificate Program
This program is part of DIA’s Certificate Program and is awarded the following:
• Clinical Research Certificate Program: 4 Elective Units
• Regulatory Affairs Certificate Program: 4 Elective Units

For more information go to www.diahome.org/certificateprograms

Name Credit Type Max Credits CEU
DIA Meeting on Combination Products IACET 7.00 0.700

Disclosure Policy:

It is DIA policy that anyone in a position to control the content of a continuing education activity must disclose to the program audience (1) any real or apparent conflict(s) of interest related to the content of their presentation and/or the educational activity, and (2) discussions of unlabeled or unapproved uses of drugs or medical devices. Disclosure statements will be included in the course materials.

Statement of Credit:

If you would like to receive a statement of credit, you must attend the program, sign in at the DIA registration desk, and complete the online credit request process through My Transcript. To access My Transcript, please go to www.diahome.org, select “Login to My DIA” and you will be prompted for your user ID and password. Select “My Transcript” (left side bar) and “Credit Request” to process your credit request. Participants will be able to download a statement of credit upon successful submission of the credit request. My Transcript will be available for credit requests on Thursday, November 13, 2014.

Program Committee 

Previous Next


Tutorials Tuesday, Oct 28, 2014

  • 8:30AM - 4:30PM

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

    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.

Day 1 Wednesday, Oct 29, 2014

  • 7:30AM - 8:00AM

    Registration and Continental Breakfast
  • 8:00AM - 8:10AM

    Welcome and Opening Remarks
  • 8:10AM - 8:30AM

    Combination Products State of the Union: Trends and New Developments

    Session Chair(s):

    • FDA Speaker Invited
      United States

    Combination Products State of the Union: Trends and New Developments

  • 8:30AM - 10:30AM

    Session 1: Premarket Considerations

    Session Chair(s):

    • Session Chair Invited
      United States

    Session 1: Premarket Considerations


    • Human Factors
      Speaker Invited
      United States
    • Redefining Focus
      Speaker Invited
      United States
    • Panel Discussion
      All Session Speakers, United States
  • 10:30AM - 11:00AM

    Refreshment Break
  • 11:00AM - 12:30PM

    Session 2: Postmarket Considerations

    Session Chair(s):

    • Steven B. Binion, PhD, MBA
      Director, Corporate Regulatory
      Becton Dickinson, United States

    Session 2: Postmarket Considerations


    • Design-control Considerations
      Speaker Invited
      United States
    • CGMP Panel Discussion
      Additional Speakers Invited
      United States
  • 12:30PM - 1:30PM

  • 1:30PM - 3:00PM

    Session 3: Collaboration in the Industry

    Session Chair(s):

    • James A. Boiani, JD, MS
      Senior Associate
      Epstein Becker Green, United States

    Session 3: Collaboration in the Industry


    • Successful Practices
      Speaker Invited
      United States
    • Challenges
      Speaker Invited
      United States
    • Panel Discussion
      All Session Speakers, United States
  • 3:00PM - 3:30PM

    Refreshment Break
  • 3:30PM - 5:00PM

    Session 4: Developing Products for Global Distribution

    Session Chair(s):

    • Session Chair Invited
      United States

    Session 4: Developing Products for Global Distribution


    • Manufacturing Compliance & Standards
      Speaker Invited
      United States
    • Harmonization
      Speaker Invited
      United States
    • Panel Discussion
      All Session Speakers, United States

Registration Fees 


Member Government
Member Academia
Member Standard
Member Standard (As of 10/10/2014)


NonMember Government
NonMember Academia
NonMember Standard
Registration Fees for Additional Offerings
Combination Products: A Comprehensive Overview - Standard Rate
Registration Information

Travel Once, Learn Twice Discount Information

Pricing for both the DIA Meeting on Combination Products and the DIA Meeting on Companion Diagnostics:
Early Bird Industry Member: $1136
Industry Member: $1256
Industry Non-Member: $1436

Non Profit/Academic Member: $785
Non Profit Academic Non-Member: $1010

Government Member: $630
Government Non-Member: $855

See how that compares to purchasing both meetings separately:
Industry Member: $1930
Industry Non-Member: $2380

Non Profit/Academic Member: $1160
Non Profit Academic Non-Member: $1610

Government Member: $870
Government Non-Member: $1320

Group Discounts

Register three individuals from the same company and receive complimentary registration for a fourth! All four individuals must register and prepay at the same time – no exceptions. DIA will apply the value of the lowest applicable fee to this complimentary registration; it does NOT include fees for optional events or DIA membership. You may substitute group participants of the same membership status at any time; however, administrative fees may be incurred.

To take advantage of this offer, please print a registration form for EACH of the four registrants from your company. Include the names of all four group registrants on each of the forms and return them together to DIA.

Group registration is not available online and does not apply to the already-discounted fees for government or charitable nonprofit/academia.

Register Online

CANCELLATION POLICY: All cancellations must be received in writing two weeks before
the start of the event. Administrative fee that will be withheld from refund amount:

  • Member or Nonmember = $200
  • Government or Academia or Nonprofit (Member or Nonmember) = $100
  • Tutorial (if applicable) = $50

Cancellations must be in writing and be received two weeks before the start of the event. Registrants who do not cancel two weeks before the start of the event and do not attend the event will be responsible for the full registration fee. Registrants are responsible for cancelling their own hotel and airline reservations. DIA reserves the right to alter the venue, if necessary. If an event is cancelled, DIA is not responsible for any airfare, hotel or other costs incurred by registrants.

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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