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DIA Meeting on Combination Products

Nov 5 2013 7:00AM - Nov 5 2013 5:15PM | Embassy Suites Old Town Alexandria 1900 Diagonal Road, Alexandria, VA 22314 USA

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Overview 

Travel Once, Learn Twice and Save up to 35%
Register for both the DIA Meeting on Combination Products and the DIA Meeting on Personalized Medicines and Companion Diagnostics – and Save up to 35%.*
*You must register for both events at the same time. 
Price savings varies by registration fees


Advances in scientific knowledge and technology are driving growth and innovation for combination products and companion diagnostics, thereby enabling personalized therapies that:

  • target those patients most likely to benefit from treatment;
  • exclude those patients most likely to suffer harm; and
  • can be monitored during treatment for clinically significant changes.

This conference will provide a practical approach to development processes and regulations in these evolving landscapes. This one-day meeting will focus on combination products. DIA is hosting a related one-day meeting on personalized medicines and their companion diagnostics, November 6: DIA Meeting on Personalized Medicines and Companion Diagnostics

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 raise challenging policy, regulatory, and review management challenges. 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 day will focus on:

  • Innovation in Combination Products
  • Development Challenges, Preclinical and Clinical Data, and Human Factor Considerations for Combination Products
  • Infrastructure to Support Combination Products
  • Regulatory Developments

Who Should Attend 

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

  • drug development and R&D
  • pharmaceutical and medical device and diagnostics professionals
  • regulatory, clinical and other professionals responsible for developing drug/device combinations and companion diagnostics
  • 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 development and registration
  • Describe the differences between device and drug development processes and regulations
  • 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 

Travel Once, Learn Twice and Save up to 35%

Hotel & Travel 

The meeting will be held at the Embassy Suites Alexandria Old Town.
A limited number of rooms are available at the reduced rate shown below (rate is guaranteed until October 15, 2013, or until room block is filled).  Please note: In order to receive the reduce 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 or call+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 #13021.

Standard Room Rate $189
Rate includeds the following for all rooms booked using link or phone number noted above:

  • Complimentary meeting room wireless
  • Complimentary sleeping room wireless
  • Complimentary full hot breakfast
  • Complimentary evening reception

Hotel Address: 1900 Diagonal Road  Alexandria, VA 22314

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 

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
Melissa Buchanan, Content Lead
Phone +1.215.442.6158
Fax +1.215.442.6199
Melissa.Buchanan@diahome.org

Event Logistics
Benjamin Zaitz, Event Planner
Phone +1.215.293.5803
Fax +1.215.442.6199
Benjamin.Zaitz@diahome.org

Continuing Education 

Drug Information Association has been accredited as an Authorized Provider by the International Association for Continuing Education and Training (IACET), 1760 Old Meadow Road, Suite 500, McLean, VA 22102; (703) 506-3275.

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 this 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:

All participants must sign-in to record attendance at the program to receive a statement of credit. If attendance is not recorded, a participant will not be eligible to receive credit. No partial credit will be awarded. To request credit, complete the on-line credit request process through My Transcript at www.diahome.org. 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 Tuesday, November 19, 2013.

To view DIA’s Grievance Policy, please visit the CE page on DIA’s website at www.diahome.org/CE

Program Committee 

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Agenda  

Day 1 Tuesday, November 05, 2013

  • 7:30AM - 8:15AM

    Registration and Continental Breakfast
  • 8:15AM - 8:20AM

    Welcome and Opening Remarks

    Speaker(s):

    • Jennifer Paine, MS,RAC
      Worldwide Vice President of Quality, Regulatory and Compliance
      Ortho Clinical Diagnostic - Part of the Johnson & Johnson Family of Companies, United States
  • 8:20AM - 8:35AM

    Keynote Address

    Speaker(s):

    • Keynote Address
      David H. Dorsey
      Senior Director, Americas Head Global Regulatory Policy and Intelligence
      Janssen Research and Development, United States
  • 8:35AM - 9:00AM

    Combination Products State of the Union


    Session Chair(s):

    • Thinh X. Nguyen
      Director, OCP
      FDA, United States

    Combination Products State of the Union

  • 9:00AM - 10:30AM

    Development Challenges, Preclinical and Clinical Data and Human Factor Considerations for Combination Products


    Session Chair(s):

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

    Combination products increasingly incorporate both new technologies and novel marriages of drugs, biologicals, and medical devices. These products hold great promise, but bringing them to patients can challenge industry and regulators as they try to answer important questions about product safety and effectiveness. Nowhere is this more apparent than with combinations of drugs and biologicals with new delivery systems. This session will explore the challenges in developing combination products with a focus on drug/biological delivery systems, preclinical and clinical combination product data requirements, and human factor testing. FDA thought leaders will provide Agency perspectives, and industry experts will discuss their experiences in navigating these issues.

    Speaker(s):

    • Recent Development in Drug Delivery Systems
      Patricia Y. Love, MD,MBA
      Deputy Director, Office of Combination Products, OC
      FDA, United States
    • Recent Development in Drug Delivery Systems
      Richard D. McFarland
      Medical Officer, OCTGT - CBER
      FDA, United States
    • Human Factor Studies and Data Bridging Issues
      Valerie Fenster
      Senior Manager, Human Factors Engineering
      Amgen, United States
    • Industry Perspective on Combination Product Development
      Hortense Allison, MS
      Senior Manager of Regulatory Affairs
      Johnson & Johnson Vision Care, United States
    • Panel Discussion
      All Session Speakers, United States
  • 10:30AM - 11:00AM

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

    Combination Products CGMP


    Session Chair(s):

    • Steven B. Binion, PhD,MBA
      Director/Corporate Regulatory/Women's Health and Cancer
      Becton Dickinson, United States

    FDA issued the Current Good Manufacturing Practice (CGMP) Requirements for combination products to promote clarify which CGMP requirements apply when drugs, devices, and biological products are combined to create combination products. In addition, the rule sets forth a transparent and streamlined regulatory framework for organizations to use when demonstrating compliance with CGMP requirements for “single-entity” and “co-packaged” combination products. In this session, FDA will outline the final rule, discussing the requirement and expectations. Much of the session will be designed to provide an opportunity for audience participants to interact directly with CDER, CDRH, CBER and OCP.

    Speaker(s):

    • CGMP Final Rule
      John (Barr) Weiner, JD
      Associate Director for Policy and Product Classification Officer, OCP
      FDA, United States
    • Industry Perspectives
      Alex Wesolowski
      Vice President, Corporate RA
      Becton, Dickinson and Company, United States
    • Industry Perspectives
      Jeanmarie Sales
      Distinguished Reg Affairs Advisor
      Medtronic, Inc., United States
    • CDER, CDRH and CBER Perspectives
      Edward Patten, MS
      Office of Compliance and Biologics Quality, CBER
      FDA, United States
    • CDER, CDRH and CBER Perspectives
      Steven Hertz
      Consumer Safety Officer
      FDA, United States
    • CDER, CDRH and CBER Perspectives
      M. Isabel Tejero del Rio, MD,PhD
      Consumer Safety Officer, CDRH
      FDA, United States
    • CDER, CDRH and CBER Perspectives
      Melissa Torres
      Supervisory Biomedical Engineer, Office of Device Evaluation, CDRH
      FDA, United States
    • Panel Discussion
      All Session Speakers, United States
  • 12:30PM - 1:30PM

    Luncheon
  • 1:30PM - 3:00PM

    Global Development


    Session Chair(s):

    • Jennifer Paine, MS,RAC
      Worldwide Vice President of Quality, Regulatory and Compliance
      Ortho Clinical Diagnostic - Part of the Johnson & Johnson Family of Companies, United States

    As the market for global drug device combination products is expected to reach $30 billion by 2014, understanding international access challenges and regulatory changes is essential. In particular, changes to the Medical Device Directive in the EU will impact combination product oversight, and globally there are differences in how combination products are viewed by regulators. This session will provide overviews and insight into regulatory requirements and expectations of global markets.

    Speaker(s):

    • Bridging
      Erik Vollebregt, LLM
      Partner
      AXON Lawyers, Netherlands
    • Multi-market Access Challenges
      Elizabeth Baker
      Group Manager Licensing Division
      MHRA, United Kingdom
    • EU Regulatory Changes
      Paul C Brooks
      Senior Vice President
      Healthcare Solutions, United States
    • Panel Discussion
      All Session Speakers, United States
  • 3:00PM - 3:30PM

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

    Use of Mobile Medical Applications as Companions


    Session Chair(s):

    • Bradley Merrill Thompson, JD,MBA
      Partner
      Epstein, Becker and Green P.C., United States

    FDA has predicted that it will come out with a final guidance on mobile medical apps by October 1. This session will explore that final guidance, teasing apart exactly what types of apps in the pharmaceutical space will be regulated and which ones will not. To make the session more dynamic, we will explore several pre-prepared case studies that focus squarely on the difficult issues associated with applying that guidance to the pharmaceutical use cases. Three commentators will provocatively discuss the different possible interpretations of the guidance as applied to the case studies, and then we will ask the audience, using an electronic polling system, to vote to put the technology at issue into one of the following four categories: a.) Unregulated mobile app; b.) FDA regulated drug labeling; c.) FDA regulated medical device; or d.) FDA regulated medical device constituent part of a combination product. After seeing the audience poll, the panel will discuss whether they agree with the audience’s assessment.

    Speaker(s):

    • FDA Regulation of Mobile Apps
      Bradley Merrill Thompson, JD,MBA
      Partner
      Epstein, Becker and Green P.C., United States
    • Case Studies and Audience Interaction
      Mary Ann Smith
      DRA Policy Head of Medical Device and Combination Products
      Novartis, United States
    • Case Studies and Audience Interaction
      Azin Shahzamani
      Senior Director, Regulatory Affairs
      Genentech, A Member of the Roche Group, United States
    • Case Studies and Audience Interaction
      Jafar Shenasa
      Senior Director, Regulatory Affairs
      Proteus Digital Health, Inc., United States
  • 5:00PM - 5:15PM

    Closing Remarks

Registration Fees 

Member

Member Government
$415.00
Member Academia
$555.00
Member Standard
$925.00

Non-Member

NonMember Government
$590.00
NonMember Academia
$730.00
NonMember Standard
$1100.00
Group Discounts

Printable Registration Form

Group Discount

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.

To take advantage of this offer, please make a copy of the registration form for EACH of the four registrants and include the names of all other group registrants in the Group Discount section. 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.

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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