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Marketing Pharmaceuticals 2015: Drug/Device Marketing in an Evolving Environment

Feb 18 2015 8:00AM - Feb 19 2015 5:00PM | Washington Marriott Wardman Park 2660 Woodley Road, NW, Washington, DC 20008 USA

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Overview 

Although Washington DC is experiencing inclement weather, the Marketing Pharmaceuticals Conference will proceed as scheduled.  We look forward to seeing everyone in DC. 

Tutorial:  February 17
OPDP/APLB and Compliance 101: A Primer

Conference: February 18-19 


 

This conference will explore drug and device marketing in an evolving environment while serving as a vital forum for all stakeholders involved with the marketing, advertising, and promotion of a wide range of health care products.  The importance of understanding the complex regulations regarding the marketing of pharmaceuticals, veterinary products, biologics, and medical devices has never been higher.  Recent actions by the FDA in response to rapidly expanding technologies have left organizations behind in their compliance efforts. 

To understand these recent enforcement actions, this conference features sessions led by those heavily involved in the regulation of marketing pharmaceuticals.  These sessions will offer insight into avoiding regulatory pitfalls while serving as a neutral forum to ask questions.   

Who Should Attend 

Professionals in pharmaceutical, biologics, veterinary drug and medical device companies involved in:

  • Compliance 
  • Corporate Communications
  • Legal 
  • Marketing 
  • Medical Information and Affairs 
  • Public Relations
  • Regulatory Affairs 
  • Senior Management

Learning Objectives 

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

  • Identify the trends reflected in the latest enforcement actions and policies issued by the FDA
  • Compare how other companies are complying with government regulatory requirements
  • Discuss best review and approval practices with industry colleagues
  • Assess novel promotional tactics trending in the pharmaceutical industry
  • Identify emerging issues in the oversight of marketing materials

Special Offers 

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 January 30, 2015, 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: Attendees can follow this link to make reservations online, or call toll free in the US 1.855.355.0302 or +1.212.532.1660.When calling please select option 1 for “Hotel Reservations,” and inform the phone agent that you are making a reservation for Event #15007.

Standard Room Rate $199

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


PLEASE READ
Warning: Unauthorized Solicitation

The most convenient airport is Washington Dulles International Airport (IAD) or the Ronald Regan Washington National Airport (DCA).

Contact Information 

Printable Registration Form

Registration Questions
Toll Free 1.888.257.6457
Phone +1.215.442.6100
Fax +1.215.442.6199
Monday-Friday 8:30AM-8:00PM ET
CustomerService@diahome.org

Agenda Details
Meredith Kaganovskiy, Content Lead
Phone +1.215.442.6117
Fax +1.215.442.6199
Meredith.Kaganovskiy@diahome.org

Event Logistics
Stephanie Ritter, Event Planner
Phone +1.215.442. 6149
Fax +1.215.442.6199
Stephanie.Ritter@diahome.org

Exhibit Details
Jessica Culp, Exhibit & Event Logistics Associate 
Phone +1.215.442. 6132
Fax +1.215.442.6199
Jessica.Culp@diahome.org 

Continuing Education 

DIA is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. This program and applicable tutorial are designated for up to 15.75 contact hours or 1.575 continuing education units (CEU’s) (.325 CEUs for the tutorial and 1.25 CEUs for the meeting).

Type of Activity: Knowledge

ACPE Credit Requests
ALL ACPE CREDIT REQUESTS MUST BE SUBMITTED THROU`GH DIA’S MY TRANSCRIPT BY FRIDAY, APRIL 3, 2015.
DIA is required by the Accreditation Council for Pharmacy Education (ACPE) to report pharmacy-requested CEUs through the CPE Monitor system. All ACPE-certified activity credit requests need to be submitted through DIA’s My Transcript within 45-days post activity. Pharmacists will need to provide their National Association of Boards of Pharmacy (NABP) e-Profile ID and date of birth (MMDD) to ensure the data is submitted to the ACPE and NABP properly. If you need to obtain your NABP e-Profile, please visit www.cpemonitor.net.

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

As an IACET Authorized Provider, DIA offers CEUs for its programs that qualify under the ANSI/IACET Standard. DIA is authorized by IACET to offer up to 1.6 CEUs (.3 CEUs for the tutorial and 1.3 CEUs for the meeting) 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:
• Regulatory Affairs Certificate Program: 8 Elective Units

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

CONTINUING EDUCATION CREDIT ALLOCATION
Tutorial:
• OPDP/APLB and Compliance 101: A Primer:
Pharmacy: 3.25 contact hours or .325 CEUs, 0286-0000-15-015-L04-P; IACET: .3 CEUs
Meeting:
IACET: 1.3 CEUs
Pharmacy:
• Day 1: 6.5 contact hours or .65 CEUs, 0286-0000-15-016-L04-P
• Day 2: 6 contact hours or .6 CEUs, 0286-0000-15-017-L04-P

Name Credit Type Max Credits CEU
OPDP/APLB and Compliance 101 ACPE 3.25 0.325
OPDP/APLB and Compliance 101 IACET 3.25 0.300
Marketing Pharmaceuticals 2015 ACPE 12.50 1.250
Marketing Pharmaceuticals 2015 IACET 12.50 1.300

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 each day of the meeting, and complete the on-line credit request process through My Transcript. To access My Transcript, please go to www.DIAGlobal.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, March 5, 2015.

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

Program Committee 

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Agenda  

Tutorials Tuesday, Feb 17, 2015

  • 1:30PM - 5:00PM

    OPDP/APLB and Compliance 101: A Primer

    If you are new, or relatively new, to OPDP and/or advertising/promotional compliance, this tutorial is for you!! The leaders will provide a strong introductory foundation for anyone working in our new regulatory environment. Whether you are a regulatory, legal, medical, or marketing professional, the information will be interesting, practical, and vital!

    To see more information on the Marketing Pharmaceuticals 2015 Workshop click here!

Day 1 Tuesday, Feb 17, 2015

  • 12:30PM - 1:30PM

    Tutorial Registration

Day 2 Wednesday, Feb 18, 2015

  • 7:30AM - 6:00PM

    Registration
  • 7:30AM - 8:30AM

    Continental Breakfast
  • 8:30AM - 8:45AM

    Welcome and Opening Remarks
  • 8:45AM - 10:30AM

    Session 1: Compliance Update


    Session Chair(s):

    • John T. Murray
      President
      Grayscale Compliance LLC, United States

    With the maturity of Corporate Integrity Agreements (CIAs) and compliance programs, many companies have ended or are near completion. The panel will discuss the key issues of managing completion of CIAs and what components are critical to remain after the CIA is complete. The panel will also discuss current trends in marketing compliance that are expected to impact drug promotion in the coming years.

    Speaker(s):

    • Speaker
      Kathleen Meriwether
      Principal, Assurance Services - Fraud Investigation and Dispute Services
      Ernst and Young, United States
    • Speaker
      Jeffrey E. Fleming
      VP Compliance North America
      AstraZeneca, United States
    • Speaker
      Joy Liu, JD
      Partner
      Ropes and Gray, United States
    • Speaker
      Wendy C. Goldstein
      Partner
      Cooley, LLP, United States
  • 10:30AM - 11:00AM

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

    Session 2: Leveraging Innovative Technologies Compliantly


    Session Chair(s):

    • Dale Cooke
      PhillyCooke Consulting , United States

    Consumers and health care professionals rely on the Internet and their mobile devices as essential tools for finding information about health care, medicine, and other treatment options. Makers of prescription products have been lagging behind in the uptake of these tools. This session provides the hands-on experience of some of the people who are leveraging YouTube and Twitter at the time and in the platform that people are using.

    Speaker(s):

    • Social Innovations in Healthcare
      Patricia MacWilliams
      Head of Healthcare Advertising Sales
      Google, United States
    • Speaker
      Craig Hashi, PhD, MBA
      Lead Pharma Strategist
      Twitter, United States
    • Legal Lessons: Effectively Leveraging Innovative Technologies
      Jennifer De Camara, JD
      Assistant General Counsel
      Johnson & Johnson, United States
    • Speaker
      Carla E. Brooks
      Associate Director, Promotional Regulatory Affairs
      AstraZeneca, United States
    • Panel Discussion
      All Session Speakers, United States
  • 12:30PM - 1:30PM

    Lunch
  • 1:30PM - 3:00PM

    Session 3: Scientific Exhange


    Session Chair(s):

    • Mark Gaydos
      VP & Head, US Specialty Care 2, North America & Global Regulatory Affairs  
      Sanofi US, United States

    Scientific exchange is a broadly defined concept that continues to be hotly debated and widely interpreted within the pharmaceutical industry. In recent years, activity in this area has intensified with important court decisions and increased pressure on FDA to clarify its position on the scope of activities and communications that fall within the scope of scientific exchange. Our session will examine these recent developments, including the evolving legal and regulatory landscape, as well a medical perspective given the key role this function has traditionally played in this area.

    Speaker(s):

    • Scientific Exchange: A Regulatory Overview
      Mark Gaydos
      VP & Head, US Specialty Care 2, North America & Global Regulatory Affairs  
      Sanofi US, United States
    • Changing Regulatory & Legal Landscape: What Does it Mean for Scientific Exchange?
      Torrey Cope, JD
      Partner
      Sidley Austin LLP, United States
    • DOJ’s Stance on Scientific Exchange
      Lisa C. Dykstra
      Partner
      Morgan Lewis, United States
    • Medical Affairs: The Science Behind Scientific Exchange
      Ira B Steinberg
      Vice President, Medical Affairs
      Boston Biomedical Pharma, Inc., United States
    • Panel Discussion
      All Session Speakers, United States
  • 3:00PM - 3:30PM

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

    Session 4: A Continuous Improvement Journey: Achieving Quality Excellence with Promotional Communications


    Session Chair(s):

    • No-image Glenn N. Byrd, MBA, RAC
      Senior Director, Promotional Regulatory Affairs
      AstraZeneca Specialty Care, United States

    We all strive to distribute high quality product advertising and promotional materials. This doesn’t simply happen organically or by accident. During this session we will explore how applying a quality system framework can help your organization consistently reach success with the distribution of promotional materials, while additionally improving employee engagement for key departments such as Regulatory, Legal, and Medical. Come and hear two companies who have put these systems in place, share their views on the power of quality systems and consistency, successes, and the lessons they learned along the way.

    Speaker(s):

    • Speaker
      Traci Campbell Paciulli, MBA
      Associate Director
      Merck & Co., United States
    • Speaker
      Jacob Nyman, MBA
      Director, Office of Promotion and Advertising Review
      Merck & Co., United States
    • Speaker
      Ann Connery, PhD
      Senior Director Quality Assurance Customer Information Quality
      Eli Lilly & Company, United States
    • A Continuous Improvement Journey: Achieving Quality Excellence with Promotional Communications
      Michele Sharp
      Senior Director, Global Regulatory Affairs - US
      Eli Lilly and Company, United States
    • Panel Discussion
      All Session Speakers, United States
  • 5:00PM - 6:00PM

    Reception

Day 3 Thursday, Feb 19, 2015

  • 7:00AM - 5:00PM

    Registration
  • 7:00AM - 8:00AM

    Continental Breakfast
  • 8:00AM - 9:30AM

    Session 5: Recent Enforcement Actions


    Session Chair(s):

    • No-image Wayne L. Pines
      President, Regulatory Services and Healthcare
      APCO Worldwide Inc., United States

    This session provides an overview of current issues, laws and guidances relevant to the promotion of prescription drugs, biologics and medical devices. Learn the latest on policy development, enforcement and FDA’s future initiatives.

    Speaker(s):

    • CDER Update
      Thomas W. Abrams, MBA, RPh
      Director, Office of Prescription Drug Promotion, CDER
      FDA, United States
    • 2014 CBER Update: Advertising & Promotional Labeling Compliance
      Dana Martin
      Consumer Safety Officer, CBER
      FDA, United States
    • Center for Devices and Radiological Health Drug Information Association Promotion and Advertising Update
      Deborah A. Wolf, JD
      Regulatory Counsel Office of Compliance, CDRH
      FDA, United States
    • CVM Update
      Thomas J Moskal, DVM
      Veterinary Medical Officer
      FDA/CVM, United States
    • Panel Discussion
      All Session Speakers, United States
  • 9:30AM - 10:00AM

    Refreshment Break
  • 10:00AM - 11:30AM

    Session 6: FDA Guidance Panel


    Session Chair(s):

    • Marci C. Kiester, PharmD
      Deputy Director, Office of Prescription Drug Promotion, OMP, CDER
      FDA, United States

    Are you aware of all of the new guidances regarding the promotion of prescription drugs, biologics and medical devices? In this session, FDA panelists will review the new guidances that describe FDA’s current thinking on important issues that have been raised by industry and FDA’s recommendations in these areas.

    Draft guidances to be discussed:

    • LATE BREAKING ADDITION: Brief Summary and Adequate Directions for Use: Disclosing Risk Information in Consumer-Directed Print Advertisements and Promotional Labeling for Human Prescription Drugs

    • Distributing Scientific and Medical Publications on Unapproved New Uses – Recommended Practices

    • Distributing Scientific and Medical Publications on Risk Information for Approved Prescription Drugs and Biological Products – Recommended Practices

    • Internet/Social Media Platforms: Correcting Independent Third-Party Misinformation About Prescription Drugs and Medical Devices

    • Internet/Social Media Platforms with Character Space Limitations – Presenting Risk and Benefit Information for Prescription Drugs and Medical Devices

    Speaker(s):

    • Panelists
      Julie Chronis, JD
      Regulatory Counsel, Office of Prescription Drug Promotion, CDER
      FDA, United States
    • Panelist
      Jean-Ah Kang, PharmD
      Special Assistant to the Director, Office of Prescription Drug Promotion, CDER
      FDA, United States
    • Distributing Scientific and Medical Publications on Unapproved New Uses--Recommended Practices
      Robyn C. Tyler, JD, PharmD
      Lead Regulatory Counsel, Office of Prescription Drug Promotion, CDER
      FDA, United States
    • Distributing Scientific and Medical Publications on Risk Information for Approved Prescription Drugs and Biological Products - Recommended Practices
      Kaylynn S. Yoon, JD
      Regulatory Counsel, CDER
      FDA, United States
  • 11:30AM - 12:30PM

    Lunch
  • 12:30PM - 1:00PM

    Session 7A: Substantial Evidence and Beyond


    Session Chair(s):

    • No-image Kristina Vlaovic, MPH
      Global Regulatory Franchise Head - Ophthalmology & Respiratory
      Genentech, A Member of the Roche Group, United States

    Substantial Evidence is the cornerstone of regulatory principles, however on a daily basis regulatory professionals are challenged to consider how to utilize other sources of data in a truthful and non-misleading manner. This interactive session will give the participants an opportunity to work through interesting case studies and discuss openly with their peers best practices and considerations for developing compliant materials.

    Speaker(s):

    • Speaker
      Sue E. Duvall, MBA, MPA, RN
      Senior Director International Regulatory Advertising and Promotion
      Abbvie, United States
    • Speaker
      Leah Palmer, PharmD
      Executive Director, Regulatory Promotion
      Amgen Inc., United States
    • Speaker
      Lynette Hopkinson, PharmD
      VP Commercial Regulatory Affairs, Global Regulatory Affairs
      Vertex Pharmaceuticals Incorporated, United States
  • 1:00PM - 1:30PM

    Session 7B: Marketing Follow-on Products


    Session Chair(s):

    • Kimberly Belsky, MS
      Executive Director, Regulatory Affairs, AdPromo, Labeling and Policy
      Valeant Pharmaceuticals, United States

    With the advent of pathways for the FDA approval of follow-on-biologics, the marketing of prescription drugs is likely to present new challenges for advertising and promotion and regulation. Moreover, the continued growing importance of generic drugs to the healthcare system continues to fuel the marketing of these drugs and the resulting regulatory challenges. The panel will discuss the unique issues in the promotion of follow on products, including generic drugs, follow on biologics, and even 505 (b)(2) products.

    Speaker(s):

    • A Review of Generic Drug Related Violation Letters
      Kimberly Belsky, MS
      Executive Director, Regulatory Affairs, AdPromo, Labeling and Policy
      Valeant Pharmaceuticals, United States
    • Opportunities for Differentiation Between Proprietary Brand and Generics/Biosimilars
      Tracy D. Rockney, JD
      Vice President, Regulatory Affairs, Global Labeling, Advertising and Promotion
      AbbVie Inc., United States
    • Perspectives on the Healthcare Environment - An Authentic Marketing Approach
      Robbie McCarthy
      Principal, Managing Director
      The Patient Experience Project, United States
  • 1:35PM - 2:05PM

    Session 8B: Disease Awareness: Education or Promotion?


    Session Chair(s):

    • No-image Glenn N. Byrd, MBA, RAC
      Senior Director, Promotional Regulatory Affairs
      AstraZeneca Specialty Care, United States

    The biotech and pharmaceutical industry is uniquely positioned to provide vital educational content to health care professionals and consumers. Disease awareness is an important component of ensuring promotion and protection of the Public Health, but it needs to be done right. Join us in examining the current trends in disease awareness/education as well as the trends in FDA enforcement and how to keep each activity — disease awareness and product promotion compliant.

    Speaker(s):

    • Speaker
      Sheetal Patel, PharmD
      Director, Regulatory Advertising and Promotion, US Pharma Group HCC
      Johnson & Johnson International, United States
    • Take it From a Fish: Social Media Disease Awareness Campaign
      Rosann Fisher
      Marketing Manager, CV Lipids Franchise
      AstraZeneca, United States
    • Speaker
      Rosemarie Carey
      Associate Director, Promotional Regulatory Affairs
      AstraZeneca Pharmaceuticals LP, United States
  • 2:05PM - 2:35PM

    Session 8A: Novel Promotional Tactics


    Session Chair(s):

    • No-image Lynette Hopkinson, PharmD
      VP Commercial Regulatory Affairs, Global Regulatory Affairs
      Vertex Pharmaceuticals Incorporated, United States

    Promotional Review Committees (PRCs) continue to be challenged by highly innovative and creative advertising and promotional tactics developed by the commercial organization. Commercially, the expectation of PRC is that activities or materials approved by the committee are going to resonate with the end user (patients, caregivers, healthcare providers or payors), be competitive, and ultimately result in increased product sales. This expectation needs to be managed in the context of the PRCs responsibility which is to review and approve advertising and promotion that is not only commercially compelling, but medically and scientifically accurate and in compliance with legal and regulatory requirements. How do PRCs strike the balance between innovation and compliance? A better understanding of new promotional channels could lead to better engagement and partnership with the business.

    Speaker(s):

    • Speaker
      Sandy Kerr, RPh
      Executive Director, Office of Promotion and Advertising Review
      Merck & Co., Inc., United States
    • Speaker
      Lynne B Minter
      Strategic Vendor Partnerships Leader, US Customer Engagement Evolution
      Merck, United States
    • Speaker
      Philomena McArthur, JD
      Senior Director, Regulatory Advertising and Promotion Pharmaceutical Group HCC
      Johnson & Johnson International, United States
  • 2:35PM - 3:00PM

    Refreshment Break
  • 3:00PM - 4:00PM

    Closing Session: Q&A with the FDA


    Session Chair(s):

    • No-image Janet "Lucy" Rose, MBA
      President
      Lucy Rose and Associates, LLC, United States

    Use this unique opportunity to bring your pressing questions for FDA to address in person. This session will attempt to answer any remaining questions from earlier sessions and to allow the audience to ask new questions to our FDA speakers.

    Speaker(s):

    • Thomas W. Abrams, MBA, RPh
      Director, Office of Prescription Drug Promotion, CDER
      FDA, United States
    • Julie Chronis, JD
      Regulatory Counsel, Office of Prescription Drug Promotion, CDER
      FDA, United States
    • Jean-Ah Kang, PharmD
      Special Assistant to the Director, Office of Prescription Drug Promotion, CDER
      FDA, United States
    • Robyn C. Tyler, JD, PharmD
      Lead Regulatory Counsel, Office of Prescription Drug Promotion, CDER
      FDA, United States
    • Kaylynn S. Yoon, JD
      Regulatory Counsel, CDER
      FDA, United States
    • Lisa L. Stockbridge, PhD
      Branch Chief, Advertising and Promotional Labeling Branch, CBER
      FDA, United States
    • Dorothy McAdams
      Supervisor VMO
      FDA/CMV, United States
    • Deborah A. Wolf, JD
      Regulatory Counsel Office of Compliance, CDRH
      FDA, United States

Exhibits  

The Marketing Pharmaceuticals 2015 meeting offers interested companies the opportunity to exhibit with a tabletop display.

Tabletop Fee: $1,500

Fee Includes:

  • One six-foot skirted table
  • One chair
  • Standard electricity

Each tabletop rental requires at least one registered attendee to staff the table. All tabletop staff must be registered conference attendees.

Tabletop Exhibit Dates:
February 18-19, 2014

Useful Links

  • Actelion Pharmaceuticals
  • DIA
  • Framework Solutions, Inc.
  • Genentech
  • Gilead Sciences
  • Opus Regulatory, Inc.
  • PharmaCloud
  • Porzio Life Sciences, LLC
  • Veeva Systems Inc.
  • Zinc Ahead

Registration Fees 

Member

Member Government
$630.00
Member Academia
$785.00
Member Standard
$1570.00

Non-Member

NonMember Government
$855.00
NonMember Academia
$1010.00
NonMember Standard
$1795.00
Registration Fees for Additional Offerings
OPDP/APLB and Compliance 101 - Tutorial #1 Rate
$405.00
Group Discounts\Registration

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.

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

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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