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Regulatory Information Management 2014

Feb 25 2014 8:25AM - Feb 26 2014 4:00PM | Bethesda North Marriott Hotel and Conference Center 5701 Marinelli Road, North Bethesda, MD 20852 USA

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Overview 

With an increased focus on getting innovative therapies to market, ensuring patient safety and regulatory compliance with approved application information, organizations are challenged to operate with a global perspective. The ability to access and use information in the data-rich world of the BioPharma and Medical device industries is critical to success. Effective regulatory information management (RIM) processes and tools are needed to ensure organizations are effectively and efficiently developing new products and conducting life-cycle management while also remaining compliant with approved product registrations. This two-day annual conference will share strategies on interpreting the regulatory requirements for filing, best practices for managing information, and review of many new or changing regulatory requirements.

The DIA Regulatory Affairs Community and an expert program committee are developing this conference, which will feature plenary sessions on latest trends in the industry.

Sessions are separated into two tracks:

  • The Business Track will provide the opportunity to interact and share experiences related to processes for obtaining and managing regulatory information and the organizational impact as well as gain a greater understanding of key issues shaping the global regulatory environment.
  • The Technology Track will focus on standards related to submission of regulatory information, the tools necessary to effectively manage the information, and associated implementation experiences and lessons learned.

The conference will include a Vendor Showcase

Who Should Attend 

  • Clinical Research & Development/Clinical Supplies
  • eClinical
  • Global Project Managers
  • Information Technology
  • Regulatory Affairs/Operations
  • Regulatory Information Management
  • Regulatory, Medical, and Technical Writers

Learning Objectives 

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

  • Identify key business drivers for establishing a global regulatory information management system
  • Share industry best practices related to standards and processes needed for effective regulatory information management
  • Recognize the important role of regulatory intelligence in a regulatory information management strategy
  • Gain understanding of critical changes in the global regulatory environment

Special Offers 

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

Hotel & Travel 

Bethesda North Marriott Hotel & Conference Center

A limited number of rooms are available at the reduced rate shown below (rate is guaranteed until February 7, 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 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 #14005.

Standard Room Rate $159

Hotel Address: 5701 Marinelli Road North Bethesda, MD 20852

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

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

Tabletop Exhibit Information
Shannon Lewis, Exhibits Associate
Phone: +1.215.442.6149
Fax: +1.215.442.6199
Shannon.Lewis@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; +1.703.506.3275.

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 1.2 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:
• Regulatory Affairs Certificate Program: 8 Elective Units
For more information go to www.diahome.org/certificateprograms

Name Credit Type Max Credits CEU
Regulatory Information Management 2014 IACET 11.50 1.200

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 program, and complete the on-line 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 Wednesday, March 12, 2014.

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, February 25, 2014

  • 8:25AM - 8:30AM

    Welcome and Opening Remarks

    Speaker(s):

    • Sarah Powell, RAC
      Director, Regulatory Affairs
      Parexel International, United States
  • 8:30AM - 9:15AM

    Plenary Session 1: Managing Regulatory Effectiveness


    Session Chair(s):

    • Alison Maloney
      Head Regulatory Affairs
      Bayer Inc., Canada

    Successful regulatory outcomes require focused strategy and efficient processes. How do you achieve high quality regulatory dossiers, with optimal labeling while still remaining compliant with approved product registrations? This session will focus on achieving business strategy success through implementation of key performance indicators.

  • 9:15AM - 10:00AM

    Plenary Session 2: FDA Update on FDASIA


    Session Chair(s):

    • Jonca C. Bull, MD
      Director, Office of Minority Health, Office of the Commissioner
      FDA, United States

    The Food and Drug Administration Safety and Innovation Act (FDASIA), signed into law on July 9, 2012, expands the FDA’s authorities and strengthens the agency's ability to safeguard and advance public health. FDA will highlight developments around key pieces of FDASIA, including demographic subgroup inclusion and regulatory science, an increased focus on the patient voice in drug development, informing new initiatives such as breakthrough therapies, drug shortages, orphan drugs/rare diseases, and FDA efforts in advancing scientific initiatives. Time will be given for questions

  • 10:30AM - 12:00PM

    Session 3A: Business Track - Case Studies on Regulatory Information Management and Data Migration


    Session Chair(s):

    • Brooke Casselberry, MS
      Director, Regulatory Affairs
      Liquent Inc., A PAREXEL Company, United States

    This session will provide case studies on data migration and regulatory information managed over a number of projects. Lessons learned, successes, and skills essential for this type of endeavor will be discussed.

    Speaker(s):

    • Case Study: Regulatory Information Management & Data Migration
      Brooke Casselberry, MS
      Director, Regulatory Affairs
      Liquent Inc., A PAREXEL Company, United States
    • Case Studies on Regulatory Information Management and Data Migration
      Hans van Bruggen, MSc
      Senior Regulatory Affairs Scientist
      eCTDconsultancy B.V., Netherlands
    • Jason Moyer
      Director, Regulatory Information Management
      Merck & Company Inc., United States
  • 10:30AM - 12:00PM

    Session 3B: Tools and Technology Track - RIM System Improvement Life Cycle


    Session Chair(s):

    • Antonietta Falbo, MBA
      Director, Regulatory Information Management (RIM) Program Office
      Janssen Pharmaceuticals, Inc., United States

    Continuing to explore the difficulties in building and maintaining a robust RIM system, this session will present the results of a year-long project that focused on RAPID (Regulatory Affairs Product Information Database). Attendees will gain a deeper understand of the necessity of data integrity/quality, data monitoring and importance of defining discrete data entry and ownership roles as they relate to either implementing a new RIM System or updating an existing RIM program.

    Speaker(s):

    • The Rumba RIM System: (RAPID Reboot Part Deux)
      Meredith K Sewell
      Director, Global Regulatory Publishing
      Allergan Inc., United States
    • RIM Evolution and Future Vision
      John W. Kiser, MSc
      Senior Director, Regulatory Operations
      Abbvie Ltd., United States
  • 1:00PM - 2:30PM

    Session 4A: Business Track - Leveraging Regulatory Agency Reviews to Develop Regulatory Strategic Plans


    Session Chair(s):

    • Sarah Powell, RAC
      Director, Regulatory Affairs
      Parexel International, United States

    Increasingly regulatory agencies have been launching transparency initiatives to render their marketing application approval decision making process accessible to industry. In particular, FDA, the European Medicines Agency (EMA), the Japan Pharmaceuticals Medical Devices Agency (PMDA), and Health Canada (HC) reviews and assessments of marketing authorization submissions are publicly available. These reviews provide a wealth of information to all regulatory strategists e.g., on agencies’ challenges during their decision-making process, the prevailing regulatory “culture” or how the agencies integrate expert assessments in their decision-making process. A regulatory strategist may use these reviews as supporting evidence for global regulatory strategic planning, starting at inception of a global development project. A case study will be presented to demonstrate how the information contained in reviews of an approved ophthalmic products prepared by PMDA, US FDA and EMA can be used to build strategic knowledge on the regulatory interpretation of the data presented by the applicant. The case study will show examples of how the strategists can use these reviews to shape negotiation and contingency planning throughout development and beyond approval.

    Speaker(s):

    • Leveraging Regulatory Agency Reviews to Develop Regulatory Strategic Plans
      Isabelle B. Lefebvre, MSc,RAC
      Director, Ophthalmics, Rx and Development
      Valeant Pharmaceuticals NA, United States
    • Leveraging Regulatory Agency Reviews to Develop Regulatory Strategic Plans- Canada
      Mary C. Speagle
      Executive Director, Canadian Regulatory Affairs
      OptumInsight, Canada
  • 1:00PM - 2:30PM

    Session 4B: Tools and Technology Track - Business Case Development for a Global RIM Capability: Tools, Techniques, and ROI


    Session Chair(s):

    • Steve Gens, MS
      Managing Partner
      Gens and Associates Inc., United States

    How do you measure the business benefits of a comprehensive RIM capability from a global perspective? This session will cover both the quantitative and qualitative aspects of a business case along with the financial techniques to calculate business return on investment. Specific analysis techniques and category of benefits that require analysis will be reviewed.

    Speaker(s):

    • Enterprise RIM: Building the Business Case
      Steve Gens, MS
      Managing Partner
      Gens and Associates Inc., United States
    • Focusing your RIM Business Case for Approval
      James Hanly, MBA
      Director
      Bristol Myers Squibb, United States
    • Erik Hill, MBA,MSc
      Senior Director, Global Regulatory Affairs
      Eisai, Inc., United States
  • 3:00PM - 4:30PM

    Session 5A: Business Track - Integrating Regulatory Intelligence to Create a “Differentiating” Target Product Profile


    Session Chair(s):

    • Shanthi Sethuraman, PhD
      Director, Regulatory Center of Excellence, Global Regulatory Affairs-US
      Eli Lilly and Company, United States

    The Target Product Profile (TPP) is an FDA-recommended prescription drug product development tool. This is a powerful tool that can drive the development of the regulatory strategy and facilitate interactions with regulatory authorities and key stakeholders. Using this tool for internal project team interactions can help gain cross-functional alignment of clinical plans with desired/anticipated labeling claims and promotional messages throughout the drug development process. Leveraging regulatory intelligence is a critical imperative to the regulatory professional to differentiate a product based on approved drug labeling and promotional messages. The opportunities and challenges to integrate the right type and amount of regulatory information at the right times during drug development will be discussed during this session.

    Speaker(s):

    • Beginning with the End in Mind – Post-Approval Learnings Focused on the Premarket Period
      Tracy D. Rockney, JD
      Vice President, Regulatory Affairs, Global Labeling, Advertising and Promotion
      AbbVie, United States
    • Leveraging Regulatory Intelligence to Drive Insightful Target Product Profiles
      Robin Wojcieszek, RPh
      Senior Director, Global Regulatory Affairs-US
      Eli Lilly & Company, United States
  • 3:00PM - 4:30PM

    Session 5B: Tools and Technology Track - Preparing for IDMP


    Session Chair(s):

    • Andrew P. Marr, PhD
      Managing Director
      Marr Consultancy Ltd, United Kingdom

    The Identification of Medicinal Products (IDMP) standards in support of ICH M5 were published by the ISO in November 2012. The IDMP compliance challenge would be a game changer for the industry. It will not only change the compliance landscape but also result in a significant overall strategic growth for companies that truly adhere to these standards and organize their internal RIM processes around them. This session will include the FDA perspective.

    Speaker(s):

    • IDMP Implementation Activities: Status Update
      Vada A. Perkins, BSN,MSc,RN
      Chief, Business Operations Staff, Office of Medical Products and Tobacco, CBER
      FDA, United States
    • Getting Ready for IDMP
      Wim Cypers, MPharm
      Vice President, Regulatory SPU
      ArisGlobal, Belgium
    • Launching a Corporate Program to Ensure Readiness for the Identification of Medicinal Products (IDMP) Standards
      William Mandarino
      Associate Director, Global Regulatory Knowledge Management
      UCB, Inc., United States
  • 4:30PM - 5:30PM

    Networking Reception

Day 2 Wednesday, February 26, 2014

  • 8:30AM - 10:00AM

    Session 6A: Business Track - Actions to Streamline Data and Facilitate Global Submissions


    Session Chair(s):

    • Kimberly Belsky, MS
      Executive Director, Advertising, Labeling and Policy
      Valeant Pharmaceuticals , United States

    Regulatory teams across companies are facing extraordinary market conditions, constantly shifting regulations with multijurisdictional requirements, and increased pressure to register their products with reduced budgets and significant resource constraints. Keeping abreast of changes in the endless surge of pending legislation, not to mention newly enacted and existing regulations that affect your regulatory approvals, can be a daunting task. This session will review solutions to identify, monitor and track all potential regulatory changes, to anticipate risk opportunities and prepare for them with internal controls.

    Speaker(s):

    • Actions to Streamline Regulatory Data
      Ravi Varahalu
      Associate Director, Regulatory Operations
      Makrocare, United States
    • Leveraging Regulatory Information In a Complex Global Environment
      Thomas J. Noto
      Regulatory Operations Director
      GE Healthcare, United States
    • Actions to Streamline Data and Facilitate Global Submissions: Document Preparation and Management
      Tina Nyman
      Sunovion Pharmaceuticals Inc., United States
  • 8:30AM - 10:00AM

    Session 6B: Tools and Technology Track - Outsourcing Regulatory Activities


    Session Chair(s):

    • Dominique E. Lagrave, PharmD,MSc
      Principal Consultant
      Parexel International, United States

    Many companies are going through internal efficiency exercises to reduce cost and remain lean; all the while, increasing capacity to ensure volume targets can be met. This session will outline operational efficiency initiatives – outsourcing select regulatory operations activities (publishing and management of regulatory information). It will detail planning activities, vendor selection, onboarding, and training.

    Speaker(s):

    • Dominique E. Lagrave, PharmD,MSc
      Principal Consultant
      Parexel International, United States
    • Is Regulatory Outsourcing Right for You?
      Tony Catka, PhD
      Global Regulatory Intelligence Lead
      Accenture Accelerated R & D Services, United States
    • Submission Outsourcing - Stop working for it, make it work for you
      Kim S. Smith, MBA
      Pfizer Inc., United States
  • 10:30AM - 12:00PM

    Session 7A: Business Track - Intelligence from FDA Performance Metrics


    Session Chair(s):

    • Shanthi Sethuraman, PhD
      Director, Regulatory Center of Excellence, Global Regulatory Affairs-US
      Eli Lilly and Company, United States

    FDA publishes various reports and information in their website. This information, when mined appropriately can provide great insight on multiple fronts such division performance, opportunities for the various expedited pathways, postmarketing requirements/commitments, postmarketing supplements and more. This session will provide examples of analyses performed, information derived from the analyses and areas of opportunities to utilize this information to enable registration strategies.

    Speaker(s):

    • Presentation 1
      Michael Hay
      Executive Vice President, Sagient Product Director
      Sagient Research Systems, United States
    • Intelligence from FDA Performance Metrics
      Marija Popovic, PhD
      Regulatory Center of Excellence
      Eli Lilly & Co., United States
  • 10:30AM - 12:00PM

    Session 7B: Tools and Technology Track - Quality Benefits for Regulatory Information Management


    Session Chair(s):

    • Sarah Powell, RAC
      Director, Regulatory Affairs
      Parexel International, United States

    One of the most important and yet difficult enterprise processes to manage, is the release of commercial drug product into global markets. From a RIM perspective, this process involves the regulatory assessment of changes, registration management, submissions management, product information management and label management; and touches most regulatory functional areas. This session will focus on the prevention of product recall and quality data.

    Speaker(s):

    • Linking Regulatory Affairs to the Supply Chain to Ensure Compliant Product Release
      Kristofer Spahr
      Director of Regulatory Services
      TAKE Life Sciences, United States
    • Casey Overman
      Manager, IT
      Biogen Idec, United States
    • Nicholas Walzer
      Director Regulatory Business Operation
      Biogen Idec , United States
  • 1:00PM - 2:30PM

    Session 8A: Business Track - FDASIA Update


    Session Chair(s):

    • Kim M. Quaintance
      Head, US Regulatory Policy
      Bayer HealthCare Pharmaceuticals, United States

    This session will continue the update on the Food and Drug Administration Safety and Innovation Act (FDASIA). The focus will be on expedited approval pathways and breakthrough therapy designation, the NME review program, and structured benefit-risk including Patient Focused Drug Development. Panelists will discuss what was in FDASIA/PDUFA V, implementation, industry experience, and looking ahead.

    Speaker(s):

    • Program for Enhanced Review Transparency and Communication for NME NDAs and Original BLAs
      Kim M. Quaintance
      Head, US Regulatory Policy
      Bayer HealthCare Pharmaceuticals, United States
    • Expedited Development Programs
      Khyati N. Roberts, RPh
      Senior Director, Regulatory and Policy Intelligence
      Abbvie, United States
    • Structured Benefit/Risk & Patient Focused Drug Development
      Jayne C. Ware, MPH,MS
      Director, Global Regulatory Policy
      Merck & Co., Inc., United States
  • 1:00PM - 2:30PM

    Session 8B: Tools and Technology Track - US Module 1 Update and Implications


    Session Chair(s):

    • Dominique E. Lagrave, PharmD,MSc
      Principal Consultant
      Parexel International, United States

    This session will focus on the eCTD Module 1 specifications. This session will include an overview of the Module 1 administration and submission information.

    Speaker(s):

    • AdPromo eCTD Submissions: Considerations & Communication
      Douglas Kent
      Submission Lead
      Janssen - J&J Pharma, United States
    • eCTD Module 1 Update
      Mark A. Gray
      Director, Division of Data Management Services and Solutions, OBI, CDER
      FDA, United States
  • 3:00PM - 4:00PM

    Plenary Session 9: Vendor Showcase


    Session Chair(s):

    • Andrew P. Marr, PhD
      Managing Director
      Marr Consultancy Ltd, United Kingdom

    The RIM Vendor Showcase provides a fantastic opportunity for attendees to evaluate a number of currently available services and tools. During this session, a number of participating vendors will participate in an interactive question & answer panel.

Exhibits  

The Regulatory Information Management 2014 Conference offers interested companies the opportunity to exhibit with a tabletop display.

Tabletop registration for this conference is now CLOSED - space has SOLD OUT.

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 25-26, 2013

Useful Links

  • Accenture Life Sciences
  • Computer Science Corporation
  • DIA
  • INFOTEHNA Inc.
  • Lorenz International LLC
  • Mission3, Inc.
  • PAREXEL
  • Tarius
  • Veeva

Registration Fees 

Member

Charitable Nonprofit/Academia Member
$785.00
Member Government
$630.00
Member Standard
$1570.00

Non-Member

Charitable Nonprofit/Academia Nonmember
$1010.00
NonMember Government
$855.00
NonMember Standard
$1795.00
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

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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