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Regulatory Information Management 2013

Apr 3 2013 8:15AM - Apr 4 2013 5:00PM | Baltimore Marriott Inner Harbor at Camden Yards 110 South Eutaw Street Baltimore, MD 21201-1608

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Overview 

Solutions to Your Regulatory Process

Modern computer and other scientific technologies have made it possible for drug researchers and developers to generate and analyze more data than ever before. In response to louder calls for patient safety, and the multiple review jurisdictions called into multinational or global clinical trials, such data are also subject to more (and more intense) scrutiny during regulatory review and approval than ever before. As a result, for the past several years, regulatory departments have been asked to do more than ever before.

The need to understand the regulatory requirements for filing, timelines, what products are approved in which markets is becoming a critical regulatory need for both industry and regulators. Effective regulatory information management processes and tools are needed to ensure the organization remains compliant with its product registrations.

The DIA Regulatory Affairs Special Interest Area Community and an expert program committee have developed this conference, which will feature plenary sessions on the latest trends and regulations. Sessions are separated into two tracks: a business-focused track and a technology-focused track. 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. 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 end with a Vendor Showcase.


This program has been developed by the Regulatory Affairs Community

Who Should Attend 

Professionals involved in:

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

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
  • Describe 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

Hotel & Travel 

Baltimore Marriott Inner Harbor at Camden Yards
A limited number of rooms are available at the reduced rate shown below (DIA rate is guaranteed until March 11, 2013, or until room block is filled). Attendees can click here to make their hotel reservations, or by calling +1.212.532.1660 or in the USA at 1.800.221.3531.  When making your hotel reservation by phone, please select option 1 for “Hotel Reservations,” inform the phone agent that it is a DIA event, and provide them with the date and title of the meeting. 

Please Note:  In order to receive the reduced room rate, hotel reservations must be made as noted above, and not directly with the hotel.

Standard Room Rate $149

Hotel Address: 110 South Eutaw Street, Baltimore, MD 21201

The most convenient airport is Baltimore Washington Airport and attendees should make both airline and hotel reservations as early as possible.

Contact Information 

Registration Questions
Marilyn Ginsberg, Customer Service Associate
Phone +1.215.442.6135
Fax +1.215.442.6199
Marilyn.Ginsberg@diahome.org

Agenda and Event Details
Melissa Matta, Content Lead
Phone +1.215.442.6158
Fax +1.215.442.6199
Melissa.Matta@diahome.org

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

Tabletop Exhibit Information
Jeff Korn, Exhibits Associate
Phone +1.215.442.6184
Fax +1.215.442.6199
Jeff.Korn@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.

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 1.1 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.

Continuing education credits are not available for the Plenary Session 9: Vendor Showcase.

CERTIFICATE PROGRAMS

These programs are part of DIA’s Certificate Program and are awarded the following:
• Clinical Research Certificate Program: 6 Elective Units
• Regulatory Affairs Certificate Program: 6 Elective Units

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

Name Credit Type Max Credits CEU
Regulatory Information Management 2013 IACET 10.75 1.100

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 DIA’s 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 DAY, DATE.

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

Program Committee 

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Agenda  

Day 1 Wednesday, April 03, 2013

  • 8:15AM - 8:30AM

    Welcome and Opening Remarks
  • 8:30AM - 9:15AM

    Plenary Session 1

    Speaker(s):

    • Rebuilding Regulatory Affairs from the Top Down
      Arthur A. Ciociola, PhD
      Vice President, Head of Global Regulatory Affairs
      Alcon Laboratories, Inc., United States
  • 9:15AM - 10:00AM

    Plenary Session 2

    Speaker(s):

    • How FDASIA is Shaping the Regulatory Environment
      James Lindsay Cobbs, RPh
      Associate Director, US Regulatory Affairs
      Johnson & Johnson PRD LLC, United States
  • 10:30AM - 12:00PM

    Session 3A: Business Track - Global Product Classification: Identifying Challenges in Registration & Approval


    Session Chair(s):

    • Kimberly Belsky, MS
      Executive Director, Policy and Communication, Global Regulatory Affairs
      Bausch + Lomb, United States

    Companies may seek to bring their products to new global markets during the initial approval process or post-approval process. Leveraging a US dossier may present unanticipated challenges since the classification of a product and dossier requirements may change in the target country or region. This session will explore the challenges of geographic expansion and provide points to consider when planning the regulatory strategy and potential roadblocks.

    Speaker(s):

    • Presenter
      Brooke Casselberry, MS
      Director, Regulatory Affairs
      Liquent, Inc., United States
    • Presenter
      Mary Jane Nehring, MBA
      Executive Director, International Regulatory Affairs
      Bausch + Lomb, United States
    • Presenter
      Lauren Quinn, JD
      Head of US Regulatory Affairs
      Novartis Consumer Health, Inc., United States
  • 10:30AM - 12:00PM

    Session 3B: Tools and Technology Track - Ensuring Global Readiness for the ISO IDMP Standards


    Session Chair(s):

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

    By 2016, XEVMPD will transition from the 39 fields currently required to more than 120 fields required by ISO IDMP. Additional supporting documents will be required to be submitted. The FDA and other Health Authorities will require submissions based on these standards. This session will cover the steps to ensure global readiness.

    Speaker(s):

    • Presenter
      John W. Kiser, MSc
      Senior Director, Regulatory Operations
      Abbvie, United States
    • Presenter
      Vada A. Perkins, BSN,MSc,RN
      Senior Regulatory Program Management Officer, OD, CBER
      FDA, United States
    • Presenter
      William Mandarino
      Associate Director, Global Regulatory Systems and Technology
      UCB, Inc., United States
  • 1:30PM - 3:00PM

    Session 4A: Business Track - Access and Transparency of Information for Regulated Industry and the Customer


    Session Chair(s):

    • No-image Linda F. Bowen, MS,RAC
      Head of US Regulatory Policy and Intelligence
      Sanofi, United States

    This session will provide an update on clinical trial transparency in the US and EU. Access to information and disclosure: FOIA Requests will be discussed from US and Canadian perspectives.

    Speaker(s):

    • Presenter
      João da Silva Duarte
      Regulatory Intelligence & Policy Manager
      H. Lundbeck A/S, France, France
    • Presenter
      Mary C. Speagle
      Executive Director, Canadian Regulatory Affairs
      OptumInsight, Canada
    • Presenter
      Marlene S. Bobka, MLS
      Vice President
      FOI Services Inc., United States
  • 1:30PM - 3:00PM

    Session 4B: Tools and Technology Track - Case Study: Prescription Labeling Alignment and Compliance in a Global Environment


    Session Chair(s):

    • Mauricha F. Marcussen, MBA
      Program Mgr, Reg Affairs, Global Labeling, Operations & Compliance, AbbVie
      Auditgraph, United States

    In this session, presenters will share the methodologies and processes used to maintain alignment across global labeling content in compliance with a Corporate Integrity Agreement (CIA).

    Speaker(s):

    • Presenter
      Antoinette Eber-Roe, RPh
      Director, Regulatory Affairs
      AbbVie, Inc., United States
    • Presenter
      Jeff Elderton
      CEO
      Pivotstream, LLC, United States
  • 3:30PM - 5:00PM

    Session 5A: Business Track - Using Compliance (Regulatory) Intelligence to Facilitate Regulatory Compliance


    Session Chair(s):

    • Anita Fenty, MSc
      Senior Manager, Regulatory Policy and Compliance
      Covance Inc., United States

    This session will emphasize that Compliance Intelligence (CI), although similar to regulatory intelligence, is a powerful tool that can be used to facilitate regulatory compliance thus allowing the user to be proactive rather than reactive.

    Speaker(s):

    • Presenter
      Ann Ferriter
      Office of Compliance, CDRH
      FDA, United States
    • Presenter
      Penny S. Levin
      Director Global Regulatory Intelligence and Policy
      Teva Pharmaceuticals, United States
    • Presenter
      Arpita N. Shah, PharmD,RPh
      Sr. Manager, Regulatory Intelligence and Policy
      Celgene Corporation, United States
  • 3:30PM - 5:00PM

    Session 5B: Tools and Technology Track - Structured Content Management


    Session Chair(s):

    • Sarah Powell, RAC
      Executive Director, Regulatory Affairs
      Liquent, A Parexel Company, United States

    This session will have presentations on: A Custom Database to Manage Key Regulatory Aspects of Investigator Initiated INDs/IDEs in an Academic Research Center, Deriving Business Value from Rules-driven Automated Assembly of Narratives: A Structured Content Management Success Story, and Comparison of CRT data in legacy vs. SDTM formats.

    Speaker(s):

    • Presenter
      Shankar Srinivasan, PhD
      Senior Regulatory Specialist; Office of Research Regulartory Support
      Mayo Clinic, United States
    • Presenter
      Christina Sacro
      Transparency Manager
      Sanofi, United States
    • Presenter
      Shifu Zhao, PhD
      FDA Commissioner's Fellow
      FDA, United States

Day 2 Thursday, April 04, 2013

  • 8:30AM - 10:00AM

    Session 6A: Business Track - Creating a Regulatory Intelligence Function: Challenges and Opportunities


    Session Chair(s):

    • Brian Michael Mayhew, MBA
      Director
      Novartis Pharmaceuticals Corporation, United States

    This session will provide a brief overview of the roles and responsibilities of regulatory intelligence functions (and differences at different sizes of companies). Presenters will explore the key challenges in establishing and maintaining regulatory intelligence functions and offer resolutions for companies to consider to successfully implement regulatory intelligence functions.

    Speaker(s):

    • Presenter
      João da Silva Duarte
      Regulatory Intelligence & Policy Manager
      H. Lundbeck A/S, France, France
    • Presenter
      Penny S. Levin
      Director Global Regulatory Intelligence and Policy
      Teva Pharmaceuticals, United States
  • 8:30AM - 10:00AM

    Session 6B: Tools and Technology Track - A Case Study of Global Regulatory Affairs Information Management (RIM)


    Session Chair(s):

    • Dominique E. Lagrave, PharmD,MSc
      Director, Regulatory Affairs Operations
      Dendreon Corporation, United States

    Traditional RIM systems have focused on the relatively narrow focus of regulatory submissions and related tracking activities. The growing number of factors contributing to a demand for more expansive RIM solutions will be discussed.

    Speaker(s):

    • Presenter
      Rachel Carle
      Sr. Director, Regulatory Operations
      Genzyme Corporation, United States
    • Presenter
      Meredith Sewell
      Director, Global Regulatory Publishing
      Allergan Inc., United States
    • Presenter
      Speakers Invited
      United States
  • 10:30AM - 12:00PM

    Session 7A: Business Track - Regulatory Intelligence Tools (Free and for Fee) to Create a Regulatory Strategy


    Session Chair(s):

    • Meredith E.S. Brown-Tuttle, RAC
      Regulatory Affairs
      Regulatorium, United States

    Every regulatory strategy is unique; however, the questions that need to be addressed for each regulatory strategy are typically similar. The session will ask relevant development questions, which are components of the strategy and then illustrate the use of regulatory intelligence tools.

    Speaker(s):

    • Presenter
      Linda F. Bowen, MS,RAC
      Head of US Regulatory Policy and Intelligence
      Sanofi, United States
    • Presenter
      Jacqueline M. Kline, PhD
      Senior Director Regulatory Affairs
      Eisai Inc., United States
  • 10:30AM - 12:00PM

    Session 7B: Tools and Technology Track - Regulatory Information Management (RIM): Concepts for Strategic Use of Regulatory Information


    Session Chair(s):

    • Sarah Powell, RAC
      Executive Director, Regulatory Affairs
      Liquent, A Parexel Company, United States

    Now, more than ever, it is critical for companies to have a strategy to ensure the right systems, data governance, and reporting processes, are in place so that regulatory information is readily accessible within the company, accurate, and suitable for transmission to regulatory authorities. This session will describe the benefits of Regulatory Information Management.

    Speaker(s):

    • Presenter
      Jennifer Ann LaFleur, MS
      Head of Dossier Management Office II, Regulatory Affairs Operations
      Boehringer Ingelheim Pharma Gmbh & Co. KG, Germany
    • Presenter
      Jake Doran
      IT Director, Global Regulatory Affairs & Quality Assurance
      Janssen Research & Development, United States
    • Presenter
      Steve Gens, MS
      Managing Partner
      Gens and Associates Inc., United States
  • 1:30PM - 3:00PM

    Session 8A: Business Track - Implications of Working with FDA under FDASIA: A Primer for Successful Planning, Submission, and Approval of Applications


    Session Chair(s):

    • Lisa A. Jenkins, PhD
      Vice President, Regulatory Strategy and Content Development
      Virtual Regulatory Solutions, United States

    In 2012, FDASIA (including PDUFA V, MDUFA III, and GDUFDA) was signed into law. This session describes and interprets the new provisions from an FDA and Industry perspective and makes strategic recommendations for multiple disciplines.

    Speaker(s):

    • Presenters
      Kimberly Belsky, MS
      Executive Director, Policy and Communication, Global Regulatory Affairs
      Bausch + Lomb, United States
    • Presenter
      Ronald I. Trust, PhD,MBA
      Executive Director, Regulatory Affairs
      Durata Therapeutics, Inc., United States
  • 1:30PM - 3:00PM

    Session 8B: Tools and Technology Track - Standardization of Electronic Drug Application Data: A Critical Factor in Improving the Effectiveness and Efficiency of the Regulatory Review Process


    Session Chair(s):

    • Dominique E. Lagrave, PharmD,MSc
      Director, Regulatory Affairs Operations
      Dendreon Corporation, United States

    Data standards are a critical factor in improving the overall effectiveness and efficiency of the regulatory review process. This session will provide an overview of FDA’s commitment to the use of open, consensus-based data standards that will facilitate the efficient review of regulatory submissions.

    Speaker(s):

    • Presenter
      Mary Ann Slack
      Deputy Director, Office of Planning and Informatics, CDER
      FDA, United States
    • Presenter
      Stephen E. Wilson, DrPH
      Director, Division of Biometrics III, Office of Translational Science, CDER
      FDA, United States
    • Presenter
      Mark A. Gray
      Director, Div of Data Management Services and Solutions, OBI, CDER
      FDA, United States
  • 3:30PM - 5:00PM

    Plenary Session 9 - Vendor Showcase


    Session Chair(s):

    • Dominique E. Lagrave, PharmD,MSc
      Director, Regulatory Affairs Operations
      Dendreon Corporation, United States

    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 and answer panel.

Exhibits  

The Regulatory Information Management 2013 conference 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:
April 3-4, 2013

Special Vendor Showcase: All exhibiting companies are encouraged to participate in the Vendor Showcase Q&A Discussion session on Thursday, April 4 - 3:30-5:00 PM. Contact Jeff.Korn@diahome.org or Melissa.Matta@diahome.org for more information.

Useful Links:

  • Adlib
  • CSC
  • Ennov Solutions, Inc.
  • EXTEDO, Inc.
  • i4i
  • INFOTEHNA, Inc.
  • LIQUENT, A PAREXEL Company
  • Tarius
  • Virtify, Inc

Registration Fees 

Member

Charitable Nonprofit/Academia Member
$745.00
Member Government
$595.00
Member Standard
$1490.00

Non-Member

Charitable Nonprofit/Academia Nonmember
$920.00
NonMember Government
$770.00
NonMember Standard
$1665.00
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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