FOUR-PART WEBINAR SERIES The Future of SPL: What’s Next? Webinar Series January 24, 2012 January 31, 2012 February 14, 2012 February 21, 2012

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SERIES MODERATOR THERESA BRUNONE Assistant Director Global Regulatory Affairs - Labeling GlaxoSmithKline

FEATURED TOPICS

• The PILLBOX Initiative • Opportunities and Challenges for Assessing Adverse Events and Warnings with SPL • The Present and Future of SPL: Uses of SPL by the Drug Compendia • SPL Use in the Life Sciences Industry

Worldwide Headquarters Drug Information Association, Inc. 800 Enterprise Road, Suite 200 Horsham, PA 19044, USA Regional Offices Basel, Switzerland Tokyo, Japan Mumbai, India Beijing, China

INDIVIDUAL MEMBER $250 • GROUP SITE $799 GROUP PLUS $995 This four-part webinar series will discuss the future of Structured Product Labeling (SPL). Join industry, vendors, and the standards community to share ideas and explore the future possibilities and downstream uses of SPL. WHO SHOULD ATTEND Professionals interested in downstream uses of SPL data who work in the areas of: • Pharmaceuticals • Brand • Generics • Over-the-counter • Biotechnology • Vaccines • Homeopathic medicines • Academic health centers • Clinical data management • Regulatory affairs • Manufacturing: drug substance, drug product, packaging • Document management • Information management • Information technology • Dictionaries/Data standards • Medical gas • Animal health

WEBINAR WEBINAR SCHEDULE AND DESCRIPTIONS

„ PART 2(CONTINUED)

„ PART 1WEBINAR #12204 JANUARY 24, 2012

LEARNING OBJECTIVES At the conclusion of this webinar, participants should be able to: • Discuss applied uses of SPL data in academic and clinical settings • Describe how SPL is being used in the specified fields in the product identification sections and the more textual fields of the content of labeling: 1) within electronic health records 2) as a support to patient safety system, and 3) a dataset for academic analysis

The PILLBOX Initiative—Present and Future MODERATOR DRAGAN OBRADOVICH Regulatory Project Manager Abbott Laboratories PRESENTER DAVID S. HALE Technical Information Specialist National Library of Medicine, NIH/HHS

„ PART 3WEBINAR #12207 FEBRUARY 14, 2012 The Present and Future of SPL: Uses of SPL

The PILLBOX Initiative is a program for the production of standardized high-resolution images of solid oral dose medicines (OTC and Rx). The program seeks to promote the utilization of the SPLIMAGE element of the Food and Drug Administration (FDA) Structured Product Label (SPL) through development and use of imaging standards and methodologies. This initiative is an important element of ongoing efforts to enhance patient safety, reduce adverse drug events, and improve the quality and availability of drug information.

by the Drug Compendia PRESENTER Drug Compendia Members ANNE JOHNSTON Senior Director Medco Health Solutions, Inc. PANELISTS KAY MORGAN SVP Drug Products and Industry Standards Elsevier/Gold Standard

LEARNING OBJECTIVES At the conclusion of this webinar, participants should be able to: • Discuss the PILLBOX initiative • Discuss how this initiative can enhance patient safety, reduce adverse drug events, and improve the quality and availability of drug information safety assessment

TERRI MEREDITH Director of Clinical Vocabularies Cerner Multum JULIE SUKO, PharmD Director, Editorial Content Services FDB (First Databank, Inc.)

„ PART 2WEBINAR #12205 JANUARY 31, 2012 Opportunities and Challenges for Assessing Adverse

PATRICIA MILAZZO, RPh Director - Drug File Content Wolters Kluwer Health

Events and Warnings with SPL MODERATOR MARCIA D. HOWARD, PhD Senior Director, Regulatory and Scientific Affairs Consumer Healthcare Products Association

PRESENTER LONNIE D. SMITH Policy Analyst, Data Standards Council and Office of Critical Path Programs, Office of the Commissioner FDA

PRESENTER JON D. DUKE, MD, MS Research Scientist, Medical Informatics, Regenstrief Institute Assistant Professor of Medicine, Indiana University School of Medicine Adjunct Professor of Informatics, IU School of Informatics

Drug Company Panelists JACQUELYN D. MOHNS Manager, Global Labeling Operations Bristol-Myers Squibb VIRGINIA HOGAN Associate Director, Regulatory Affairs, Labeling Teva Pharmaceuticals

Part 2 of this series will cover applied uses of SPL data in academic and clinical settings. The data contained within SPL, both in the specified fields in the product identification sections and the more textual fields of the content of labeling, is being used: 1) within electronic health records 2) as a support to patient safety system, and 3) a dataset for academic analysis.

OTC DRUG COMPANY - Invited The structured content of SPL allows for extraction of federal medication terminologies for downstream use. As part of “The Future of SPL: What’s Next?” webinar series, Part 3 will illuminate its uses by the drug compendia. Who are the drug

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WEBINAR compendia? Elsevier/Gold Standard, First DataBank, Micromedex, Multum and Wolters-Kluwer. These companies provide descriptive drug product and actionable clinical information.

MARY ALICE ALEXANDER Director, Global Labeling and Regulatory Operations Cubist Pharmaceuticals, Inc.

This information is used by prescribers, payers and providers of medication to ensure patient safety, accurate dispensing and efficient reimbursement. Hear from compendia, pharma/bio and FDA representatives as they highlight strengths and shortcomings of the existing SPL submission and dissemination process, and present ideas for possible changes.

JANINE MORANA Marketing Operations Analyst Cubist Pharmaceuticals, Inc.

LEARNING OBJECTIVES At the conclusion of this webinar, participants should be able to: • Explain a drug compendium (organization) and what it’s role is in patient care, drug information, and education • Describe how SPL data is used by the compendia • Discuss the future uses of SPL by the compendia • Identify potential changes to the SPL submission and dissemination process

DORIS SINCAK Project Supervisor sanofi-aventis

PAULA MARKERT Regulatory Associate, US Regulatory Affairs GlaxoSmithKline Consumer Healthcare

Sponsors spend significant time and effort in creating and maintaining product labeling in SPL documents. Besides the mandatory FDA submission, are there other uses and benefits of SPL inside your corporation? Part 4 of this series will explore this question with discussions and cases on how it is possible to leverage your SPL content for various corporate uses in: • Manufacturing for package inserts • Marketing for promotional material • Communications for company/product websites • Medical Affairs for official medical information

„ PART 4WEBINAR #12208 FEBRUARY 21, 2012 SPL Use in the Life Sciences Industry MODERATOR GARY SANER Senior Manager, Information Solutions - Life Sciences Reed Technology and Information Services Inc.

LEARNING OBJECTIVES At the conclusion of this webinar, participants should be able to: • Discuss SPL use in creating package inserts and promotional material

PRESENTERS GARY SANER Senior Manager, Information Solutions - Life Sciences Reed Technology and Information Services Inc.

DIA VISION

DIA MISSION

DIA is the global forum for knowledge exchange that fosters innovation to raise the level of health and well being worldwide.

DIA fosters innovation to improve health and well being worldwide by: • Providing invaluable forums to exchange vital information and discuss current issues related to health products, technologies, and services;

Unless otherwise disclosed, DIA acknowledges that the statements made by speakers are their own opinion and not necessarily that 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 information in any type of media, is prohibited without prior written consent from DIA.

• Delivering customized learning experiences; • Building, maintaining, and facilitating trusted relationships with and among individuals and organizations that drive and share DIA values and mandates; and to improve health and well being worldwide by indispensible forums to exchange vital information and discuss current issues;

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

• Providing Indispensible forums to exchange vital information and discuss current issues. • Offering a multidisciplinary neutral environment, respected globally for integrity and relevancy.

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WEBINAR 4-Part Webinar Series: The Future of SPL: What’s Next? PART 1WEBINAR #12204 JANUARY 24, 201211:00 AM-12:30 PM ET PART 2WEBINAR #12205 JANUARY 31, 201211:00 AM-12:30 PM ET PART 3WEBINAR #12207 FEBRUARY 14, 201211:00 AM-12:30 PM ET PART 4WEBINAR #12208 FEBRUARY 21, 201211:00 AM-12:30 PM ET

Continuing Education Drug Information Association has been approved as an Authorized Provider by the International Association for Continuing Education and Training (IACET), 8405 Greensboro Drive, Suite 800, McLean, VA 22102; +1.703.506.3275.

pate in the live webinar, and complete the on-line credit request process through My Transcript at www.diahome.org. A credit request will need to be processed for each part in the five-part webinar series. 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 two weeks after the day of each webinar in the series.

Drug Information Association is authorized by IACET to offer .2 CEUs for each live webinar in this series.

Continuing education credits are available to learners who participate in the live webinar. Continuing education credits are not available for the archived webinar.

Continuing Education Credit Allocation Part 1: The PILLBOX Initiative: Present and Future: .2 IACET CEUs

Disclosure Policy: It is Drug Information Association 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. Faculty disclosures will be included in the course materials.

Part 2: Opportunities and Challenges for Assessing Adverse Events and Warnings with SPL: .2 IACET CEUs Part 3: The Present and Future of SPLs: Uses of SPL by the Drug Compendia: .2 IACET CEUs Part 4: SPL Use in the Life Sciences Industry: .2 IACET CEUs If you would like to receive a statement of credit, you must partici-

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4-Mar 3

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WEBINAR CONTACT INFORMATION: Questions about this Webinar? Contact Colleen Braun at DIA by calling +1.215.442.6160, or email [email protected] WEBINAR: DIA accepts no liability for problems that may be encountered as a result of high traffic on the web. DIA will provide the Licensee with specific information for accessing the webinar. This information must be treated as proprietary and not given to anyone else.

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4-Part Webinar Series: The Future of SPL: What’s Next?

‰ Academia

‰ PART 1WEBINAR #12204 JANUARY 24, 201211:00 AM-12:30 PM ET ‰ PART 2WEBINAR #12205 JANUARY 31, 201211:00 AM-12:30 PM ET ‰ PART 3WEBINAR #12207 FEBRUARY 14, 201211:00 AM-12:30 PM ET ‰ PART 4WEBINAR #12208 FEBRUARY 21, 201211:00 AM-12:30 PM ET

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