FDA Information Day: who should attend. Detailed Update on the Latest Information for ICSR and IDMP. Individual Case Safety Reports

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1 FDA Information Day: Individual Case Safety Reports (ICSR) March 13-14, 2012 Event #12030 March 14-15, 2012 Event #12031 The Kirkland Center at the National Labor College Silver Spring, MD, USA PROGRAM CHAIRPERSON, EU Vada Perkins, MSc, BSN, RN Regulatory Program Management Officer PROGRAM COMMITTEE Gaby L. Danan, MD, PhD GLD Conseil Pharmacovigilance Expert, Paris, France William Gregory Senior Director, Safety and Risk Management Pfizer Inc. Caitilin Hamill, PhD Regulatory Reviewer who should attend Professionals involved in: Clinical research and development/ Clinical supplies Clinical safety and pharmacovigilance Electronic regulatory submissions- Document management Information technology Regulatory affairs 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 Detailed Update on the Latest Information for ICSR and IDMP The FDA is organizing these two Information Day events to provide the latest information about the Individual Case Safety Reports (ICSR) and the Identification of Medicinal Product (IDMP) Standards. Individual Case Safety Reports ICSR is a Health Level Seven (HL7) standard for the capture of the information needed to support the reporting of adverse events, product problems or consumer complaints associated with the use of FDA regulated products. HL7 ICSR will be used as the FDA baseline data exchange standard, and is being pilot tested to support FDA s transition to a unified electronic environment for managing all FDA-regulated product information for adverse event reports, product and consumer complaints and product problem reports. The first part of this meeting on ICSR will focus on the progress made in developing a new ICSR format by the International Conference on Harmonization (ICH) in collaboration with Standards Development Organizations. ICH recently agreed to use the International Organization for Standardization(ISO) ICSR standard to meet the reporting requirements for E2B(R3). ICH defines the way that this standard should be used by means of the ICH Implementation Guide (IG), which covers the use of the fields defined by the E2B(R3). The ICH Implementation Guide reached Step 2 in June This guide has been released for ICH Step 3 public consultation. The significant differences between the data models for E2B(R2) and E2B(R3), and a Backwards and Forwards Compatibility (BFC) document will be reviewed. Identification of Medicinal Products The second part of this meeting will focus on IDMP standards, which were developed in response to a worldwide demand for internationally harmonized specifications for exchanging medicinal product information in a robust and reliable manner. IDMP is one of a group of five standards which together provide the basis for the unique identification of medicinal products. The IDMP standards support the regulation of medicines and pharmacovigilance including ICSR. IDMP supports the activities of medicines regulatory agencies worldwide by jurisdiction. This second part will review the findings of the May 2011 ISO TC 215 meeting, where the resolution was adopted that the IDMP progresses to Final Draft International Standard (FDIS). This is a major step forward in finalizing the five IDMP standards by mid-year. The implementation planning of the ISO IDMP standards will be covered in this part of the meeting. These two 1.5-day Information Day meetings are being held back to back, allowing you to choose one or both to best suit your educational needs. Co-sponsored by

2 2 continuing education credits FDA Information Day: Individual Case Safety Reports (ICSR) Learning objectives: At the conclusion of this meeting, participants should be able to: Discuss the ongoing international standardization work on ICSR Recognize the main new features of the ICSR standards Prepare for the implementation of the new ICSR standards for adaptation in pharmacovigilance systems Learning objectives: At the conclusion of this meeting, participants should be able to: Discuss the ongoing international standardization work on IDMP Recognize the main new features of the IDMP standards Prepare for the implementation of the new IDMP standards for adaptation in pharmacovigilance systems Corexcel is accredited as a provider of continuing nursing education by the American Nurses Credentialing Center s Commission on Accreditation. Corexcel designates these activities for a maximum of contact hours. 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 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 up to 1.8 CEUs for these programs. Participants must attend each program in its entirety in order to be able to receive an IACET statement of credit. No partial credit will be awarded.. 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 at 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 March 29, 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 program materials. CONTINUING EDUCATION CREDIT ALLOCATION FDA Information Day: Individual Case Safety Reports (ICSR): 8.75 nursing contact hours;.9 IACET CEUs : 9 nursing contact hours;.9 IACET CEUs These programs are part of DIA s Certificate Program and are awarded the following: Clinical Safety and Pharmacovigilance Certificate Program: 4 Elective Units each For more information go to 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. To view DIA s Grievance Policy, please visit the CE page on DIA s website at FDA Information Day: The Latest on the Individual Case Safety Reports (ICSR) March 13-14, 2012 Event #12030 DAY 1 ICSR Tuesday, March 13, :45-8:45 am REGISTRATION AND CONTINENTAL BREAKFAST 8:45-9:00 am ICSR WELCOME AND OPENING REMARKS Program Chairpersons 9:00-9:30 am SESSION 1 LATEST STATUS OF THE PROCESS AND THE INTERNATIONAL STANDARDS DEVELOPMENT This session will provide participants with an update of the progress made in developing a new ICSR format by the International Conference on Harmonisation (ICH) in collaboration with Standards Development Organizations. The objective is to improve the current ICSR and to achieve a wider interoperability of the information exchange across the regulatory and healthcare communities. Ta-Jen Chen Project Manager Office of Information Management, FDA 9:30-11:00 am SESSION 2 DIFFERENCES BETWEEN THE NEW INTERNATIONAL ORGANIZATION FOR STANDARDIZATIONS (ISO) ICSR E2B (R3) STANDARD AND THE CURRENT ICH ICSR E2B (R2) GUIDELINE This session aims to describe the key differences between the new International Organization for Standardizations (ISO) ICSR standard and the ICH E2B(R2) guideline/m2 message specifications that currently serve as the basis for the electronic reporting of adverse reactions. The impact on the pharmacovigilance business processes will be also highlighted and requirements for future system changes. Gaby L. Danan, MD, PhD GLD Conseil Pharmacovigilance Expert, France 11:00-11:30 am REFRESHMENT BREAK 11:30-12:15 pm SESSION 3 ICSR ACKNOWLEDGEMENT MESSAGE BASED ON HL7 AND ISO STANDARDS The key principles of the ICSR acknowledgement messaging based on the HL7 and ISO standards will be explained in this session. Ta-Jen Chen Project Manager Office of Information Management, FDA

3 3 12:15-1:15 pm LUNCHEON 1:15-2:15 pm SESSION 4 VACCINE REPORTING REQUIREMENTS This session will focus on US regional requirements for vaccine AE reporting to FDA. The session will describe how to extend relevant sections of the ICH implementation guide and XML schema instance example to support additional data elements and vocabulary based upon the information captured using the FDA/ CDC VAERS-1 form. 2:15-3:00 pm SESSION 5 USE OF MedDRA FOR ADVERSE EVENT REPORTING The collection of information on suspected adverse reactions will be addressed to include the use of medicinal products within the terms of the marketing authorization as well as from use outside the terms of the marketing authorization, including overdose, misuse, abuse and medication errors, and suspected adverse reactions associated with occupational exposure. The appropriate use of MedDRA (Medical Dictionary for Regulatory Activities) to facilitate the ICSR coding in this special situations will be also presented. Daniela J. Vanco, MD Medical Officer 3:00-4:00 pm SESSION 6 ICH E2B(R2) AND (R3): HOW TO APPROACH THE BACKWARDS AND FORWARDS CONVERSION This session will focus on the approach as to how to ensure consistency in migrating from the current to the new ICSR standard. Backwards and forwards conversion conventions will be part of the ICH Implementation Guide, whereby the key principles and challenges will be highlighted during this session. 4:00 pm ICSR MEETING DAY 1 ENDS DAY 2 ICSR Wednesday March 14 8:30-9:00 am CONTINENTAL BREAKFAST 9:00-10:00 am SESSION 7 FDA PERSPECTIVE: CURRENT & FUTURE IMPLEMENT OF ICSR The aim of this session is to discuss the preparation of an FDA Implementation Strategy for the ICSR standard and the future ISO Identification of Medicinal Products (IDMP) standard, both being strongly interlinked for the purpose of pharmacovigilance. The timelines for the finalization of the standards and the achievement of ICH step 4 of the Implementation Guide will be presented in the context of the overall planning. Deborah Yaplee Senior Program Manager Lonnie D. Smith Policy Analyst, Data Standards Council and Office of Critical Path Programs, Office of the Commissioner FDA 10:00-11:00 am SESSION 8 ICSR IMPLEMENTATION IN THE EMA The aim of this session is to discuss the preparation of an EU Implementation Strategy for the ICSR standard and the future ISO IDMP standard, both being strongly interlinked for the purpose of pharmacovigilance. The timelines for the finalization of the standards and the achievement of ICH step 4 of the Implementation Guide will be presented in the context of the overall planning. 11:00-12:00 am SESSION 9 ICSR AND RELATIONSHIP TO IDENTIFICATION OF MEDICINAL PRODUCTS (IDMP) This session will provide an overview of the new pharmacovigilance legislation and its interface with the IDMP and ICSR ISO standards. It will further provide an insight on how the standards will be applied for adverse reaction reporting and signal detection in pharmacovigilance. 12:00 pm ICSR MEETING ADJOURNS 12:00-1:00 pm LUNCHEON FOR THOSE REGISTERED FOR BOTH ICSR & IDMP FDA Information Day: The Latest on the Identification of Medicinal Products (IDMP) March 14-15, 2012 Event #12031 DAY 1 IDMP Wednesday March 14, :00-1:00 pm IDMP REGISTRATION 1:00-1:15 pm IDMP WELCOME AND OPENING REMARKS Program Chairpersons 1:15-2:00 pm SESSION 1 OVERVIEW OF IDMP IN THE CONTEXT OF INTERNATIONAL ORGANIZATION FOR STANDARDIZATION (ISO) This session will provide participants with an introduction to the five IDMP standards, which together with the Individual Case Safety Report (ICSR), are the first topics to go through this new standardization process, whereby the International Organization for Standardization (ISO), Health Level 7 (HL7), the European Committee for Standardization (CEN), the Clinical Data Interchange Standards Consortium (CDISC) and the International Health Terminology Standards Development Organization (IHTSDO) agreed to form a Joint Initiative. Participants will be also briefed about the ISO processes and steps in developing standards in the context of the Joint Initiative. Michael L. Glickman President Computer Network Architects, Inc.

4 4 2:00-3:00 pm SESSION 2 ISO FINAL DRAFT INTERNATIONAL STANDARD (FDIS) HEALTH INFORMATICS Taking into account that there are currently different approaches applied for expressing units of measurement, it was necessary to establish a single standardized vocabulary that can be used as an international reference for unit concepts, concept definitions where applicable and concept identifiers. This session will give participants the opportunity to familiarize with the latest updates on this FDIS. The aim is to ensure that terms and identifiers currently used to represent units of measurement in the drug regulatory, pharmacovigilance and healthcare environments are mapped in a standardized and traceable way to the underlying metrological concepts. This will help ease implementation of the standard without impacting on the unit terms currently in use. Aniello Santoro EMA, UK Via telephone Christof Gessner German Institute For Medical Documentation and Information, Germany Via telephone 3:00-3:30 pm REFRESHMENT BREAK 3:30-4:30 pm SESSION 3 ISO FDIS HEALTH INFORMATICS This session will address the identification of pharmaceutical dose form, unit of presentation, routes of administration and packaging in the context of the IDMP FDIS. The essential elements for the specification, translation and versioning of the specified controlled terms will be described including recommendations concerning the mapping of terms that are already used by stakeholders to the concepts arising from the implementation of this standard. Christopher Jarvis EDQM Council of Europe 4:30 pm IDMP MEETING DAY 1 ENDS DAY 2 IDMP Thursday March 15 8:00-8:30 am CONTINENTAL BREAKFAST 8:30-9:45 am SESSION 4 ISO FDIS HEALTH INFORMATICS This session will provide a detailed overview of the FDIS that has been developed to define the concepts required for the unique identification of substances at an international level. Furthermore, the concept of a specified substance has been elaborated allowing to capture more detailed characteristics of substances. This can relate to e.g. intermediate products that contain multiple substances or specified substances of diverse origin and taking into account features such as physical forms, constituents, components, marker substances, additives, impurities, manufacturing information, critical production processes, etc. Various examples for different substance classes will be also presented to illustrate the specific concepts to be applied according to the FDIS. The use of HL7 messages for the information exchange on substances will be also discussed. Lawrence Callahan Chemist OCS, FDA 10:15-11:15 am SESSION 4 CONTINUED ISO FDIS HEALTH INFORMATICS Frank L Switzer, PhD Chemist, Substance Registration System FDA 11:15 am-12:00 pm SESSION 5 ISO FDIS HEALTH INFORMATICS This session will focus on the presentation of the data elements, structures, and their relationships to uniquely identify and exchange regulated pharmaceutical product information. This refers to both packaged and administered pharmaceutical products. The standard will be applicable to regulatory and pharmacovigilance activities worldwide. The association with the other IDMP and HL7 messaging standards will be also described. 12:00-1:00 pm LUNCHEON 1:00-2:00 pm SESSION 6 ISO FDIS HEALTH INFORMATICS This session will be dedicated to provide participants with an overview of the main changes introduced in the FDIS. ISO FDIS has been developed to characterize and uniquely identify regulated medicinal products for human use during their entire life cycle from development, to approval and marketing. More specifically, the standard establishes definitions and concepts and describes data elements and their structural relationships, which are required for the detailed description and unique identification of medicinal products. Furthermore, to support the successful information exchange in relation to the unique identification and characterization of medicinal products, the use of HL7 messaging will be also addressed. 2:00-2:30 pm REFRESHMENT BREAK 2:30-3:15 pm SESSION 6 CONTINUED ISO FDIS HEALTH INFORMATICS 3:15-4:30 pm SESSION 7 IMPLEMENTATION OF IDMP FROM AN EMA, FDA PERSPECTIVE The implementation planning of the ISO IDMP standards will conclude this event. The session will also cover Article 57 and SPL. 4:30 pm IDMP MEETING ADJOURNED 9:45-10:15 am REFRESHMENT BREAK

5 Register for both meetings by February 29, 2012 and save $200! 5 REGISTRATION FORM Register online or fax this page to FDA Information Days: Individual Case Safety Reports (ICSR) Event #12030 March 13-14, 2012 Event #12031 March 14-15, 2012 The Kirkland Center at the National Labor College Select a meeting for registration. ICSR (12030) IDMP (12031) Rates are: Industry: $650 Nonprofit: $450 Government: $400 Register for both meetings by February 29, 2012 and save $200 3-day: Industry: $1100 Charitable Nonprofit/Academia: $700 Government: $600 Payment options: Register online at or check payment method. Credit Card number may be faxed to: You may prefer to pay by check or bank transfer since non-u.s. credit card payment will be subject to the currency conversion rate at the time of the charge. Visa MC AMEX Exp Date Card # Name (printed) Signature Check drawn on a US bank payable to and mailed along with this form to: Drug Information Association Inc, P.O. Box , Philadelphia, PA , USA. Please include a copy of this registration form to facilitate identification of attendee. Bank Transfer When DIA completes your registration, an will be sent to the address on the registration form with instructions on how to complete the Bank Transfer. Payment should be made in US dollars. Your name and com pany, as well as the Event I.D. # must be included on the transfer document to ensure payment to your account. TRAVEL AND HOTEL The most convenient airport is Washington Dulles International or Reagan National Airport and attendees should make airline reservations as early as possible to ensure availability. The Kirkland Center at the National Labor College is holding a block of rooms at the reduced rate below until February 26, 2012, for the DIA event attendees. Room availability at this rate is guaranteed only until this date or until the block is filled. Single $139 Double $149 Please contact the The Kirkland Center at the National Labor College by telephone at or and mention the DIA event. The hotel is located at New Hampshire Ave, Silver Spring, MD 20903, USA. cancellation Policy: On or before MARch 6, 2012 Administrative fee that will be withheld from refund amount: Industry = $200 Government or Academia or Nonprofit (Member or Nonmember) = $100 Tutorial (if applicable) = $50 Cancellations must be in writing and be received by the cancellation date above. Registrants who do not cancel by that date and do not attend will be respons ible for the full registration fee paid. Registrants are responsible for cancelling their own hotel and airline reservations. You may transfer your registration to a colleague at any time but membership is not transferable. Please notify DIA of any such substitutions as soon as possible. Substitute registrants will be responsible for nonmember fee, if applic able. 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. Participants with Disabilities: DIA event facilities and overnight accommodations are accessible to persons with disabilities. Services will be made available to sensory-impaired persons attending the event if requested at least 15 days prior to event. Contact the DIA office to indicate your needs. event information For registration questions, please contact Vicki Adkinson by phone at or by at Vicki.Adkinson@diahome.org. For agenda details, please contact Program Manager Ellen Diegel by phone at or by at Ellen.Diegel@diahome.org. Please check the applicable category: q Academia q Government q Industry q CSO q student (Call for registration information) Last Name First Name M.I. Degrees q Dr. q Mr. q Ms. Job Title Company Address (As required for postal delivery to your location) Mail Stop City State Zip/Postal Country Required for confirmation Phone Number Fax Number Required for confirmation