What s New for MedDRA Version 14.1

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1 September 2011 Published by MedDRA MSSO for our Users Quick Links What s New for MedDRA Version 14.1 Request to Add a New SMQ Removal of Codes of Earlier Terminologies from MedDRA Improvements to Italian MedDRA Pregnancy Exposure Terms Pharmacogenetic/ Pharmacogenomic Terms WebCR Upgrade Available Friends of MedDRA MedDRA MSSO Maintains ISO 9001:2008 Certification 2011 User Group Meetings MedDRA Training What s New for MedDRA Version 14.1 By Brian J. O Hare Terminology Maintenance Manager eddra Version 14.1 was made available to subscribers on 1 September 2011 from the MSSO Web site There were a total of 1337 change requests processed for this version including SMQ change requests; 1041 change requests were approved and implemented, and 233 change requests were rejected. There are, in addition, 63 change requests suspended for further consideration and resolution beyond this version. MedDRA v14.1 is a simple change version which means changes are made only at the PT and LLT levels. Please see the What s New MedDRA Version 14.1 document for specific details. In addition to terminology changes, there were 106 translation correction requests considered and 103 changes implemented to replace misspelled or mistranslated terms in the non-english versions of MedDRA. Below is a summary of the number of changes made and the languages affected. 7 Chinese 90 French 4 German 2 Spanish Number of Terms: MedDRA Version 14.1 System Organ Classes (SOC) 26 High Level Group Terms (HLGT) 335 High Level Terms (HLT) 1710 Preferred Terms (PT) Lowest Level Terms (LLT) Standardised MedDRA Queries (SMQ) 86 The large number of changes to French MedDRA is due to efforts by the MSSO and the Canadian regulatory authority, Health Canada, to identify and correct issues with the French translation. Continued on page 10 1

2 By Patricia Mozzicato, MD Chief Medical Officer, MedDRA MSSO Request to Add a New SMQ ome MedDRA users may be unaware that they have the option to submit a change request (CR) for a new Standardised Med- DRA Query (SMQ). With the recently updated WebCR tool ( webcr/), subscribers can input their request for a new SMQ directly into the tool just like an ordinary Med- DRA CR. A request to Add a new SMQ is a simple CR, meaning these requests are reviewed and considered for every version of MedDRA. When submitting a request for a new SMQ, you are encouraged to submit a list of proposed PTs to populate the query. No matter how many PTs are on the list of proposed terms, the request to add a new SMQ is considered a single CR; so even if your list contains many terms, the included PTs do not count against your monthly allotment of 100 CRs per subscriber. Once the MSSO receives a request to add a new SMQ, the information is forwarded to the ICH Advisory Panel whose members are also on the CIOMS SMQ Working Group. The ICH Advisory Panel is responsible for deciding which requests should be developed into SMQs. If the request is rejected, the Panel provides a rationale which is then posted and sent back to the subscriber like other rejected requests. When submitting a request for a new SMQ, you will be asked to answer the following five questions to help the ICH Advisory Panel evaluate the request: 1. What is the scientific/ pharmacovigilance question that led to the request for this SMQ? 2. Is the current MedDRA hierarchy (e.g., HLTs, PTs) or any existing SMQ suitable to address the question? If not, what are the deficiencies in the hierarchy or existing SMQs that should be addressed? 3. Would your organization be able to address this question without this new SMQ, and if so, how? (That is, what would be the strategy and terms used?) 4. Which SMQ structure (i.e., broad/narrow, hierarchical, algorithm) do you think would best address the question? 5. How often would your organization need this SMQ (e.g., only once to address a very specific emerging issue or regularly/routinely)? Besides using WebCR, subscribers may also submit a request to add a new SMQ on the SMQ Change Request form, which is available on the Change Request page of the MSSO Web site. This SMQ Change Request spreadsheet also contains the five questions that the ICH Advisory Panel needs answered to evaluate the request. Because SMQs take time to construct and test, a request to add a new SMQ is typically suspended until the new SMQ is put into production or until the ICH Advisory Panel provides a rejection rationale. Therefore, the usual 7 to 10 working day timeline for responding to a MedDRA CR does not apply to new SMQ requests. If the ICH Advisory Panel decides to accept the topic for a new SMQ, the MSSO initiates the process of developing and testing it within the CIOMS SMQ Working Group. The MSSO encourages you to consider adding a new SMQ as part of your routine for helping us maintain MedDRA as a rigorous terminology responsive to user needs. WE WANT YOUR FEEDBACK! PLEASE CONTACT US TOLL FREE INTERNATIONAL MSSO HELP DESK WEB SITE: TWITTER: 2

3 By Patrick Revelle MSSO Director Removal of Codes of Earlier Terminologies from MedDRA ince the initial release of MedDRA (v2.1) in March 1999, the terminology has included numeric or symbol codes from earlier terminologies. The codes are links from other terminologies to similar or identical terms in MedDRA. This includes codes from COSTART, WHO-ART, ICD9, ICD9-CM, HARTS, and JART. The ICH M1 Expert Working Group who created the original version of MedDRA included these codes with the text of the terms believing that the codes would be useful in the transition to MedDRA. Because most organizations have long since migrated their data to MedDRA, and to avoid potential confusion because these codes have not been maintained or updated since the original release of MedDRA, the MSSO intends to remove these codes from all of MedDRA starting with the release of MedDRA v15.0 (March 2012). The following points should be noted: 1. No terms will be removed from MedDRA as a part of this effort; only the codes and symbols associated with earlier terminologies will be removed. 2. The MedDRA code assigned to each term will not be changed in this process. 3. The structure of the distributed ASCII files will not change. The entries in the distribution files for these earlier codes will be empty (i.e., null fields). If you or your organization have any concerns about the removal of the codes, please contact the MSSO Help Desk by 1 November In the event that no major concerns are raised, the MSSO will proceed to remove these codes. 3

4 Improvements to Italian MedDRA - an Interview with Dr. Ugo Moretti By Dr. Tomás Moraleda International Medical Officer o keep up the quality of MedDRA language translations, the MSSO has begun to engage with regulatory authorities to determine what quality issues they have noted and how they would like to address them. As part of this effort, the MSSO visited the Italian regulatory authority Agenzia Italiana del Farmaco, (AIFA) in October A substantial number of corrections to the Italian translation have been made since then, involving around 700 change requests. Dr. Ugo Moretti responsible for the Regional Pharmacovigilance Centre of the Veneto Region and also Aggregate Professor of Pharmacology in the Faculty of Medicine of the University of Verona, Italy was a key person in the identification and correction of issues with Italian MedDRA. We thought it would be interesting to ask Dr. Moretti some questions concerning AIFA s experience in collaboration with the MSSO ) How much or how often do staff at AIFA use the Italian translation of MedDRA? The Italian version of MedDRA is extensively used within the Italian spontaneous reporting system. The system in Italy is highly decentralized. Reporters send the forms to a Local Health Unit where a pharmacist in charge of the pharmacovigilance enters the form in the Italian database, coding the information with Italian MedDRA. Since about 400 Units are present in Italy, the system gives the opportunity to have close relationships with the reporters, improving reporting and feedback information. On the other hand, the training in coding of such a high number of persons is a challenging task. More than 20,000 reports were inserted last year in the database. Regional Centers have been recently added to the system to support and validate the coding activity. In the National Agency (AIFA) the Italian version of MedDRA is used also in the Clinical Experimentation Office whereas the English version of the terminology is used in the Agency in all the procedures related to the European Medicines Agency (EMA). 2) Describe the main issues in Italian MedDRA that you brought to the MSSO s attention. How were these issues addressed? The need to review some aspects of the Italian translation of MedDRA was suggested by analyzing the use of the terminology in spontaneous reporting. Some of the identified coding errors were related to the translation. An analysis of the problems related to the Italian translation of MedDRA was performed, and the issues were brought to the MSSO s attention. The first issue identified was the lack of many acronyms generally used in medicine (e.g. CPK, SGOT, SGPT, etc.) leading to coding challenges by the pharmacists in the Local Units. The analysis also identified a problem of redundancy i.e., different English LLTs translated with the same Italian term leading to a reduced availability of Italian terms. There were other issues, e.g., terms with the string emia and uria had been erroneously assigned to SOC Investigations (e.g., Glicemia aumentata instead of Glucosio ematico aumentato). A proposal to make corrections to the Italian translation was discussed with the MSSO, and a solution was found for most of the problems. 3) What were the positive aspects of the AIFA and MSSO collaboration to address the Italian Med- DRA issues? How could the collaboration be improved? MSSO since the beginning was interested in the review and ready to collaborate to improve the Italian translation. They discussed the problems we brought to their attention, and they realized that some of the same problems could also be present in the other translations of MedDRA. At the same time, they explained to us the MedDRA term translation conventions. For example, British/American spelling variation of the same term (e.g. Oedema/Edema) or reverse word order pairs in English (e.g. Brain edema/edema brain) cannot be translated with different Italian terms. For each issue, we proposed different solutions that were discussed with the MSSO to arrive at an agreeable solution. Some of the issues have now been finalized, and others are still in progress. In the future, we hope we will be able to improve the collaboration with the MSSO, with a goal of a complete analysis of the Italian translation. From the AIFA point of view, an important point. Continued on page 10 4

5 By Brian J. O Hare Terminology Maintenance Manager Pregnancy Exposure Terms ased on suggestions from the ICH Points To Consider Working Group, new sets of pregnancy exposure terms have been added (e.g., PT Exposure during breast feeding, PT Foetal exposure during delivery) and existing terms reorganized to make them more self explanatory and easier to use for pharmacovigilance purposes. Regroupings involving hierarchical changes will be implemented in v15.0 for March Both the new and existing terms were organized to refer to circumstances involving transmission of various agents through intimate contact (e.g., mother to fetus or newborn, between partners, etc). The two main circumstances considered are exposures related to pregnancy and lactation, and terms representing relevant forms of potential transmission of various agents through intimate contact (e.g., PT Exposure via partner). Existing terms where an actual harm is proved were not part of this set, even if they convey the concept of a pregnancy or intimate related previous exposure (e.g., PT Maternal drugs affecting foetus and PT Anaesthetic complication foetal). Additionally, existing exposure terms related to an agent or form of contamination which does not involve intimate contact and is only applicable to one individual (e.g., PT Exposure to toxic agent) were not included in this reorganization. Terms related to exposures to communicable diseases or environmental occupational and non-occupational exposures were not included either. Below is a summary of changes for v new terms (14 PTs, 15 LLTs) 19 moved terms (10 PTs, 9 LLTs) 6 demoted PTs The MSSO plans to make additional changes to pregnancy exposure terms at the HLT and HLGT level for MedDRA v15.0. These changes are summarized as follows: Add HLGT Exposures, chemical injuries and poisoning to SOC Injury, poisoning and procedural complications. The proposed HLGT will replace existing HLGT Chemical injury and poisoning in SOC Injury, poisoning and procedural complications. Add HLT Exposures associated with pregnancy, delivery and lactation to proposed HLGT Exposures, chemical injuries and poisoning. The proposed HLT will replace HLT Pregnancy related accidental exposures and injuries. Add an additional link for new HLT to HLGT Pregnancy, labour, delivery and postpartum conditions in SOC Pregnancy, puerperium and perinatal conditions. The PTs in HLT Exposures associated with pregnancy and lactation would be primary to SOC Injury, poisoning and procedural complications with a secondary link to SOC Pregnancy, puerperium and perinatal conditions. Add proposed HLT Exposures NEC (excl medication errors due to accidental exposures) to proposed HLGT Exposures, chemical injuries and poisoning. MedDRA MSSO MSSO Help Desk Toll Free International

6 Pharmacogenetic/Pharmacogenomic Term Initiative By Savian Nicholas, MD International Medical Officer harmacogenetics and pharmacogenomics are rapidly advancing areas of research that may lead to development of therapies tailored to an individual patient's genetic profile. As a proactive maintenance initiative based on a MedDRA user request, the MSSO has added to MedDRA Version 14.1 an initial group of pharmacogenetic/pharmacogenomic terms that have potential relevance for MedDRA users. Recognizing that pharmacogenetics and pharmacogenomics are sometimes used synonymously, and have a variety of definitions, the MSSO considers the term pharmacogenetics to be inclusive of both concepts. Because there are numerous theoretical and investigational pharmacogenetic concepts described in the scientific literature, the initial group of MedDRA pharmacogenetic/pharmacogenomic terms is focused on having at least one of the following criteria: A genetic concept that has an impact on drug therapy A genetic assessment or test that helps to identify the most appropriate or effective therapy for a specific patient, or helps to objectively select patients that have a high probability of benefitting from a specific therapy. Four HLTs have been selected for placement of the new terms. Two are existing HLTs and two are Complex Changes forthcoming in v15.0: HLT Cell marker procedures in SOC Investigations (e.g., PT Androgen receptor assay) HLT Cell metabolism disorders NEC in SOC Metabolism and nutrition disorders (e.g., PT NAT2 polymorphism) New HLT for v15.0: Gene analyses in SOC Investigations (e.g., PT Gene mutation identification test) New HLT for v15.0: Acquired mutations and other alterations, in SOC General disorders and administration site conditions (e.g., PT K-ras mutation) Two additional Complex Changes (for MedDRA v15.0) relevant to pharmacogenetic terms are as follows: The merging of existing HLT Acquired mutations NEC to new HLT Acquired gene mutations and other alterations, to group all non-germ cell genetic alterations in one HLT The moving of HLT Cell marker procedures from HLGT Immunology and allergy investigations to HLGT Cytogenetic investigations to group terms such as PT Androgen receptor assay, and PT Oestrogen receptor assay The MSSO encourages MedDRA users to become familiar with the initial pharmacogenetic terms, as we anticipate the addition of future terms of this nature in response to the needs of MedDRA users. WebCR Upgrade Available By Brian J. O Hare Terminology Maintenance Manager he MSSO deployed an upgraded version of WebCR ( the on-line application for MedDRA users to submit change requests, in July The enhanced version now supports Standardised MedDRA Queries (SMQs) and Translation Correction change requests. In addition, the user interface has been improved, and issues with the previous WebCR version have been corrected. For information about how to use WebCR, please view the WebCR Quick Reference guide located on the change request section of the MSSO Web site. More detailed information can be found in the Change Request Information document also located on the change request section of the MSSO Web site. If you have any questions, please contact us at the MSSO Help Desk. 6

7 Friend of MedDRA Awards to Two Individuals By Brian O Hare Terminology Maintenance Manager he MSSO is pleased to recognize two individuals who are recipients of this year s Friend of MedDRA (FOM) awards. The award is presented to MedDRA users who have demonstrated a sustained level of support to MedDRA through active participation in Med- DRA activities, helping the MSSO resolve difficult issues, and being a resource for MedDRA experience to fellow users. At the MedDRA User Group meeting in March 2011, in Geneva, the FOM was presented to Dr. Norbert Paeschke of BfArM (the German regulatory authority). In June 2011, at the MedDRA User Group meeting in Chicago, USA, the FOM was awarded to Dr. Sonja Brajovic of the US FDA. The MSSO congratulates the 2011 FOM awardees and looks forward to recognizing future deserving supporters. 7

8 MedDRA Maintenance and Support Services Organization (MSSO) Maintains ISO 9001:2008 Certification By Mike Burke Manager, Quality Assurance Effective 26 August 2011, the MedDRA MSSO successfully maintained its ISO 9001:2008 certification from BSi, a quality management systems registrar. The ISO 9001:2008 standard, released in November 2008, is an internationally recognized quality management system standard developed by the International Organization for Standardization (ISO). To be certified to the standard, enterprises must implement a Quality Management System (QMS) encompassing the activities of the enterprise for controlled product planning, training on roles and responsibilities in the QMS, controlled development of products, controlled purchasing of materials and services, and controlled delivery of the products and services. Certification to ISO 9001:2008 reinforces to customers, through an independent third-party, that the MSSO operates a QMS for the maintenance of MedDRA in accordance with the standard. Pat Revelle, MSSO Director, notes: "We are proud to maintain a certification to the ISO 9001:2008 standard. It demonstrates our continuing commitment to MedDRA subscribers that the MSSO is heavily engaged in process improvement, world-class performance, and is continuously monitoring our terminology maintenance operations to ensure that we deliver on the commitments and performance requirements we make to our subscribers and vendors." The MSSO achieved its first certification to the ISO 9001:2000 standard on 14 November 2003, and then its certification to the ISO 9001:2008 on 18 August Certification is maintained through inspections for compliance to the parts of the ISO standard that apply to MSSO processes. In this recent inspection, the MSSO demonstrated full compliance. MedDRA is a registered trademark of the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA). BSi is a trademark of BSI Management Systems America, Inc. 8

9 By Brian J. O Hare Terminology Maintenance Manager 2011 User Group Meetings he MSSO User Group meetings provide an opportunity for MedDRA users to meet face-to-face and to discuss MedDRA related topics, to ask questions directly to the MSSO, and to share experiences with other users. In 2011, the MSSO conducted User Group meetings in Geneva (March), in Shanghai (May), and in Chicago (June). At the Geneva User Group meeting, Emil Cochino of the European Medicines Agency (EMA) provided information on the background, development, improvements, and maintenance mechanism of the Important Medical Events list. The goal of the list is to facilitate the classification of suspected adverse reactions, aggregated data analysis and case assessment in the EU. James Buchanan of BioSoteria, Inc. delivered a presentation on signal detection using MedDRA during the Chicago User Group meeting. At both the Geneva and Chicago meetings, the MSSO discussed the proactive MedDRA maintenance process which is a way MedDRA users can suggest general improvement to MedDRA outside of the change request process. In addition, the MSSO discussed proposed revisions to the Neoplasm SOC in the March meeting and the Blue Ribbon Panel 7 recommendations on those proposals in the June meeting. On 10 May 2011, the MSSO conducted an interactive coding discussion during the User Group meeting in Shanghai China. A panel of expert coders with experience using Chinese MedDRA fielded coding questions from participants. The discussion provided a great opportunity to ask tough coding questions of the panel. Please visit us at the Drug Information Association Annual Meetings 24th EuroDIA Annual Meeting Copenhagen, Denmark March th US DIA Annual Meeting Philadelphia, PA USA June 2012 and the MedDRA User Group Meetings MedDRA User Group Meeting Copenhagen, Denmark 29 March 2012 Philadelphia, PA USA 28 June 2012 For detailed information on 2011 MSSO User Group meetings, please visit the MSSO Web site. The MSSO hopes to see you at the next User Group meetings. The MSSO encourages attendance by both new subscribers and veteran MedDRA users! Please visit the MSSO Web site for information on past and future meetings, or contact the MSSO Help Desk. Interactive coding discussion by a panel of expert coders May 2011, Shanghai User Group Meeting 9

10 What s New for Version 14.1 Continued from page 1 SMQ Changes Two new level 1 SMQs were released into production in MedDRA v14.1 SMQ Hypotonichyporesponsive episode and SMQ Fertility disorders. There are now 86 level 1 SMQs in production as of this version. SMQ Events specifically reported as alcohol-related, a sub-search SMQ under SMQ Hepatic disorders, was renamed to SMQ Hepatic disorders specifically reported as alcohol-related. The name of SMQ Events specifically reported as alcohol-related, when seen in isolation, could lead one to believe that the SMQ includes all alcohol related events, instead of events only related to alcohol-associated liver disease. The new name provides a more intuitive description for this SMQ. Please see the Introductory Guide for Standardised MedDRA Queries (SMQs) v14.1 for details on these changes. In addition to new and renamed SMQs, there has been one major change made to SMQs for this version - the removal of inactive SMQ Adverse pregnancy outcome/reproductive toxicity (incl neonatal disorders). In MedDRA v14.0, SMQ Adverse pregnancy outcome/ reproductive toxicity (incl neonatal disorders) was made inactive and replaced with SMQ Pregnancy and neonatal topics which is designed to reflect the regulatory goals for monitoring of product safety related to pregnancy outcomes. The MSSO removed SMQ Adverse pregnancy outcome/reproductive toxicity (incl neonatal disorders) from the MedDRA distribution files prior to the release of v14.1 and made it available as a separate download on the MSSO Web site in the SMQ archive section. Please note that the archived version of SMQ Adverse pregnancy outcome/reproductive toxicity (incl neonatal disorders) will be as it was in MedDRA v13.1, the most recent version of this SMQ in active status. Interview with Dr. Ugo Moretti Continued from page 4 is to involve Pharmacovigilance Regional Centres. They are often located within University Hospitals and have the potential to assign human resources for this work. 4) Do you have any recommendations to other users of MedDRA translations e.g., other regulatory authorities? During the conversations we had with the MSSO staff, I asked if they had data on the use of the different translations of MedDRA, including both number of persons and context of use. Unfortunately no exact data are available. In my view, drug companies that have multinational activities and centralized coding procedures use English versions of MedDRA. MedDRA translations are probably used by regulatory authorities, both in pharmacovigilance and other drug/medical information related issues. I think that the starting point for good quality of coding is to have a good translation, and the time spent to improve the quality of the translation will give optimal results. Even if the initial translation is made by an expert team of physicians, it has to be tested in daily practice to identify problematic issues. MSSO collaboration is essential to coordinate this work. Since we have seen that many issues are common to the different translations, I think that a working group collecting different experiences with the translations could be very useful The MSSO hopes this brief interview may encourage other users of MedDRA translations to send change requests whenever they notice errors and other quality issues. We also want to remind users that the recently updated Web based change request application WebCR has a module devoted to translation changes to facilitate submission of these requests. The MSSO thanks Dr. Moretti and all the staff at AIFA for helping us improve the Italian translation of Med- DRA. 10

11 MedDRA Training Schedule 2011 Listed below are the currently scheduled MSSO classes and webinars. This training schedule is subject to change. Please refer to the MSSO Web site. OPEN REGISTRATION WEBINARS Webinars Introduction to MedDRA 9 November 2011 MedDRA Versioning 26 October 2011 What s New with MedDRA August September 2011 Medication Error and Product Quality Issue Concepts in MedDRA 2012 Schedule to be determined Certified MedDRA Coder: Examination Preparation 14 September December 2011 FREE TRAINING SESSIONS for SUBSCRIBERS: Coding with MedDRA MedDRA: Safety Data Analysis and SMQs Webinars Kenilworth, NJ, USA 7 September 2011 Kenilworth, NJ, USA 8 September 2011 MedDRA Coding Basics 2012 Schedule to be determined Bonn, Germany 20 October 2011 Introduction to MedDRA Data Analysis and SMQs for Physicians 19 October 2011 MedDRA Training From the Web Videocasts The current topics are Primary System Organ Class (SOC) Allocation in MedDRA and MedDRA Desktop Browser: Research Bin and Export Functions. Data Quality, Coding and MedDRA Training presentation This presentation provides tools to help improve the quality of initial data. It includes a discussion of the importance of collecting quality data related to MedDRA coding and analysis. Place holder slides allow you to customize the presentation to company-specific data collection and reporting conventions, a feature that can be a very useful adjunct for investigator training. Registration for all sessions can be accomplished through the MedDRA MSSO Web site Training Page 11

12 MedDRA Course Descriptions Coding with MedDRA This one day course is designed to provide an understanding of the scope, structure, and characteristics of MedDRA and the application of the terminology in coding clinical data. It is designed for individuals involved with coding, those affected by coding guidelines and associated standard operating procedures, and those involved with synonym lists. Participants will be given an overview of the MedDRA Term Selection: Points to Consider document, and will perform hands-on coding exercises to demonstrate the principles described in the document. Who Should Attend? Clinical monitors, data managers, regulatory affairs professionals, and communications staff. MedDRA: Safety Data Analysis and SMQs This one day course is designed to provide an overview of the features of MedDRA that relate to the Webinar Topics Introduction to MedDRA (2 hours) This webinar is designed to provide a basic understanding of the scope, structure, characteristics, and maintenance of MedDRA, and the relevant regulations concerning its use. In addition, it provides an overview of coding with MedDRA and applications of MedDRA in data retrieval and analysis, including use of Standardised MedDRA Queries (SMQs) in safety signal detection and case identification. Introduction to MedDRA Data Analysis & SMQs for Physicians (2 hours) This webinar presentation provides a brief overview of MedDRA and an introduction to the applications of MedDRA for data presentation, retrieval, and analysis (including use of SMQs) from a medical perspective. MedDRA Coding Basics (1.5 hours) Coding Basics provides a brief overview of MedDRA; introduces the MedDRA Term Selection: Points to Consider document; uses coding examples to illustrate general principles of coding; and provides trainees with a set of coding pearls based on the broad coding experience of MSSO's medical personnel. Certified MedDRA Coder: Exam Prep (1 hour) This webinar provides an overview of the format and content of the CMC examination and includes discussion of common pitfalls as well as helpful hints. On-site MedDRA training: All of the above listed topics are available for on-site presentation. Course material can also be customized to your organization s specification. 12 analysis and retrieval of MedDRA-encoded data. This course focuses on the use of MedDRA to retrieve and present aggregated data, based on the principles outlined in the MedDRA Data Retrieval and Presentation: Points to Consider document. A few real-life examples and hands-on query development exercises are included. This course also includes a thorough overview of Standardised MedDRA Queries (SMQs) and their application in the investigation of drug safety issues. Participants learn about the development, testing and maintenance of SMQs and see detailed examples of individual SMQs. Examples of practical applications of SMQs for case identification and safety signal detection are presented. Who Should Attend? Drug safety/pharmacovigilance professionals, medical writers, and clinical safety professionals. Medication Error and Product Quality Issue Concepts in MedDRA (1.5 hours) This webinar presentation provides a brief background introduction to the inclusion of medication error and product quality issue concepts in MedDRA and focuses on their definitions and concept descriptions. Practical examples and approaches to coding and analyzing both medication errors and product quality issues are included. MedDRA Version Updates (1.5 hours) This webinar provides an overview of the background and rationale for versioning and describes the resources available to assist with updates. The timing of updates for both clinical trials and single case reports will be discussed together with the various recoding options defining the extent of an update. The impact of updates on coding and analysis within organizations will be described using practical examples. What s New with MedDRA (1 hour) The What s New with MedDRA webinars provide information on changes incorporated into each new version release. Sessions are scheduled to coincide with the corresponding version release.