{"title":"R3 Training","description":"","products":[{"product_id":"good-clinical-practice-a-question-answer-reference-guide-2024-2025-electronic","title":"Good Clinical Practice: A Question \u0026 Answer Reference Guide 2024\/2025 (Electronic)","description":"\u003cp\u003e \u003c\/p\u003e\n\u003cdiv class=\"leftColumn\"\u003e\u003cbr\u003e\u003c\/div\u003e\n\u003cdiv class=\"publicationContent\"\u003e\n\u003cp class=\"Abstract\"\u003e\u003ca href=\"https:\/\/stage.barnettinternational.com\/docs\/librariesprovider43\/default-document-library\/gcp-toc.pdf?sfvrsn=b5f4e482_1\"\u003eView the Table of Contents\u003c\/a\u003e\u003c\/p\u003e\n\u003chr style=\"border-top: 3px solid #212c65;\"\u003e\n\u003cp\u003e\u003cimg class=\"imageResize\" alt=\"Interview Spotlight\" src=\"https:\/\/stage.barnettinternational.com\/images\/librariesprovider43\/publications\/interview-spotlight.jpg?sfvrsn=2919dec1_1\"\u003e\u003c\/p\u003e\n\u003cp\u003eHear a conversation between \u003cb\u003eEditor-in-Chief, Donna W. Dorozinsky, R.N., M.S.N., C.C.R.C. and Keith Dorricott\u003c\/b\u003e, as they discuss Risk-Based Quality Management and share insights from the Good Clinical Practice: A Question \u0026amp; Answer Reference Guide on this important topic.\u003c\/p\u003e\n\u003c!-- START VideoEmbed --\u003e\n\u003cdiv class=\"row\"\u003e\n\u003cdiv class=\"col-sm-6\" style=\"width:auto; margin: 10px 0;\"\u003e\n\u003cdiv class=\"videoWrapper\"\u003e\u003ciframe title=\"YouTube video player\" src=\"https:\/\/www.youtube.com\/embed\/H540fRQ8ers?rel=0\" height=\"315\" width=\"560\"\u003e\u003c\/iframe\u003e\u003c\/div\u003e\n\u003c\/div\u003e\n\u003c\/div\u003e\n\u003c!--END  VideoEmbed --\u003e\n\u003cp\u003e \u003c\/p\u003e\n\u003cp\u003eListen to an Interview with \u003cb\u003eRob DiCicco, VP Portfolio Management, Transcelerate Biopharma Inc. and Editor-in-Chief, Donna W. Dorozinsky, R.N., M.S.N., C.C.R.C.\u003c\/b\u003e, as she discusses what's new in this edition, including new chapters, integrated global content, and our expert editorial team.\u003c\/p\u003e\n\u003c!-- START VideoEmbed --\u003e\n\u003cdiv class=\"row\"\u003e\n\u003cdiv class=\"col-sm-6\" style=\"width:auto; margin: 10px 0;\"\u003e\n\u003cdiv class=\"videoWrapper\"\u003e\u003ciframe title=\"YouTube video player\" src=\"https:\/\/www.youtube.com\/embed\/6J-l5DfPRX8?rel=0\" height=\"315\" width=\"560\"\u003e\u003c\/iframe\u003e\u003c\/div\u003e\n\u003c\/div\u003e\n\u003c\/div\u003e\n\u003c!--END  VideoEmbed --\u003e\u003chr style=\"border-top: 3px solid #212c65;\"\u003e\n\u003cp style=\"text-align: left;\" class=\"Abstract pad-top\"\u003eIn the past several years we have seen the release of many new regulations and guidances throughout the world. We have come out of a pandemic which has changed how we conduct and manage clinical trials, and we are dealing with an unstable world where research subjects are living in war torn regions. The 2024\/2025 edition of Barnett’s Good Clinical Practice: A Question \u0026amp; Answer Reference Guide has been reorganized with added topics to address this new era of clinical research. Written by more than 20 subject matter experts in core clinical research areas, this industry-leading GCP reference guide answers over 1,500 of the most common and difficult questions regarding the interpretation and implementation of U.S. and international GCP standards for drugs, biologics, and medical device clinical trials.\u003cspan style=\"font-family: inherit;\"\u003e \u003c\/span\u003e\u003c\/p\u003e\n\u003cdiv\u003e\n\u003cp\u003e\u003cb style=\"background-color: transparent; color: inherit; font-size: inherit; text-align: inherit; text-transform: inherit; word-spacing: normal; caret-color: auto; white-space: inherit;\"\u003eSome highlights of the completely updated and expanded guide include:\u003c\/b\u003e\u003c\/p\u003e\n\u003c\/div\u003e\n\u003c\/div\u003e\n\u003cdiv class=\"publicationContent\"\u003e\n\u003cdiv style=\"margin-left: 2em;\" class=\"Abstract\"\u003e\n\u003cul\u003e\n\u003cli\u003eAn all-new section on risk-based quality management (RBQM) and Quality by Design, which are receiving ever more emphasis from global regulators\u003c\/li\u003e\n\u003cli\u003eEmphasis on Quality Tolerance Limits (QTLs), Key Risk Indicators (KRIs) and approaches to outsourcing RBQM\u003c\/li\u003e\n\u003cli\u003eUpdates specific to ICH E6 and E8 including the ICH E6 (R3) Draft\u003c\/li\u003e\n\u003cli\u003ePublic comments from regulators and references to other industry guidance\/sources\u003c\/li\u003e\n\u003cli\u003eImpact of the new Clinical Trial Regulations in the EU and how Clinical Trial Information System (CTIS) are used for SUSAR reporting in Europe\u003c\/li\u003e\n\u003cli\u003eContent covering Decentralized Clinical Trials (DCTs) and what evidence regulators require for data quality\u003c\/li\u003e\n\u003cli\u003eQuestions and answers regarding the balancing of equity and equality in trials (including study design, patient recruitment, compensation structures)\u003c\/li\u003e\n\u003cli\u003eDetails around the use of real-time data monitoring and participant engagement technologies and their ethical implications\u003c\/li\u003e\n\u003cli\u003eA new section on conducting a clinical trial during a pandemic and\/or war including trial management, risk assessments, monitoring activities, investigational product management, informed consent, and site change considerations\u003c\/li\u003e\n\u003cli\u003eAnd much more…!\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003c\/div\u003e\n\u003c\/div\u003e","brand":"dynamicProvider2","offers":[{"title":"Commercial","offer_id":52144029663597,"sku":"GCP24E","price":129.0,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0924\/7961\/9437\/files\/2026_GCP-Q_A_400x514_5928a301-f9e1-4d7b-a3db-6672e587490b.jpg?v=1758091757"},{"product_id":"ich-gcp-e6-r3-updates-implementing-risk-management-approaches-for-compliance-2027-01-28","title":"ICH GCP E6 (R3) Updates: Implementing Risk Management Approaches for Compliance","description":"\u003cp\u003e\u003c\/p\u003e\u003cp class=\"header-block-grey\"\u003eCourse Description\u003c\/p\u003e\u003cp\u003eThe ICH GCP E6(R3) updates introduce a refined, standardized approach\nto risk management that builds on previous revisions. A key shift in the\nupdated guidelines is the emphasis on a comprehensive, risk-based\napproach to quality management, with a clear focus on critical process\nand data identification, risk evaluation, and mitigation strategies. While\nRisk-Based Quality Management (RBQM) is now standard practice, the R3\nrevision also ensures that risk assessment and mitigation plans are required\nacross all clinical trials, regardless of RBQM adoption. This web seminar\nwill explore these updated requirements, focusing on risk management\nprinciples, including risk identification, evaluation, control, and reporting.\nPractical strategies for implementing the updated guidelines, along with\nstep-by-step methodologies for risk management, will be provided.\u003c\/p\u003e\u003cp class=\"header-block-grey\"\u003eLearning Objectives\u003c\/p\u003e\u003cul type=\"disc\"\u003e\n\u003cli\u003eDefine the three-way risk evaluation methodology introduced in the ICH GCP E6(R3) update\u003c\/li\u003e\n\u003cli\u003eDistinguish between risk mitigation and risk acceptance, and understand their application in clinical trials\u003c\/li\u003e\n\u003cli\u003eDescribe the concept of “predefined tolerance limits” as part of risk-based management\u003c\/li\u003e\n\u003cli\u003eExplain the role of centralized monitoring in risk management and quality assurance\u003c\/li\u003e\n\u003cli\u003eDevelop a best practice implementation process for risk management based on practical experience\u003c\/li\u003e\n\u003c\/ul\u003e\u003cp class=\"header-block-grey\"\u003eWho Should Attend\u003c\/p\u003e\u003cul type=\"disc\"\u003e\n\u003cli\u003eManagers\/Directors: Clinical Operations, Clinical\n        Research, Data Management, Quality Management, Compliance, Process\n        Improvement, Risk Management, Quality Risk Management\u003c\/li\u003e\n\u003cli\u003eStudy Managers\/Project Managers, CRAs\/Monitors (Centralized, On-site)\u003c\/li\u003e\n\u003cli\u003eBusiness Process Owners\u003c\/li\u003e\n\u003c\/ul\u003e\u003cp class=\"header-block-grey\"\u003eInstructor\u003c\/p\u003e\u003cp class=\"bold-italic\"\u003e\u003cb\u003e\u003ci\u003eThe course will be led by one of the following\n            instructors:\u003c\/i\u003e\u003c\/b\u003e\u003c\/p\u003e\u003cp\u003eNikki Christison, B.S., C.C.R.A., T.I.A.C.R.\u003c\/p\u003e\u003cp\u003eSusan M. Leister, M.B.A., Ph.D., CQA, CSSBB\u003c\/p\u003e\u003cp\u003eShelia Russell McCullers, M.S., D.M.\u003c\/p\u003e\u003cp\u003e\u003cspan class=\"purple-link\"\u003e\u003ca href=\"pages\/instructor-biographies\" title=\"Click here for complete trainer biographies\"\u003eClick here for complete trainer\n            biographies\u003c\/a\u003e\u003c\/span\u003e\u003c\/p\u003e\u003cp class=\"header-block-grey\"\u003eRegistration Fees\u003c\/p\u003e\u003cp\u003e$835*\u003c\/p\u003e\u003cp\u003e*Includes up to 20 participants per login at a single location. All participants (up to 20) are eligible for “Certificates of Attendance,” and accreditation, provided that accreditation requirements are met. For groups larger than 20 or for additional logins for other locations, please call +1 781.972.5400 or toll-free in the U.S. 800.856.2556, or email customer.service@barnettinternational.com for pricing.\u003c\/p\u003e\u003cp class=\"header-block-grey\"\u003eAccreditation Information\u003c\/p\u003e\u003cp\u003eBarnett International is accredited by the\n    Accreditation Council for Pharmacy Education as a provider of continuing\n    pharmacy education.  Participants will\n    receive 2.5 hours (0.25 CEUs) of continuing education credit for full\n    participation, including the completion of a pre-test, post-test, and program\n    evaluation.  Barnett International will\n    issue a receipt of completion for earned CEUs within three weeks of program\n    completion.  ACPE#: 0778-0000-25-033-L99-P.\n    Released: 4\/25. \u003c\/p\u003e\u003cp align=\"center\"\u003e\u003cspan class=\"bold\"\u003eHold\n this course at your company! For more information, contact Naila Ganatra at +1\n        215.413.2471. \u003c\/span\u003e\u003c\/p\u003e","brand":"Barnett International","offers":[{"title":"Commercial","offer_id":53474477375853,"sku":"BI17649","price":835.0,"currency_code":"USD","in_stock":true}]},{"product_id":"ich-gcp-e6-r3-updates-overview-of-changes-impacting-sponsors-cros-and-clinical-investigators-sites-2027-01-27","title":"ICH GCP E6 (R3) Updates: Overview of Changes Impacting Sponsors, CROs, and Clinical Investigators\/Sites","description":"\u003cp class=\"header-block-grey\"\u003eCourse Description\u003c\/p\u003e\u003cp\u003eThe release of ICH GCP E6(R3) marks a significant update to the previous versions of the guidelines, reflecting a more flexible, risk-based approach to clinical trial management. This revision enhances the framework for clinical trial design, conduct, oversight, and reporting, with an emphasis on improving trial efficiency, data integrity, and the protection of human subjects. The R3 update also refines roles and responsibilities for sponsors, CROs, and clinical investigators\/sites, aligning them with current best practices and regulatory expectations. This web seminar will provide an overview of the key updates in ICH GCP E6(R3), including new definitions, sponsor\/CRO and investigator responsibilities, and essential documents. We will also explore how these updates influence clinical trial processes and provide practical guidance on how to implement these changes within your organization.\u003c\/p\u003e\u003cp class=\"header-block-grey\"\u003eLearning Objectives\u003c\/p\u003e\u003cul type=\"disc\"\u003e \u003cli\u003eExplain the rationale behind the ICH GCP E6 R2 and R3 updates, and their intended impact on clinical trial management\u003c\/li\u003e \u003cli\u003eDescribe the key terms and definitions that were introduced or updated in the ICH GCP E6(R3)\u003c\/li\u003e \u003cli\u003eIdentify the specific changes in the ICH GCP E6(R3) update and proposed updates impacting sponsors, CROs, and clinical investigators\/sites\u003c\/li\u003e \u003cli\u003eRecognize the significance of these changes for sponsor\/CRO and investigator\/site responsibilities, and their potential impact on clinical trial conduct\u003c\/li\u003e \u003c\/ul\u003e\u003cp class=\"header-block-grey\"\u003eWho Should Attend\u003c\/p\u003e\u003cul type=\"disc\"\u003e \u003cli\u003eManagers\/Directors: Clinical Operations, Clinical Research, Quality Management, Compliance\u003c\/li\u003e \u003cli\u003eStudy Managers, Project Managers\u003c\/li\u003e \u003cli\u003eClinical Research Associates\/Monitors\u003c\/li\u003e \u003cli\u003eQuality Assurance Personnel\u003c\/li\u003e \u003c\/ul\u003e\u003cp class=\"header-block-grey\"\u003eInstructor\u003c\/p\u003e\u003cp class=\"bold-italic\"\u003e\u003cb\u003e\u003ci\u003eThe course will be led by one of the following instructors:\u003c\/i\u003e\u003c\/b\u003e \u003c\/p\u003e\u003cp\u003eNikki Christison, B.S., C.C.R.A., T.I.A.C.R.\u003c\/p\u003e\u003cp\u003eSusan M. Leister, M.B.A., Ph.D., CQA, CSSBB\u003c\/p\u003e\u003cp\u003eShelia Russell McCullers, M.S., D.M.\u003c\/p\u003e\u003cp\u003e\u003cspan class=\"purple-link\"\u003e\u003ca href=\"https:\/\/stage.barnettinternational.com\/instructor-biographies\" title=\"Click here for complete trainer biographies\"\u003eClick here for complete trainer biographies\u003c\/a\u003e\u003c\/span\u003e\u003c\/p\u003e\u003cp class=\"header-block-grey\"\u003eRegistration Fees\u003c\/p\u003e\u003cp\u003e$835*\u003c\/p\u003e\u003cp\u003e*Includes up to 20 participants per login at a single location. All participants (up to 20) are eligible for \"Certificates of Attendance,\" and accreditation, provided that accreditation requirements are met. For groups larger than 20 or for additional logins for other locations, please call +1 781.972.5400 or toll-free in the U.S. 800.856.2556, or email customer.service@barnettinternational.com for pricing.\u003c\/p\u003e\u003cp class=\"header-block-grey\"\u003eAccreditation Information\u003c\/p\u003e\u003cp\u003eBarnett International is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. Participants will receive 2.5 hours (0.25 CEUs) of continuing education credit for full participation, including the completion of a pre-test, post-test, and program evaluation. Barnett International will issue a receipt of completion for earned CEUs within three weeks of program completion. ACPE#: 0778-0000-25-034-L04-P. Released: 4\/25. \u003c\/p\u003e\u003cp align=\"center\"\u003e\u003cspan class=\"bold\"\u003eHold this course at your company! For more information, contact Naila Ganatra at +1 215.413.2471. \u003c\/span\u003e\u003c\/p\u003e","brand":"Barnett International","offers":[{"title":"Commercial","offer_id":53474478195053,"sku":"BI17646","price":835.0,"currency_code":"USD","in_stock":true}]},{"product_id":"ich-gcp-e6-r3-updates-sponsor-quality-management-risk-based-risk-management-requirements-and-approaches-for-compliance-2027-01-21","title":"ICH GCP E6 (R3) Updates: Sponsor Quality Management - Risk-Based\/Risk Management Requirements and Approaches for Compliance","description":"\u003cp class=\"header-block-grey\"\u003eCourse Description\u003c\/p\u003e\u003cp\u003eThe ICH GCP E6(R3) update refines the focus on quality management in clinical trials, shifting towards a more structured and risk-based approach to trial oversight. Building on the previous guidance from E6 R2, the R3 revision emphasizes the importance of a Clinical Quality Management System (cQMS) to ensure quality throughout the entire clinical trial lifecycle-from design through to archiving. This web seminar will explore the sponsor's responsibilities in implementing and maintaining a risk-based quality management system, highlighting new requirements introduced in E6(R3). Industry benchmarks, standards, and best practices for establishing cQMS, as well as practical approaches to achieve compliance will also be covered. Additionally, the web seminar will address the implications of the R3 updates, including how these changes influence risk management and trial quality oversight.\u003c\/p\u003e\u003cp class=\"header-block-grey\"\u003eLearning Objectives\u003c\/p\u003e\u003cul type=\"disc\"\u003e \u003cli\u003eDescribe two new requirements for sponsor quality management (QM) in clinical trials as outlined in ICH GCP E6(R3)\u003c\/li\u003e \u003cli\u003eIdentify two risk-based approaches to achieving compliance with QM throughout the clinical trial lifecycle\u003c\/li\u003e \u003cli\u003eDetermine next steps for evaluating and implementing the new quality management requirements in clinical trials\u003c\/li\u003e \u003c\/ul\u003e\u003cp class=\"header-block-grey\"\u003eWho Should Attend\u003c\/p\u003e\u003cul type=\"disc\"\u003e \u003cli\u003eTrial Managers\u003c\/li\u003e \u003cli\u003eProject Managers\/Directors\u003c\/li\u003e \u003cli\u003eClinical Quality Assurance\/Compliance Personnel\u003c\/li\u003e \u003c\/ul\u003e\u003cp class=\"header-block-grey\"\u003eInstructor\u003c\/p\u003e\u003cp class=\"bold-italic\"\u003e\u003cb\u003e\u003ci\u003eThe course will be led by one of the following instructors:\u003c\/i\u003e\u003c\/b\u003e\u003c\/p\u003e\u003cp\u003eNikki Christison, B.S., C.C.R.A.,T.I.A.C.R.\u003c\/p\u003e\u003cp\u003eSusan M. Leister, M.B.A., Ph.D., CQA, CSSBB\u003c\/p\u003e\u003cp\u003eShelia Russell McCullers, M.S., D.M.\u003c\/p\u003e\u003cp\u003e\u003ca href=\"https:\/\/stage.barnettinternational.com\/instructor-biographies\" title=\"Click here for complete trainer biographies\" style=\"font-family:inherit;font-size:inherit;text-align:inherit;text-transform:inherit;word-spacing:normal;white-space:inherit;\"\u003eClick here for complete trainer biographies\u003c\/a\u003e\u003c\/p\u003e\u003cp class=\"header-block-grey\"\u003eRegistration Fees\u003c\/p\u003e\u003cp\u003e$835*\u003c\/p\u003e\u003cp\u003e*Includes up to 20 participants per login at a single location. All participants (up to 20) are eligible for \"Certificates of Attendance,\" and accreditation, provided that accreditation requirements are met. For groups larger than 20 or for additional logins for other locations, please call +1 781.972.5400 or toll-free in the U.S. 800.856.2556, or email customer.service@barnettinternational.com for pricing.\u003c\/p\u003e\u003cp class=\"header-block-grey\"\u003eAccreditation Information\u003c\/p\u003e\u003cp\u003eBarnett International is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. Participants will receive 2 hours (0.2 CEUs) of continuing education credit for full participation, including the completion of a pre-test, post-test, and program evaluation. Barnett International will issue a receipt of completion for earned CEUs within three weeks of program completion. ACPE#: 0778-0000-25-035-L99-P. Released: 2\/25. \u003c\/p\u003e\u003cp align=\"center\"\u003e\u003cspan class=\"bold\"\u003eHold this course at your company! For more information, contact Naila Ganatra at +1 215.413.2471. \u003c\/span\u003e\u003c\/p\u003e","brand":"Barnett International","offers":[{"title":"Commercial","offer_id":53474478522733,"sku":"BI17634","price":835.0,"currency_code":"USD","in_stock":true}]},{"product_id":"ich-gcp-e6-r3-updates-key-changes-impacting-sponsors-and-cros-2027-01-20","title":"ICH GCP E6 (R3) Updates: Key Changes Impacting Sponsors and CROs","description":"\u003cp class=\"header-block-grey\"\u003eCourse Description\u003c\/p\u003e\u003cp\u003eThe release of ICH GCP E6(R3) represents a significant evolution in clinical trial management, building on the changes introduced in the R2 revision. With a focus on improving efficiency and adaptability in the face of growing trial complexity, the R3 updates bring more flexible and risk-based approaches to trial design, conduct, and oversight. This web seminar will guide participants through the essential updates in the ICH E6 guidelines, highlighting the direct impact on sponsors, CROs, and clinical trial teams. Practical strategies for incorporating these revisions into trial management processes will be explored, along with insights into how the R3 updates can streamline operational workflows while maintaining high standards of quality and compliance. Specific topics include the evolving roles of sponsors and CROs in this updated framework.\u003c\/p\u003e\u003cp class=\"header-block-grey\"\u003eLearning Objectives\u003c\/p\u003e\u003cul type=\"disc\"\u003e \u003cli\u003eIdentify three key changes in the ICH GCP E6(R3) updates that affect sponsors and CROs, along with their impact on individual roles\u003c\/li\u003e \u003cli\u003eExplain how the revisions influence clinical trial conduct and organizational practices\u003c\/li\u003e \u003cli\u003eDiscuss practical opportunities for implementing the revised guideline to improve trial management efficiency and compliance\u003c\/li\u003e \u003c\/ul\u003e\u003cp class=\"header-block-grey\"\u003eWho Should Attend\u003c\/p\u003e\u003cul type=\"disc\"\u003e \u003cli\u003eManagers\/Directors: Clinical Operations, Clinical Research, Data Management, Quality Management, Compliance, Process Improvement, Risk Management, Quality Risk Management \u003c\/li\u003e \u003cli\u003eStudy Managers\/Project Managers, Clinical Research Associates\/ Monitors (Centralized, On-site) \u003c\/li\u003e \u003c\/ul\u003e\u003cp class=\"header-block-grey\"\u003eInstructor\u003c\/p\u003e\u003cp class=\"bold-italic\"\u003e\u003cb\u003e\u003ci\u003eThe course will be led by one of the following instructors:\u003c\/i\u003e\u003c\/b\u003e \u003c\/p\u003e\u003cp\u003eNikki Christison, B.S., C.C.R.A., T.I.A.C.R.\u003c\/p\u003e\u003cdiv\u003e \u003cp\u003eSusan M. Leister, M.B.A., Ph.D., CQA, CSSBB\u003c\/p\u003e \u003cp\u003eShelia Russell \u003cfont face=\"inherit\" size=\"-1\"\u003eMcCullers, M.S., D.M.\u003c\/font\u003e \u003c\/p\u003e \u003c\/div\u003e\u003cp\u003e\u003ca href=\"https:\/\/stage.barnettinternational.com\/instructor-biographies\" title=\"Click here for complete trainer biographies\" style=\"font-family:inherit;font-size:inherit;text-align:inherit;text-transform:inherit;word-spacing:normal;white-space:inherit;\"\u003eClick here for complete trainer biographies\u003c\/a\u003e\u003c\/p\u003e\u003cp class=\"header-block-grey\"\u003eRegistration Fees\u003c\/p\u003e\u003cp\u003e$835*\u003c\/p\u003e\u003cp\u003e*Includes up to 20 participants per login at a single location. All participants (up to 20) are eligible for \"Certificates of Attendance,\" and accreditation, provided that accreditation requirements are met. For groups larger than 20 or for additional logins for other locations, please call +1 781.972.5400 or toll-free in the U.S. 800.856.2556, or email customer.service@barnettinternational.com for pricing.\u003c\/p\u003e\u003cp class=\"header-block-grey\"\u003eAccreditation Information\u003c\/p\u003e\u003cp\u003eBarnett International is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. Participants will receive 2 hours (0.2 CEUs) of continuing education credit for full participation, including the completion of a pre-test, post-test, and program evaluation. Barnett International will issue a receipt of completion for earned CEUs within three weeks of program completion. ACPE#:0778-0000-25-031-L99-P. Released: 4\/25. \u003c\/p\u003e\u003cp align=\"center\"\u003e\u003cspan class=\"bold\"\u003eHold this course at your company! For more information, contact Naila Ganatra at +1 215.413.2471. \u003c\/span\u003e\u003c\/p\u003e","brand":"Barnett International","offers":[{"title":"Commercial","offer_id":53474477965677,"sku":"BI17631","price":835.0,"currency_code":"USD","in_stock":true}]},{"product_id":"ich-gcp-e6-r3-updates-key-changes-impacting-clinical-investigators-sites-and-ind-holders-sponsor-investigators-and-institutions-2027-01-11","title":"ICH GCP E6 (R3) Updates: Key Changes Impacting Clinical Investigators, Sites, and IND Holders (Sponsor-Investigators and Institutions)","description":"\u003cp class=\"header-block-grey\"\u003eCourse Description\u003c\/p\u003e\u003cp\u003eThe ICH GCP E6(R3) update introduces significant advancements to clinical trial management, emphasizing flexibility, efficiency, and risk-based approaches. This revision refines key areas such as investigator responsibilities, quality management, and trial oversight to better align with the complexities of modern clinical research. This web seminar will provide an in-depth look at the changes brought about by the R3 update, focusing on their impact on clinical investigators, trial sites, and Sponsors-Investigators. Topics will include the expanded responsibilities of investigators, sponsors, and institutions regarding oversight, monitoring plans, risk assessments, and data integrity. Learners will also explore practical strategies for updating organizational SOPs, processes, and staff training to ensure compliance with the new guidelines.\u003c\/p\u003e\u003cp class=\"header-block-grey\"\u003eLearning Objectives\u003c\/p\u003e\u003cul type=\"disc\"\u003e \u003cli\u003eIdentify key changes affecting investigator responsibilities and roles under the ICH GCP E6(R3) guidelines\u003c\/li\u003e \u003cli\u003eExplain how the revisions impact clinical trial sites and Sponsors-Investigators\u003c\/li\u003e \u003cli\u003eEvaluate potential solutions for adapting organizational SOPs, processes, procedures, and staff training to the updated guidelines\u003c\/li\u003e \u003cli\u003eApply best practices for effective implementation of the ICH GCP E6(R3) guidelines in clinical trials\u003c\/li\u003e \u003c\/ul\u003e\u003cp class=\"header-block-grey\"\u003eWho Should Attend\u003c\/p\u003e\u003cul type=\"disc\"\u003e \u003cli\u003eQuality Assurance\/Compliance Personnel\u003c\/li\u003e \u003cli\u003ePrincipal Investigators\/Sub-Investigators\u003c\/li\u003e \u003cli\u003eResearch Site Staff (Managers, CRCs, Data Managers\/Data Entry)\u003c\/li\u003e \u003cli\u003eManagers\/Directors: Clinical Operations, Clinical Research, Data Management, Quality Management, Compliance, Process Improvement, Risk Management, Quality Risk Management\u003c\/li\u003e \u003cli\u003eStudy Managers\/Project Managers, CRAs\/Monitors (Centralized, On-site)\u003c\/li\u003e \u003c\/ul\u003e\u003cp class=\"header-block-grey\"\u003eInstructor\u003c\/p\u003e\u003cp class=\"bold-italic\"\u003e\u003cb\u003e\u003ci\u003eThe course will be led by one of the following instructors:\u003c\/i\u003e\u003c\/b\u003e\u003c\/p\u003e\u003cp\u003eNikki Christison, B.S., C.C.R.A., T.I.A.C.R.\u003c\/p\u003e\u003cp\u003eSusan M. Leister, M.B.A., Ph.D., CQA, CSSBB\u003c\/p\u003e\u003cp\u003eShelia Russell McCullers, M.S., D.M.\u003c\/p\u003e\u003cp\u003e\u003cspan class=\"purple-link\"\u003e\u003ca href=\"https:\/\/stage.barnettinternational.com\/instructor-biographies\" title=\"Click here for complete trainer biographies\"\u003eClick here for complete trainer biographies\u003c\/a\u003e\u003c\/span\u003e\u003c\/p\u003e\u003cp class=\"header-block-grey\"\u003eRegistration Fees\u003c\/p\u003e\u003cp\u003e$835*\u003c\/p\u003e\u003cp\u003e*Includes up to 20 participants per login at a single location. All participants (up to 20) are eligible for \"Certificates of Attendance,\" and accreditation, provided that accreditation requirements are met. For groups larger than 20 or for additional logins for other locations, please call +1 781.972.5400 or toll-free in the U.S. 800.856.2556, or email customer.service@barnettinternational.com for pricing.\u003c\/p\u003e\u003cp class=\"header-block-grey\"\u003eAccreditation Information\u003c\/p\u003e\u003cp\u003eBarnett International is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. Participants will receive 2 hours (0.2 CEUs) of continuing education credit for full participation, including the completion of a pre-test, post-test, and program evaluation. Barnett International will issue a receipt of completion for earned CEUs within three weeks of program completion. ACPE#: 0778-0000-25-030-L99-P. Released: 4\/25. \u003c\/p\u003e\u003cp align=\"center\"\u003e\u003cspan class=\"bold\"\u003eHold this course at your company! For more information, contact Naila Ganatra at +1 215.413.2471.\u003c\/span\u003e\u003c\/p\u003e","brand":"Barnett International","offers":[{"title":"Commercial","offer_id":53474477670765,"sku":"BI17618","price":835.0,"currency_code":"USD","in_stock":true}]},{"product_id":"understanding-ich-e6-r3-gcp-updates-key-changes-from-r2-2026-12-15","title":"Understanding ICH E6 (R3) (GCP) Updates: Key Changes from R2","description":"\u003cp class=\"header-block-grey\"\u003eCourse Description\u003c\/p\u003e\u003cp\u003eThe ICH announced an update to GCP guidelines following the release of ICH E6(R2). After eight years, ICH E6(R3) has now been launched, reflecting the modernization needed to align with the evolving clinical development landscape. Along with ICH E8(R1), this update sets the stage for addressing future challenges. The revised guidelines bring both significant conceptual shifts and smaller updates aimed at streamlining the clinical trial process. Many of these updates will be well received across the industry, though some new challenges will need to be navigated. The changes in ICH E8(R1) and their direct impact on ICH E6(R3) will also be examined. \u003c\/p\u003e\u003cp class=\"header-block-grey\"\u003eLearning Objectives\u003c\/p\u003e\u003cul type=\"disc\"\u003e \u003cli\u003eLearn about the regulatory context behind the changes\u003c\/li\u003e \u003cli\u003eUnderstand the key goals of ICH E6(R3)\u003c\/li\u003e \u003cli\u003eCompare ICH E6(R3) with ICH E6(R2) and identify the major differences\u003c\/li\u003e \u003cli\u003eGain an introduction to Quality by Design and its role in clinical development\u003c\/li\u003e \u003cli\u003eUnderstand the impact of risk management and quality measures in Quality by Design\u003c\/li\u003e \u003c\/ul\u003e\u003cp class=\"header-block-grey\"\u003eWho Should Attend\u003c\/p\u003e\u003cul type=\"disc\"\u003e \u003cli\u003eClinical Operations, Onsite Operations, Data Management, and Statistics Managers\u003c\/li\u003e \u003cli\u003eRegulatory Professionals\u003c\/li\u003e \u003cli\u003ePharmacovigilance Teams\u003c\/li\u003e \u003c\/ul\u003e\u003cp class=\"header-block-grey\"\u003eInstructor\u003c\/p\u003e\u003cp\u003eAndy Lawton\u003c\/p\u003e\u003cp\u003e\u003cspan class=\"purple-link\"\u003e\u003ca href=\"https:\/\/www.barnettinternational.com\/instructor-biographies\" title=\"Click here for complete trainer biographies\"\u003eClick here for complete trainer biographies\u003c\/a\u003e\u003c\/span\u003e\u003c\/p\u003e\u003cp class=\"header-block-grey\"\u003eRegistration Fees\u003c\/p\u003e\u003cp\u003e$835*\u003c\/p\u003e\u003cp\u003e*Includes up to 20 participants per login at a single location. All participants (up to 20) are eligible for \"Certificates of Attendance,\" and accreditation, provided that accreditation requirements are met. For groups larger than 20 or for additional logins for other locations, please call +1 781.972.5400 or toll-free in the U.S. 800.856.2556, or email customer.service@barnettinternational.com for pricing.\u003c\/p\u003e\u003cp class=\"header-block-grey\"\u003eAccreditation Information\u003c\/p\u003e\u003cp\u003eBarnett International is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. Participants will receive 2 hours (0.2 CEUs) of continuing education credit for full participation, including the completion of a pre-test, post-test, and program evaluation. Barnett International will issue a receipt of completion for earned CEUs within three weeks of program completion. ACPE#: 0778-0000-25-037-L99-P. Released: 3\/25. \u003c\/p\u003e\u003cp align=\"center\"\u003e\u003cspan class=\"bold\"\u003eHold this course at your company! For more information, contact Naila Ganatra at +1 215.413.2471.\u003c\/span\u003e\u003c\/p\u003e","brand":"Barnett International","offers":[{"title":"Commercial","offer_id":53474495267181,"sku":"BI17592","price":835.0,"currency_code":"USD","in_stock":true}]},{"product_id":"ich-e8-r1-changes-impacting-sponsors-cros-2026-12-09","title":"ICH E8 (R1): Changes Impacting Sponsors\/CROs","description":"\u003cp class=\"header-block-grey\"\u003eCourse Description\u003c\/p\u003e\u003cp\u003eThe ICH E8(R1) revision is intended to identify and modernize the current conduct of clinical research: Clinical trial design, planning, management, and conduct. The goal of the updated ICH E8(R1) guidance is to provide flexibility in addressing the increasing diversity of study types and data sources that are being employed to support regulatory and other health policy decisions. This web seminar will describe the ICH E8(R1) addendum in a step-by-step process and provide a parallel discussion of how the reviewed guideline can improve efficient approaches to trial management. Discussion topics include: A Quality by Design (QbD) approach to the planning, development, and design of a clinical trial; stakeholder engagement during the design and conduct of clinical trials focusing on trial design, recruitment, retention of trial subjects; ethical concerns regarding access to medication post-trial; real-world evidence (RWE) in drug development post-market safety; working with various types of data sources; and the need to leverage more modern technology.\u003c\/p\u003e\u003cp class=\"header-block-grey\"\u003eLearning Objectives\u003c\/p\u003e\u003cul type=\"disc\"\u003e \u003cli\u003eDescribe the ICH E8(R1) guideline changes\u003c\/li\u003e \u003cli\u003eExplain the impact of the ICH E8(R1) on clinical trial conduct\u003c\/li\u003e \u003cli\u003eDiscuss opportunities for implementing the ICH E8(R1) guideline in your organization\u003c\/li\u003e \u003c\/ul\u003e\u003cp class=\"header-block-grey\"\u003eWho Should Attend\u003c\/p\u003e\u003cul type=\"disc\"\u003e \u003cli\u003eManagers\/Directors: Clinical Operations, Clinical Research, Data Management, Quality Management, Compliance, Process Improvement, Risk Management, Quality Risk Management\u003c\/li\u003e \u003cli\u003eStudy Managers\/Project Managers\u003c\/li\u003e \u003cli\u003eClinical Research Associates\/Monitors\u003c\/li\u003e \u003cli\u003eRegulatory Affairs\u003c\/li\u003e \u003cli\u003eBiostatisticians, Data Managers\u003c\/li\u003e \u003cli\u003eClinical Research Nurses, Clinical Research Coordinators, Clinical Investigators\u003c\/li\u003e \u003c\/ul\u003e\u003cp class=\"header-block-grey\"\u003eInstructor\u003c\/p\u003e\u003cp\u003eAndy Lawton\u003c\/p\u003e\u003cp\u003e\u003cspan class=\"purple-link\"\u003e\u003ca href=\"https:\/\/www.barnettinternational.com\/instructor-biographies\" title=\"Click here for complete trainer biographies\"\u003eClick here for complete trainer biographies\u003c\/a\u003e\u003c\/span\u003e\u003c\/p\u003e\u003cp class=\"header-block-grey\"\u003eRegistration Fees\u003c\/p\u003e\u003cp\u003e$735*\u003c\/p\u003e\u003cp\u003e*Includes up to 20 participants per login at a single location. All participants (up to 20) are eligible for \"Certificates of Attendance,\" and accreditation, provided that accreditation requirements are met. For groups larger than 20 or for additional logins for other locations, please call +1 781.972.5400 or toll-free in the U.S. 800.856.2556, or email customer.service@barnettinternational.com for pricing.\u003c\/p\u003e\u003cp class=\"header-block-grey\"\u003eAccreditation Information\u003c\/p\u003e\u003cp\u003eBarnett International is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. Participants will receive 2 hours (0.2 CEUs) of continuing education credit for full participation, including the completion of a pre-test, post-test, and program evaluation. Barnett International will issue a receipt of completion for earned CEUs within three weeks of program completion. ACPE#: 778-0000-23-058-L99-P. Released: 7\/23. \u003c\/p\u003e\u003cp align=\"center\"\u003e\u003cspan class=\"bold\"\u003eHold this course at your company! For more information, contact Naila Ganatra at +1 215.413.2471.\u003c\/span\u003e\u003c\/p\u003e","brand":"Barnett International","offers":[{"title":"Commercial","offer_id":53474476327277,"sku":"BI17580","price":735.0,"currency_code":"USD","in_stock":true}]},{"product_id":"ich-e8-r1-designing-quality-into-clinical-studies-2026-12-08","title":"ICH E8 (R1): Designing Quality into Clinical Studies","description":"\u003cp class=\"header-block-grey\"\u003eCourse Description\u003c\/p\u003e\u003cp\u003eICH E8(R1) is intended to identify and modernize the present conduct of clinical research, including clinical trial design, planning, management, and conduct. In clinical research, quality assurance activities of retrospective document checking, monitoring, auditing, or inspection are essential, and there has been an overreliance on these tasks versus relying on designing quality into clinical studies during development and throughout clinical research. This web seminar covers the importance of designing quality into clinical trials with a focus on Quality by Design (QbD) of clinical studies, critical factors to quality, essential identification of quality factors, establishing a culture that supports critical thinking and open dialogue regarding proactive quality versus reliance on tools\/checklists, and stakeholder engagement.\u003c\/p\u003e\u003cp class=\"header-block-grey\"\u003eLearning Objectives\u003c\/p\u003e\u003cul type=\"disc\"\u003e \u003cli\u003eDescribe ICH E8(R1): Designing Quality into Clinical Studies\u003c\/li\u003e \u003cli\u003eDefine critical factors to quality in ensuring human subject protection and generation of reliable and meaningful results\u003c\/li\u003e \u003cli\u003eIdentify an appropriate framework for the identification and review of essential elements of quality in clinical studies\u003c\/li\u003e \u003c\/ul\u003e\u003cp class=\"header-block-grey\"\u003eWho Should Attend\u003c\/p\u003e\u003cul type=\"disc\"\u003e \u003cli\u003eManagers\/Directors: Clinical Operations, Clinical Research, Data Management, Quality Management, Compliance, Process Improvement, Risk Management, Quality Risk Management\u003c\/li\u003e \u003cli\u003eStudy Managers\/Project Managers\u003c\/li\u003e \u003cli\u003eClinical Research Associates\/Monitors\u003c\/li\u003e \u003cli\u003eRegulatory Affairs Professionals \u003c\/li\u003e \u003cli\u003eBiostatisticians, Data Managers \u003c\/li\u003e \u003cli\u003eClinical Research Nurses, Clinical Research Coordinators, Clinical Investigators\u003c\/li\u003e \u003c\/ul\u003e\u003cp class=\"header-block-grey\"\u003eInstructor\u003c\/p\u003e\u003cp\u003eAndy Lawton\u003c\/p\u003e\u003cp\u003e\u003cspan class=\"purple-link\"\u003e\u003ca href=\"https:\/\/www.barnettinternational.com\/instructor-biographies\" title=\"Click here for complete trainer biographies\"\u003eClick here for complete trainer biographies\u003c\/a\u003e\u003c\/span\u003e\u003c\/p\u003e\u003cp class=\"header-block-grey\"\u003eRegistration Fees\u003c\/p\u003e\u003cp\u003e$735*\u003c\/p\u003e\u003cp\u003e*Includes up to 20 participants per login at a single location. All participants (up to 20) are eligible for \"Certificates of Attendance,\" and accreditation, provided that accreditation requirements are met. For groups larger than 20 or for additional logins for other locations, please call +1 781.972.5400 or toll-free in the U.S. 800.856.2556, or email customer.service@barnettinternational.com for pricing.\u003c\/p\u003e\u003cp class=\"header-block-grey\"\u003eAccreditation Information\u003c\/p\u003e\u003cp\u003eBarnett International is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. Participants will receive 2 hours (0.2 CEUs) of continuing education credit for full participation, including the completion of a pre-test, post-test, and program evaluation. Barnett International will issue a receipt of completion for earned CEUs within three weeks of program completion. ACPE#: 0778-0000-23-059-L99-P. Released: 7\/23. \u003cspan class=\"bold\"\u003e\u003c\/span\u003e \u003c\/p\u003e\u003cp align=\"center\"\u003e\u003cspan class=\"bold\"\u003eHold this course at your company! For more information, contact Naila Ganatra at +1 215.413.2471.\u003c\/span\u003e\u003c\/p\u003e","brand":"Barnett International","offers":[{"title":"Commercial","offer_id":53474476523885,"sku":"BI17578","price":735.0,"currency_code":"USD","in_stock":true}]},{"product_id":"implementing-quality-agreements-2026-12-02","title":"Implementing Quality Agreements","description":"\u003cp class=\"header-block-grey\"\u003eCourse Description\u003c\/p\u003e\u003cp\u003eQuality Agreements are a mainstay of the Good Manufacturing Practice (GMP) sphere as defined in ICH Q7 Section 16.12, and in Good Laboratory Practice (GLP) as inferred in 21 CFR Part 58.1 and 58.35. They have become more common in the Good Clinical Practice (GCP) arena of clinical trial operations as risk-based study management becomes firmly established. Quality Agreements delineate the quality expectations of both the sponsor and outsourced provider and are structured in a shared agreement. Web seminar participants will learn the purpose of, factors that are considered in, and explore possible content of Quality Agreements.\u003c\/p\u003e\u003cp class=\"header-block-grey\"\u003eLearning Objectives\u003c\/p\u003e\u003cul type=\"disc\"\u003e \u003cli\u003eDefine the purpose of a Quality Agreement\u003c\/li\u003e \u003cli\u003eExamine the differences between a Quality Agreement and a Contract for Services\u003c\/li\u003e \u003cli\u003eIdentify the critical factors that should be addressed in order to have an effective Quality Agreement\u003c\/li\u003e \u003cli\u003eEvaluate and determine who is responsible for developing Quality Agreements\u003c\/li\u003e \u003cli\u003eDetermine who is responsible for enforcing Quality Agreements\u003c\/li\u003e \u003cli\u003eStrategies for managing reticence from vendors about Quality Agreements\u003c\/li\u003e \u003cli\u003eDetermine when Quality Agreements should be developed and agreed upon\u003c\/li\u003e \u003cli\u003eExplore possible content of Quality Agreements\u003c\/li\u003e \u003c\/ul\u003e\u003cp class=\"header-block-grey\"\u003eWho Should Attend\u003c\/p\u003e\u003cul type=\"disc\"\u003e \u003cli\u003eManagers\/Directors: Clinical Operations, Quality Management, Compliance\u003c\/li\u003e \u003cli\u003eClinical Quality Assurance Professionals\u003c\/li\u003e \u003c\/ul\u003e\u003cp class=\"header-block-grey\"\u003eInstructor\u003c\/p\u003e\u003cp\u003eShana Zink, B.S., C.C.R.A.\u003c\/p\u003e\u003cp\u003e\u003cspan class=\"purple-link\"\u003e\u003ca href=\"\/pages\/instructor-biographies\" title=\"Click here for complete trainer biographies\"\u003eClick here for complete trainer biographies\u003c\/a\u003e\u003c\/span\u003e\u003c\/p\u003e\u003cp class=\"header-block-grey\"\u003eRegistration Fees\u003c\/p\u003e\u003cp\u003e$735*\u003c\/p\u003e\u003cp\u003e*Includes up to 20 participants per login at a single location. All participants (up to 20) are eligible for \"Certificates of Attendance,\" and accreditation, provided that accreditation requirements are met. For groups larger than 20 or for additional logins for other locations, please call +1 781.972.5400 or toll-free in the U.S. 800.856.2556, or email customer.service@barnettinternational.com for pricing.\u003c\/p\u003e\u003cp class=\"header-block-grey\"\u003eAccreditation Information\u003c\/p\u003e\u003cp\u003eBarnett International is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. Participants will receive 1.5 hours (0.15 CEUs) of continuing education credit for full participation, including the completion of a pre-test, post-test, and program evaluation. Barnett International will issue a receipt of completion for earned CEUs within three weeks of program completion. ACPE#: 0778-0000-24-052-L99-P. Released: 9\/24. \u003cspan class=\"bold\"\u003e\u003c\/span\u003e\u003c\/p\u003e\u003cp align=\"center\"\u003e\u003cspan class=\"bold\"\u003eHold this course at your company! For more information, contact Naila Ganatra at +1 215.413.2471. \u003c\/span\u003e\u003c\/p\u003e","brand":"Barnett International","offers":[{"title":"Commercial","offer_id":53474479014253,"sku":"BI17556","price":735.0,"currency_code":"USD","in_stock":true}]},{"product_id":"ich-e6-r3-and-ich-e8-r1-updates-impact-on-sponsors-2026-12-01","title":"ICH E6 (R3) and ICH E8 (R1) Updates: Impact on Sponsors","description":"\u003cp class=\"header-block-grey\"\u003eCourse Description\u003c\/p\u003e\u003cdiv\u003e\u003cp\u003eThe principles of GCP are designed to be flexible and applicable to a broad range of clinical trials. The updated E6 guideline, along with ICH E8, encourages thoughtful consideration and planning to address specific and potentially unique aspects of an individual clinical trial. This includes evaluation of trial characteristics, such as the design elements, the investigational product being evaluated, the medical condition being addressed, characteristics of the participants, the setting in which the clinical trial is being conducted, and the type of data being collected. Careful consideration of factors relevant to ensuring trial quality, including critical-to-quality (CTQ) factors, are needed for each clinical trial. This web seminar will provide a high-level overview of the drivers and changes planned for implementation.\u003cbr\u003e\u003c\/p\u003e\u003c\/div\u003e\u003cp class=\"header-block-grey\"\u003eLearning Objectives\u003c\/p\u003e\u003cul type=\"disc\"\u003e \u003cli\u003eIntroduce rationale, revisions, and release to ICH E6(R3)\u003c\/li\u003e \u003cli\u003eReview changes to principles in ICH E6(R3)\u003c\/li\u003e \u003cli\u003eIntroduce rationale, revisions, and release of E8\u003c\/li\u003e \u003cli\u003eReview CTQ factors that should be considered when planning a study\u003c\/li\u003e \u003cli\u003eDemonstrate that ICH E8 provides cross-referencing to other relevant ICH guidelines for planning and executing development program-related studies\u003c\/li\u003e \u003c\/ul\u003e\u003cp class=\"header-block-grey\"\u003eWho Should Attend\u003c\/p\u003e\u003cul type=\"disc\"\u003e \u003cli\u003eSenior Leaders, Directors, and Managers \u003c\/li\u003e \u003cli\u003eClinical Research Associates\u003c\/li\u003e \u003cli\u003eClinical Research Coordinators\u003c\/li\u003e \u003cli\u003eStudy Managers\u003c\/li\u003e \u003cli\u003eQuality Personnel\u003c\/li\u003e \u003cli\u003eData Managers\u003c\/li\u003e \u003cli\u003eBusiness Process Owners\u003c\/li\u003e \u003c\/ul\u003e\u003cp class=\"header-block-grey\"\u003eInstructor\u003c\/p\u003e\u003cp class=\"bold-italic\"\u003e\u003cb\u003e\u003ci\u003eThe course will be led by one of the following instructors:\u003c\/i\u003e\u003c\/b\u003e\u003c\/p\u003e\u003cp\u003eNikki Christison, B.S., C.C.R.A., T.I.A.C.R.\u003c\/p\u003e\u003cp\u003eSusan M. Leister, M.B.A., Ph.D., CQA, CSSBB\u003c\/p\u003e\u003cp\u003eShelia Russell McCullers, M.S., D.M.\u003c\/p\u003e\u003cp\u003e\u003cspan class=\"purple-link\"\u003e\u003ca href=\"https:\/\/stage.barnettinternational.com\/instructor-biographies\" title=\"Click here for complete trainer biographies\"\u003eClick here for complete trainer biographies\u003c\/a\u003e\u003c\/span\u003e\u003c\/p\u003e\u003cp class=\"header-block-grey\"\u003eRegistration Fees\u003c\/p\u003e\u003cp\u003e$735*\u003c\/p\u003e\u003cp\u003e*Includes up to 20 participants per login at a single location. All participants (up to 20) are eligible for \"Certificates of Attendance,\" and accreditation, provided that accreditation requirements are met. For groups larger than 20 or for additional logins for other locations, please call +1 781.972.5400 or toll-free in the U.S. 800.856.2556, or email customer.service@barnettinternational.com for pricing.\u003c\/p\u003e\u003cp class=\"header-block-grey\"\u003eAccreditation Information\u003c\/p\u003e\u003cp\u003eBarnett International is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. Participants will receive 1.5 hours (0.15 CEUs) of continuing education credit for full participation, including the completion of a pre-test, post-test, and program evaluation. Barnett International will issue a receipt of completion for earned CEUs within three weeks of program completion. ACPE#: 0778-0000-25-043-L99-P. Released: 10\/25. \u003c\/p\u003e\u003cp align=\"center\"\u003e\u003cspan class=\"bold\"\u003eHold this course at your company! For more information, contact Naila Ganatra at +1 215.413.2471.\u003c\/span\u003e \u003c\/p\u003e","brand":"Barnett International","offers":[{"title":"Commercial","offer_id":53474476130669,"sku":"BI17555","price":735.0,"currency_code":"USD","in_stock":true}]},{"product_id":"ich-gcp-e6-r3-updates-impact-on-clinical-data-management-2026-11-18","title":"ICH GCP E6 (R3) Updates: Impact on Clinical Data Management","description":"\u003cp class=\"header-block-grey\"\u003eCourse Description\u003c\/p\u003e\u003cp\u003eClinical Data Management (CDM) plays a pivotal role in the success of clinical trials, ensuring data accuracy, integrity, and compliance with regulatory requirements. The ICH GCP E6(R3) update refines the approach to CDM by incorporating a risk-based framework for managing data and enhancing oversight mechanisms. This web seminar will explore the updated guidelines, focusing on the evolving requirements for electronic systems, data integrity, and the integration of quality management principles throughout the trial lifecycle. Participants will gain insights into the role of risk management in clinical data collection and analysis, now positioned as a standard practice rather than an optional strategy. The session will also cover best practices, industry standards, and practical approaches to achieving compliance with the revised guidelines. Additionally, the seminar will highlight the implications of the R3 updates and how they reshape CDM processes, ensuring data quality and regulatory adherence.\u003c\/p\u003e\u003cp class=\"header-block-grey\"\u003eLearning Objectives\u003c\/p\u003e\u003cul type=\"disc\"\u003e \u003cli\u003eDefine the recommended SOPs for electronic systems used to collect and manage clinical trial data under ICH GCP E6(R3)\u003c\/li\u003e \u003cli\u003eDiscuss data integrity considerations and their critical role in clinical trials, as outlined in the revised guidelines\u003c\/li\u003e \u003cli\u003eIdentify risk management principles in clinical trial conduct and theirdirect connection to Clinical Data Management practices\u003c\/li\u003e \u003cli\u003eReview quality management principles and tools to implement a risk-based quality approach in clinical trials\u003c\/li\u003e \u003c\/ul\u003e\u003cp class=\"header-block-grey\"\u003eWho Should Attend\u003c\/p\u003e\u003cul type=\"disc\"\u003e \u003cli\u003eClinical Data Managers\u003c\/li\u003e \u003cli\u003eClinical Data Scientists\u003c\/li\u003e \u003cli\u003eClinical Quality Assurance Professionals\u003c\/li\u003e \u003cli\u003eClinical Compliance Personnel\u003c\/li\u003e \u003c\/ul\u003e\u003cp class=\"header-block-grey\"\u003eInstructor\u003c\/p\u003e\u003cp\u003eDenise G. Redkar-Brown, MT\u003c\/p\u003e\u003cp\u003e\u003cspan class=\"purple-link\"\u003e\u003ca href=\"https:\/\/stage.barnettinternational.com\/instructor-biographies\" title=\"Click here for complete trainer biographies\"\u003eClick here for complete trainer biographies\u003c\/a\u003e\u003c\/span\u003e\u003c\/p\u003e\u003cp class=\"header-block-grey\"\u003eRegistration Fees\u003c\/p\u003e\u003cp\u003e$735*\u003c\/p\u003e\u003cp\u003e*Includes up to 20 participants per login at a single location. All participants (up to 20) are eligible for \"Certificates of Attendance,\" and accreditation, provided that accreditation requirements are met. For groups larger than 20 or for additional logins for other locations, please call +1 781.972.5400 or toll-free in the U.S. 800.856.2556, or email customer.service@barnettinternational.com for pricing.\u003c\/p\u003e\u003cp class=\"header-block-grey\"\u003eAccreditation Information\u003c\/p\u003e\u003cp\u003eBarnett International is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. Participants will receive 1.5 hours (0.15 CEUs) of continuing education credit for full participation, including the completion of a pre-test, post-test, and program evaluation. Barnett International will issue a receipt of completion for earned CEUs within three weeks of program completion. ACPE#: 0778-0000-25-032-L99-P. Released: 4\/25. \u003c\/p\u003e\u003cp align=\"center\"\u003e\u003cspan class=\"bold\"\u003eHold this course at your company! For more information, contact Naila Ganatra at +1 215.413.2471. \u003c\/span\u003e\u003c\/p\u003e","brand":"Barnett International","offers":[{"title":"Commercial","offer_id":53474477015405,"sku":"BI17539","price":735.0,"currency_code":"USD","in_stock":true}]},{"product_id":"gcp-renovation-ich-e8-r1-and-ich-e6-r3-2026-11-13","title":"GCP Renovation (ICH E8(R1) and ICH E6 (R3))","description":"\u003cp class=\"header-block-grey\"\u003eCourse Description\u003c\/p\u003e\u003cp\u003eIn January 2017, the ICH GCP renovation was initiated, ushering in a new era of regulatory guidelines. The finalization of ICH E8(R1) in 2021 has brought forth a clear roadmap for integrating Quality by Design principles into the design and development of clinical trials. Simultaneously, ICH GCP (ICH E6(R3)) includes a complete rewrite of existing the guideline, triggering a paradigm shift in how companies approach these changes. While the majority of these changes are anticipated to be embraced by the industry as a means to modernize the regulatory landscape, some formidable challenges will need to be addressed. In this web seminar, we will delve into the subject matter in alignment with the intentions of the International Council for Harmonisation (ICH). We will explore how ICH E6 and E8 complement each other and discuss their implications for the industry's evolving regulatory environment.\u003c\/p\u003e\u003cp class=\"header-block-grey\"\u003eLearning Objectives\u003c\/p\u003e\u003cul type=\"disc\"\u003e \u003cli\u003eDescribe the regulatory background that has led to the changes\u003c\/li\u003e \u003cli\u003eExplain the changes within ICH E8(R1)\u003c\/li\u003e \u003cli\u003eExplain the changes within ICH E6(R3)\u003c\/li\u003e \u003cli\u003eDescribe the concept of Quality by Design and its application to clinical development\u003c\/li\u003e \u003cli\u003eUnderstand the role of risk management and measured quality in Quality by Design\u003c\/li\u003e \u003c\/ul\u003e\u003cp class=\"header-block-grey\"\u003eWho Should Attend\u003c\/p\u003e\u003cul type=\"disc\"\u003e \u003cli\u003eClinical Research Associates\/Monitors\u003c\/li\u003e \u003cli\u003eClinical Trial Leads\u003c\/li\u003e \u003cli\u003eData Managers\/Data Scientists\u003c\/li\u003e \u003cli\u003eStatisticians\u003c\/li\u003e \u003cli\u003eRegulatory Affairs Professionals\u003c\/li\u003e \u003cli\u003ePharmacovigilance Professionals\u003c\/li\u003e \u003cli\u003eExecutive Management\u003c\/li\u003e \u003c\/ul\u003e\u003cp class=\"header-block-grey\"\u003eInstructor\u003c\/p\u003e\u003cp\u003eAndy Lawton\u003c\/p\u003e\u003cp\u003e\u003ca href=\"https:\/\/www.barnettinternational.com\/instructor-biographies\" title=\"Click here for complete trainer biographies\" style=\"font-family:inherit;font-size:inherit;text-align:inherit;text-transform:inherit;white-space:inherit;word-spacing:normal;\"\u003eClick here for complete trainer biographies\u003c\/a\u003e\u003c\/p\u003e\u003cp class=\"header-block-grey\"\u003eRegistration Fees\u003c\/p\u003e\u003cp\u003e$835*\u003c\/p\u003e\u003cp\u003e*Includes up to 20 participants per login at a single location. All participants (up to 20) are eligible for \"Certificates of Attendance,\" and accreditation, provided that accreditation requirements are met. For groups larger than 20 or for additional logins for other locations, please call +1 781.972.5400 or toll-free in the U.S. 800.856.2556, or email customer.service@barnettinternational.com for pricing.\u003c\/p\u003e\u003cp class=\"header-block-grey\"\u003eAccreditation Information\u003c\/p\u003e\u003cp\u003eBarnett International is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. Participants will receive 2.5 hours (0.25 CEUs) of continuing education credit for full participation, including the completion of a pre-test, post-test, and program evaluation. Barnett International will issue a receipt of completion for earned CEUs within three weeks of program completion. ACPE#: 0778-0000-25-036-L99-P. Released: 2\/25. \u003c\/p\u003e\u003cp align=\"center\"\u003e\u003cspan class=\"bold\"\u003eHold this course at your company! For more information, contact Naila Ganatra at +1 215.413.2471. \u003c\/span\u003e\u003c\/p\u003e","brand":"Barnett International","offers":[{"title":"Commercial","offer_id":53474475082093,"sku":"BI17530","price":835.0,"currency_code":"USD","in_stock":true}]},{"product_id":"10-week-risk-management-risk-based-quality-management-for-clinical-trials-certification-program-2026-10-24","title":"10-Week Risk Management\/Risk-Based Quality Management for Clinical Trials Certification Program","description":"\u003cp class=\"header-block-grey\"\u003eCourse Description\u003c\/p\u003e\n\u003cdiv\u003e\n\u003cp\u003eAre you prepared for Quality Risk Management (QRM), Risk Management (RM), Risk-Based Quality Management (RBQM)? The finalization of ICH GCP E6(R3) in January 2025 revealed that the guideline still requires risk-based approaches to managing quality in clinical trials. This 10-Week series takes you through, step-by-step, how to execute these requirements. We will focus on the critical elements for clinical trial sponsors and CROs included in the ICH GCP E6(R3) expectations, while highlighting key points from other regulatory bodies such as ISO 31000 Risk Management. Each step of risk identification, assessment, control, review, reporting, management, and communication are also reviewed along with what is to be documented in the clinical study report.\u003c\/p\u003e\n\u003cp\u003ePrior to the start of the course, participants will receive their login credentials and links to access and download the many class resources and class meeting links. Upon course completion, participants will be provided training certificates. In order to receive accreditation CEUs, participants are required to pass both a mid-term and final exam. Upon completion of the exams, CEU certificates will be provided.\u003c\/p\u003e\n\u003cp class=\"header-block-grey\"\u003eLearning Objectives\u003c\/p\u003e\n\u003cul type=\"disc\"\u003e\n\u003cli\u003eDescribe the expectations of QRM in relation to the ICH E6(R3) updates\u003c\/li\u003e\n\u003cli\u003eDiscuss how to analyze risks and develop a risk register\u003c\/li\u003e\n\u003cli\u003eDescribe how to use multiple risk analysis tools including: Failure Mode Effect Analysis (FMEA), Bow Tie, and Affinity Diagram\u003c\/li\u003e\n\u003cli\u003eDescribe how to formulate risk mitigation strategies\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003cp class=\"header-block-grey\"\u003eCourse Outline\u003c\/p\u003e\n\u003cul type=\"disc\"\u003e\n\u003cli\u003eModule 1: Quality Risk Management: Quality Risk Management\/Risk Management (ICH GCP E6(R3) and ISO 31000), Risk Management Policy\/ Program, Accountability and Resources\u003c\/li\u003e\n\u003cli\u003eModule 2: Risk Management Plan and Culture: Framework for Communicating Risk Within an Organization\/Program, Strategies and Challenges for Risk Stakeholders, Required Commitment and Mandate\u003c\/li\u003e\n\u003cli\u003eModule 3: Risk Identification: Risk Identification and When to Start, Protocol Risks, Risk Register (Risk Log) for Tracking Risks\u003c\/li\u003e\n\u003cli\u003eModule 4: Risk Evaluation: Impact of Error, Detection of the Error, Risk Priority Number (RPN) Values\u003c\/li\u003e\n\u003cli\u003eModule 5: Risk Analysis Tools Part I: FMEA, Bow Tie, and Delphi technique\u003c\/li\u003e\n\u003cli\u003eModule 6: Risk Analysis Tools Part II: SWOT (Strengths, Weakness, Opportunities, Threats), Affinity Diagram, Cause and Effect Analysis\u003c\/li\u003e\n\u003cli\u003eModule 7: Risk Control: Risk Mitigation Strategies, Risk Mitigation Options, Priority Rankings of Risk Mitigation Plans\u003c\/li\u003e\n\u003cli\u003eModule 8: Risk Communication: Risk Mitigation Plans in the Risk Register\/Log, Impact of Internal and External Stakeholders, Escalation Processes and Plans\u003c\/li\u003e\n\u003cli\u003eModule 9: Risk Review: Periodic Review, Risk Assessment, and Risk Detection\u003c\/li\u003e\n\u003cli\u003eModule 10: Risk Reporting: Risks, Deviations, Predefined Quality Tolerance Limits, Lessons Learned\/Continuous Learning, Required Documentation in the Clinical Study Report\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003cp class=\"header-block-grey\"\u003eWho Should Attend\u003c\/p\u003e\n\u003cul type=\"disc\"\u003e\n\u003cli\u003eQuality Control\/Assurance Professionals\u003c\/li\u003e\n\u003cli\u003eRegulatory Affairs Professionals\u003c\/li\u003e\n\u003cli\u003eClinical Research\/Operations Personnel\u003c\/li\u003e\n\u003cli\u003eInformation Technology\/Security Personnel\u003c\/li\u003e\n\u003cli\u003eData Managers\u003c\/li\u003e\n\u003cli\u003eStudy Managers\u003c\/li\u003e\n\u003cli\u003eProject Physicians\/Medical Monitors\u003c\/li\u003e\n\u003cli\u003ePharmacovigilance Professionals\u003c\/li\u003e\n\u003cli\u003eBiostatisticians\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003cp\u003eNOTE: This course is for individual registrants only and does not allow for group training.\u003c\/p\u003e\n\u003cp class=\"abstract\"\u003e\u003cspan class=\"bold\"\u003eWhat previous students have said ...\u003c\/span\u003e\u003c\/p\u003e\n\u003cp\u003e\"This course is beyond my expectation with very practical examples and tools. Both instructors are excellent with great attention to address participants' questions.\"\u003c\/p\u003e\n\u003cp\u003e\"The course was well designed. These lessons were valuable in seeing the big picture of clinical research.\"\u003c\/p\u003e\n\u003cp\u003e\"The tools provided were great. I hope to use the risk log and risk analysis tools.\"\u003c\/p\u003e\n\u003cp class=\"header-block-grey\"\u003eInstructor\u003c\/p\u003e\n\u003cp class=\"bold-italic\"\u003e\u003cb\u003e\u003ci\u003eThe course will be led by one of the following instructors:\u003c\/i\u003e\u003c\/b\u003e\u003c\/p\u003e\n\u003cp\u003eSusan M. Leister, M.B.A., Ph.D., CQA, CSSBB\u003c\/p\u003e\n\u003cp\u003eShelia Russell McCullers, M.S., D.M.\u003c\/p\u003e\n\u003cp\u003e\u003cspan class=\"purple-link\"\u003e\u003ca href=\"https:\/\/stage.barnettinternational.com\/instructor-biographies\" title=\"Click here for complete trainer biographies\"\u003eClick here for complete trainer biographies\u003c\/a\u003e\u003c\/span\u003e\u003c\/p\u003e\n\u003cp class=\"header-block-grey\"\u003e\u003cspan class=\"purple-link\"\u003e\u003cb\u003e\u003ci\u003eCourse Length and Time\u003c\/i\u003e\u003c\/b\u003e\u003c\/span\u003e\u003c\/p\u003e\n\u003cp\u003e10 weeks for 2 hours each week.\u003c\/p\u003e\n\u003cp class=\"header-block-grey\"\u003eRegistration Fees\u003c\/p\u003e\n\u003cp\u003e$1,695 by Early Bird Deadline\u003c\/p\u003e\n\u003cp\u003e$1,895 after Early Bird Deadline\u003c\/p\u003e\n\u003cp\u003eThis course is for individual registrants only and does not allow for group training.\u003c\/p\u003e\n\u003cp\u003eAll participants are eligible for \"Certificates of Attendance,\" and accreditation, provided that accreditation requirements are met.\u003c\/p\u003e\n\u003cp class=\"header-block-grey\"\u003eAccreditation Information\u003c\/p\u003e\n\u003cp\u003eBarnett International is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. Participants will receive 20 hours (2.0 CEUs) of continuing education credit for full participation, including the completion of a mid-term exam, final exam, and program evaluation. Barnett International will issue a receipt of completion for earned CEUs within three weeks of program completion. \u003cmeta charset=\"utf-8\"\u003eACPE#: \u003cmeta charset=\"utf-8\"\u003e\u003cspan\u003e0778-0000-26-003-L99-P.\u003c\/span\u003e Released: 5\/26.\u003c\/p\u003e\n\u003cp align=\"center\"\u003e\u003cspan class=\"bold\"\u003eHold this course at your company! For more information, contact Naila Ganatra at +1 215.413.2471.\u003c\/span\u003e\u003c\/p\u003e\n\u003c\/div\u003e","brand":"Barnett International","offers":[{"title":"Commercial","offer_id":53474452046189,"sku":"BI17493","price":1895.0,"currency_code":"USD","in_stock":true}]}],"url":"https:\/\/www.barnettinternational.com\/collections\/r3-training.oembed","provider":"Barnett International ","version":"1.0","type":"link"}