Recommended Standards of Education and Training for Health Professionals in Medicines Development

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Overview of the revised narrative of Chapter 1 detailing the background, problem statement, and contributors of the education and training standards for health professionals participating in medicines development. The chapter outlines the stakeholders, challenges, needs, and opportunities in the medical product lifecycle and regulation, emphasizing competency-based education and systems thinking in continuing medical education.

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Recommended Standards of Education and Training for Health Professionals Participating in Medicines Development. Revised Narrative of Chapter 1: overview Honorio Silva, MD On behalf of the Writing Team Fourth Meeting of the CIOMS Working Group Via Zoom, January 30th, 2023

Chapter 1 Writing Team including new members Enrica Alteri Catherine Bates Barbara Bierer Pravin Chopra Domenico Criscuolo Tim Higenbottam Ken Kaitin Sandor Kerpel-Fronius Ingrid Klingmann Nilima Kshirsagar Lembit Rago Honorio Silva Stephen Sonstein Peter Stonier Haruko Yamamo

Chronology of Informal Process followed by the Writing WG May 31: As a result of a joint meeting including subroups 1 and 2 Individual members volunteered to write sections of the draft chapter: Contributions compiled and edited by HS and PS June 16: First Version distributed among the group members: June 23: Zoom session to discuss content and possible changes As a result, revisions and additional contributions (including references) were prepared and submitted again to HS and PS July 24: Second version was distributed among the group for review and comments Asynchronous feedback received August 31: Final Version distributed among the entire WG. September 6: entire CIOMS WG discussion in Geneva. September- January: Inputs received from several tesam members (IK, SKF, KK, NN, PC, SS, BB) January . Final Review and edits by TH, NN and H

Chapter 1: Background and Problem Statement Original Version. September 2022 Section Content Main Contributors Introduction General Overview SS/HS/All 1.1. The medical Product lifecycle and its stakeholders Short description of the lifecycle and its regulation Current Trends in Product Development Challenges and complexities HS/PS/All 1.2 Description of the problem Overall stakeholders needs Opportunities and Challenges Needs for Education HS/PS/All 1.3 Overview of different needs: Competency Based Education Systems Thinking in CME PS/HS/All HS/all Group 1: General Public and patients, advocacy groups, ethics committees and clinical trial participants Group 2: Biomedical Professionals Medical Product Developers Medical Product regulators Health professionals directly engaged in PD Physicians, Nurses and Allied Health Professionals not directly engaged in PD Other professionals (Group 3) LR/SS/NK/SK/All

Introduction and Chapter 1: Background and Problem Statement Revisions January 30, 2023 Section Content Main Contributors Introduction General Overview SS/HS/TH/KK 1. The medical Product lifecycle and its stakeholders Current Trends in Product Development Challenges and complexities; risk/benefit and value Need for competent professionals HS//TH/All 1.1. The product lifecycle and pharmaceutical regulation Short description of the lifecycle and its regulation Opportunities and Challenges HS/TH/All 2. Current trends in education in medicines and device development Applies for Medicines and Devices New technologies for assessment of risk and value Impact of COVID and needs for collaboration TH/HS/all 2.1 Description of Challenges and Opportunities Clinical Trials and needs for Education Role of stakeholders Contributions of JTF/MRCT and IFAPP Needs for collaboration TH/HS/All

Chapter 1: Background and Problem Statement Revisions to Chapter One/Cont n January 2023 Section Content Main Contributors 2.2 Overview of different needs of learners Short description of outcomes of surveys conducted by OECD, JTF/MRCT and IFAPP HS/TH/all 2.3 Changing paradigms in education for Medicinal Products Principles of adult learning Transformative learning: competency and problem-based education HS/PS/TH 2.4 Competency Based Education Definition and principles Competencies: intrinsic value and applications HS/PS/TH/all 2.5 Systems in Medical Education Basic concepts Clinical Research and Medicines Development as systems HS/TH/all 2.6 A syllabus for education and medicines development Rationale The PharmaTrain experience Needs for adaptation HS/PS/TH/all

Further issues to consider in the proposed narrative o Does it address the needs of the sections of Chapter 1? o Are the section texts written aligned completely with the section titles? Is the material of relatively correct length or too long/ short for what is expected? Is what has been written so far appropriate Is what has been written so far appropriate? Does the order of chapters need revising based on the direction that the report is (already) taking from the content of Introduction and Chapter 1? o clarity of writing for non-scientific/lay audiences o relative length / granularity of the sectional topics and o need to expand or shorten some/all of them. o Need to complete the reference section Style of writing (for CIOMS reports):