CIOMS WG Education Virtual Meeting - Chapter 1 Overview
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Introduction and Chapter 1
Introduction 1/2
•
Very long (7 pages)
•
Contains a large part that will be moved to Chapter 1
•
Essential content to be maintained:
The recent rapid pace of change in science has produced new
medicines that have been developed and approved extremely rapidly,
thereby rendering appreciation of the benefits and risks, as well as the
regulatory assessment of these medicines challenging for both
healthcare professionals and patients.
Challenges for HCPs involved in medicines development.
Why it is important to increase education
Overview of CIOMS activities, including Working Group XI
2
Introduction 2/2
Last paragraph page 10 and first paragraphs of page 11 – phases of
development
Succinct descriptions of stakeholders and their needs (Table 1 to be moved to
next Chapter)
Purpose of the Report – to be extensively reworded
•
To be clarified/discussed:
Last paragraph of page 13
Overview of CIOMS activities, including Working Group XI
3
Chapter 1
•
Essential content to be maintained
:
Medicinal products lifecycle
Current trends in R&D
Different educational needs – to be aligned with the stakeholders identified, and cut
on page 22, where it re-starts with CT-specific training needs
•
To be moved elsewhere and/or reworded:
Challenges and opportunities (too focused on CT operational needs)
Section 5
(nearly all focused on competencies), should be a separate Chapter or
integrated in other sections of the report.
To be done
- Integration of all the comments received and
alignment with following Chapters
Overview of CIOMS activities, including Working Group XI
4
This material discusses the challenges and advancements in the rapid development of new medicines, emphasizing the importance of education for healthcare professionals. It provides insights into the medicinal products lifecycle, current trends in research and development, and aligning educational needs with stakeholders. Suggestions for restructuring and rewording specific sections are also outlined.
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Presentation Transcript
CIOMS WG Education Virtual Meeting 26 October 2023 Introduction and Chapter 1 Enrica Alteri MD
Introduction 1/2 Very long (7 pages) Contains a large part that will be moved to Chapter 1 Essential content to be maintained: The recent rapid pace of change in science has produced new medicines that have been developed and approved extremely rapidly, thereby rendering appreciation of the benefits and risks, as well as the regulatory assessment of these medicines challenging for both healthcare professionals and patients. Challenges for HCPs involved in medicines development. Why it is important to increase education Overview of CIOMS activities, including Working Group XI 2
Introduction 2/2 Last paragraph page 10 and first paragraphs of page 11 phases of development Succinct descriptions of stakeholders and their needs (Table 1 to be moved to next Chapter) Purpose of the Report to be extensively reworded To be clarified/discussed: Last paragraph of page 13 Overview of CIOMS activities, including Working Group XI 3
Chapter 1 Essential content to be maintained: Medicinal products lifecycle Current trends in R&D Different educational needs to be aligned with the stakeholders identified, and cut on page 22, where it re-starts with CT-specific training needs To be moved elsewhere and/or reworded: Challenges and opportunities (too focused on CT operational needs) Section 5 (nearly all focused on competencies), should be a separate Chapter or integrated in other sections of the report. To be done - Integration of all the comments received and alignment with following Chapters Overview of CIOMS activities, including Working Group XI 4
