Recommended Standards of Education and Training
Description: 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
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slide1. 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<br>
slide2. 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<br>
slide3. 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<br>
slide4. Chapter 1: Background and Problem Statement Original Version. September 2022<br>
slide5. Introduction and Chapter 1: Background and Problem Statement Revisions January 30, 2023<br>
slide6. Chapter 1: Background and Problem Statement Revisions to Chapter One/Cont’n January 2023<br>
slide7. Further issues to consider in the proposed narrative Is what has been written so far appropriate?Â
Does it address the needs of the sections of Chapter 1?
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?
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?
Style of writing (for CIOMS reports):
clarity of writing for non-scientific/lay audiences
relative length / granularity of the sectional topics and
need to expand or shorten some/all of them.
Need to complete the reference section<br>
slide8. 8 Thanks for your attention Honorio.silva@ifappacademy.org<br>
Honorio Silva, MD
On behalf of the Writing Team
Fourth Meeting of the CIOMS Working Group
Via Zoom, January 30th, 2023<br>
slide2. 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<br>
slide3. 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<br>
slide4. Chapter 1: Background and Problem Statement Original Version. September 2022<br>
slide5. Introduction and Chapter 1: Background and Problem Statement Revisions January 30, 2023<br>
slide6. Chapter 1: Background and Problem Statement Revisions to Chapter One/Cont’n January 2023<br>
slide7. Further issues to consider in the proposed narrative Is what has been written so far appropriate?Â
Does it address the needs of the sections of Chapter 1?
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?
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?
Style of writing (for CIOMS reports):
clarity of writing for non-scientific/lay audiences
relative length / granularity of the sectional topics and
need to expand or shorten some/all of them.
Need to complete the reference section<br>
slide8. 8 Thanks for your attention Honorio.silva@ifappacademy.org<br>