23 Chapter 3: General Considerations for Quality Regulatory Writing
Introduction
Regulatory writing combines language, science
or engineering, medicine, and law to create com-
munications that advance medical, scientific, and
manufacturing objectives. In biopharmaceutical,
vaccine, and device development, the principal goal
of regulatory writing is to produce documents for
submission to health authorities that are scientif-
ically and editorially accurate, reflect regulatory
strategy and corporate goals, are compliant with
applicable regulations and guidelines, and are clearly
worded concerning key messages.
It is essential to keep the prospective reader in
mind at all times, especially in terms of choice of
wording and depth of detail.
Regulatory documents often have multiple
authors across several subject matter areas this reality
complicates the ability to write with a consistent
voice. Well-designed documents provide information
the audience can understand and interpret easily.
For regulatory deliverables, authors, reviewers,
and editors should consider:
• Does the document present one clear,
consistent representation or narrative of the
data?
• Are the safety information and risks
disclosed and discussed adequately? Is
adequate information included to support
safety conclusions?
• Is all information and terminology
consistent?
• Are previous discussions with the health
authority addressed and consistent with all
prior meeting minutes?
Teamwork for Success
Expectations and team roles should be clarified early,
and the importance of the editorial and writing jobs
should be made clear to the team. Rapport-building
and communication are critical to promote this
understanding. One editorial team member and one
content expert team member could be responsible
for assessing and presenting key messages and con-
clusions within documents.
Barriers to Effective Communication
Effective regulatory communication requires the
clear and accurate communication of key medical,
scientific, and quality messages while also explaining
complex data. Recipients of regulatory documents
include health authority reviewers (FDA, EMA,
European notified bodies, etc.), physician investiga-
tors, study coordinators, Institutional Review Board
(IRB) members, pharmacists, and insurance provid-
ers). These groups have different needs as readers.
Poor communication can have real and costly
consequences:1
3
General Considerations for Quality
Regulatory Writing
By E. Mitchell Seymour, PhD, RAC and Gert Bos, MSc, PhD, FRAPS
Introduction
Regulatory writing combines language, science
or engineering, medicine, and law to create com-
munications that advance medical, scientific, and
manufacturing objectives. In biopharmaceutical,
vaccine, and device development, the principal goal
of regulatory writing is to produce documents for
submission to health authorities that are scientif-
ically and editorially accurate, reflect regulatory
strategy and corporate goals, are compliant with
applicable regulations and guidelines, and are clearly
worded concerning key messages.
It is essential to keep the prospective reader in
mind at all times, especially in terms of choice of
wording and depth of detail.
Regulatory documents often have multiple
authors across several subject matter areas this reality
complicates the ability to write with a consistent
voice. Well-designed documents provide information
the audience can understand and interpret easily.
For regulatory deliverables, authors, reviewers,
and editors should consider:
• Does the document present one clear,
consistent representation or narrative of the
data?
• Are the safety information and risks
disclosed and discussed adequately? Is
adequate information included to support
safety conclusions?
• Is all information and terminology
consistent?
• Are previous discussions with the health
authority addressed and consistent with all
prior meeting minutes?
Teamwork for Success
Expectations and team roles should be clarified early,
and the importance of the editorial and writing jobs
should be made clear to the team. Rapport-building
and communication are critical to promote this
understanding. One editorial team member and one
content expert team member could be responsible
for assessing and presenting key messages and con-
clusions within documents.
Barriers to Effective Communication
Effective regulatory communication requires the
clear and accurate communication of key medical,
scientific, and quality messages while also explaining
complex data. Recipients of regulatory documents
include health authority reviewers (FDA, EMA,
European notified bodies, etc.), physician investiga-
tors, study coordinators, Institutional Review Board
(IRB) members, pharmacists, and insurance provid-
ers). These groups have different needs as readers.
Poor communication can have real and costly
consequences:1
3
General Considerations for Quality
Regulatory Writing
By E. Mitchell Seymour, PhD, RAC and Gert Bos, MSc, PhD, FRAPS