Medical Writing, Volume 23, Issue 4 (2014)

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Medical Writing, Volume 23, Issue 4 (2014)

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Vol 24, 2015 Volume 23, 2014 Vol 22, 2013 Vol 21, 2012
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Post-Approval Regulatory Writing

Editorial

Editorial
Post-approval regulatory writing
Lisa Chamberlain-James
Page: 257
Published online: 06 Nov 2014
CitationforPost-approval regulatory writing | Full Text | PDF (47.3 KB)
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Free Access

President's Message

Article
President's Message
Julia Donnelly
Page: 258
Published online: 06 Nov 2014
CitationforPresident's Message | Full Text | PDF (52.5 KB)
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Articles on post-approval regulatory writing

Article
Responding to concerns over the PSMF: Inspectors offer key insights
Dakshayini Kulkarni
Pages: 259-261
Published online: 06 Nov 2014
AbstractforResponding to concerns over the PSMF: Inspectors offer key insights | Full Text | References | PDF (62.3 KB)
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Article
Post-approval regulatory writing – How different is it from writing pre-approval documents?
Sunil Modali
Pages: 262-266
Published online: 06 Nov 2014
AbstractforPost-approval regulatory writing – How different is it from writing pre-approval documents? | Full Text | References | PDF (99.9 KB)
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Article
Strategic medical writing in the post-authorisation phase
Sarah J. Richardson
Pages: 267-272
Published online: 06 Nov 2014
AbstractforStrategic medical writing in the post-authorisation phase | Full Text | References | PDF (133.9 KB)
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Article
Non-interventional Post-Authorisation Safety Studies (NI-PASS): A different type of report
Greg Morley
Pages: 273-276
Published online: 06 Nov 2014
AbstractforNon-interventional Post-Authorisation Safety Studies (NI-PASS): A different type of report | Full Text | References | PDF (77.2 KB)
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Article
Writing publications for advisory boards
Amy Whereat
Pages: 277-279
Published online: 06 Nov 2014
AbstractforWriting publications for advisory boards | Full Text | PDF (70.3 KB)
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Other articles

Article
The EMWA Budapest Working Group: A 2-year collaboration to make recommendations for aligning the ICH E3 guideline with current practice and developing clinical study protocol guidance
Sam Hamilton, Walther Seiler & Art Gertel
Pages: 281-288
Published online: 06 Nov 2014
AbstractforThe EMWA Budapest Working Group: A 2-year collaboration to make recommendations for aligning the ICH E3 guideline with current practice and developing clinical study protocol guidance | Full Text | References | PDF (223.2 KB)
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Open Access
Article
Profile: An interview with Esther Moreno Barriuso: On some fundamental concerns of medical interpreting
Laura Carolina Collada Ali
Pages: 289-290
Published online: 06 Nov 2014
CitationforProfile: An interview with Esther Moreno Barriuso: On some fundamental concerns of medical interpreting | Full Text | PDF (54 KB)
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Regular features

Article
News from the EMA
Monika Benstetter & Martin Harvey
Pages: 293-297
Published online: 06 Nov 2014
First Page PreviewforNews from the EMA | Full Text | PDF (76.3 KB)
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Article
The Webscout
Karin Eichele
Page: 299
Published online: 06 Nov 2014
CitationforThe Webscout | Full Text | PDF (63.9 KB)
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Book Review
In the Bookstores
Alison McIntosh
Pages: 301-302
Published online: 06 Nov 2014
CitationforIn the Bookstores | Full Text | References | PDF (63.3 KB)
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Out on Our Own

Article
Out on Our Own
Kathryn White, Alistair Reeves, Janet R. Davies, Susanne Geercken, Matt Craven, Michelle Storm Lane & Fiona Higgins
Pages: 303-313
Published online: 06 Nov 2014
First Page PreviewforOut on Our Own | Full Text | PDF (243.6 KB)
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The Light Stuff

Article
The Light Stuff
Barry Drees
Page: 314
Published online: 06 Nov 2014
CitationforThe Light Stuff | Full Text | PDF (48.1 KB)
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