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Dr Iain
Colquhoun
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Iain has been writing for MEDECO
since 1996:
he is Medical writer who is a member of the European Medical
Writers Association (EMWA) and the Organisation for
Professionals in Clinical Research (TOPRA), who has maintained currency of
knowledge through on-going EMWA accredited training courses, and
who has written –
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55+ clinical and non-clinical CTD modules for drugs with
a well-established use |
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systematic literature reviews for a variety of therapies
and therapeutic areas |
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clinical literature reviews for medical devices |
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clinical study reports for Phase I, II and III studies
to ICH standards |
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assessments of therapies for switching from POM to P and
P to GSL |
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manuscripts for submission to leading medical journals
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clinical expert reports to EU standards. |
His wide-ranging background
has provided experience in writing scientific, project and
situation reports for individuals, companies, governments and
agencies. He has gained particular expertise in the
bibliographic reviews for CTDs and clinical evaluations
for medical devices, changes of labeling
and switching from prescription to pharmacy or GSL. |
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Dr Helen
Colquhoun
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A
pharmaceutical physician since 1988 and an independent
consultant to pharmaceutical and bio-technology companies since 1995: graduated 1979 BSc (Hons) Biological Sciences and
Genetics, 1984 MBChB and 1991 Diploma in Pharmaceutical Medicine (RCP). A member of the Royal College of General
Practitioners and a Fellow of the Faculty of Pharmaceutical Physicians
(accredited 2005). Experience includes: the design, planning and
management of product development programmes; the design and set up of clinical pharmacology Phase I, Phase II, Phase III and
Phase IV studies in the UK, Europe, North America and
Australia; writing of protocols, PSURs, study reports, expert
reports and other regulatory documentation; the provision of
medical assessment of on-market and clinical trial adverse
events; interactions with regulatory authorities including the
FDA, EMEA, TGA and European national agencies.
Helen is CEO
of a CRO specialising in Medical Devices. |
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