Dr Iain Colquhoun  | 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 –  | 65+ clinical and non-clinical CTD modules for drugs with a well-established use | | systematic literature reviews for a variety of therapies and therapeutic areas | | clinical literature reviews for medical devices | | clinical study reports for Phase I, II and III studies to ICH standards | | assessments of therapies for switching from POM to P and P to GSL | | manuscripts for submission to leading medical journals | | 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. |
| Dr Helen Colquhoun  | 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 with CCST (UK Specialist Accreditation) in Pharmaceutical Medicine in 2006. 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, EMA, BfArM, AFFSAPS and TGA. Helen is CEO of a CRO specialising in Medical Devices. | | |
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