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Registration is now open for the 2nd EMWA/ICR joint symposium in London on 24th February 2008. Places limited so don’t delay.
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 Gerda Roest MSc |
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Appletree Medical Writing
In den Boerenmouw 7
's-Hertogenbosch
The Netherlands
NL-5211NG
Email: g.roest@appletree.nl
Web: www.appletree.nl
First Name: Gerda
Last Name: Roest
Phone: +31(0) 73 648 0044
Fax: +31(0) 73 648 0045
Mobile:
Skills And Services Offered:
I offer a full range of Medical Writing Services for both registration and marketing purposes.
I make it a point to deliver all products cost-effectively, with constant quality and within the agreed time limits. I work in close collaboration with your clinical, regulatory or marketing experts, adhering to your SOPs and guidelines and/or to international regulations and ICH guidelines.
My services include:
Pre-submission documents:
- Clinical Study Protocols (Phase I-IV)
- Integrated Clinical Study Reports (Phase I-IV)
- Informed Consent Forms
- Investigator's Brochures
- Clinical Summaries
- Clinical Overviews
- Summaries of Product Characteristics (SPCs)
Post-submission documents:
- Product Monographs
- Scientific Brochures
- Posters, Abstracts and Manuscripts
- Patient Information Brochures
- Package Inserts / Patient Leaflets
Expertise:
I have about 20 years of experience in all stages (Phase I IV) of international pharmaceutical research & development, particularly in the areas of:
- Oncology
- Urology
- Anaesthesiology
- Haematology
- Virology
During my years as freelance medical writer (since 1997), I have gained a great deal of experience as well in the areas of:
- Pharmacokinetics
- Endocrinology
- Gastro-intestinal diseases
- Cardiovascular diseases
- Radiology
- CNS, dermatology, general health, gynaecology, orthopaedics
Other Information:
I have a doctoraal degree (Dutch MSc) in medical science from the Free University of Amsterdam; I graduated in 1987 with what could be regarded as the equivalent of a double Master's Degree in Medicine and Neuroscience.
Before I started as a freelance medical writer in 1997, my positions in the pharmaceutical industry included those of Associate Director of Clinical Research for an international biotech company and Clinical Project Leader for a major pharmaceutical company. In these companies, all and all international communications, respectively, were in English.
My years in industry made me familiar with all aspects of clinical research and development, from setting up and monitoring clinical trials to compilation of the clinical dossier for registration purposes.
I enjoy medical writing, in all its aspects.
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