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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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Dr.rer.nat. Elke Schlüssel |
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Life Sciences Research
Birkenleiten 10
81543 München
Germany
Email: elke.schluessel@t-online.de
Web: www.life-sciences-research.eu
Title: Dr.rer.nat.
First Name: Elke
Last Name: Schlüssel
Phone:
Fax: +49(0) 89 62 48 97 53
Mobile: +49(0) 179 902 88 65
Skills And Services Offered:
I have a humanistic background, hold a life sciences degree and an EMWA certificate (subject area: drug development).During more than 13 years in basic and in clinical research I gathered experience as research scientist, clinical research associate/monitor, leader of a regulatory services group and regulatory consultant, translator, medical writer, and quality assurance manager/auditor.
I prepare, edit and proofread all documents related to the conduct and description of clinical studies a/t applying requirements, e.g. - protocols, observational plans,
- patient information leaflets, informed consent forms,
- clinical trial applications (authorities, Ethics Committees),
- integrated clinical study reports, reports on post-marketing surveillance studies.
I also offer- translations of all kinds of documents English <-> German,
- preparation of publications, presentations
- critical evaluation of medical/scientific literature
- evaluation of QM systems and preparation of SOPs
Expertise:
I have a background of biology (Dipl.-Biol. Univ., Technical University Munich), biochemistry, environmental research, food technology (Fraunhofer Institutes), phytopathology and animal experimentation.On the clinical side, I am especially experienced in - diabetes, homocysteinaemia,
- rheumatoide arthritis, osteoarthritis,
- atherosclerosis, coronary heart disease, venous insufficiency,
- asthma,
- psoriasis,
- photoimmune therapy,
- cataract,
- migraine, pain management,
- antibiotics,
- transdermal delivery of macromolecular drugs.
New subject areas are always highly welcome.
Other Information:
I have an excellent knowledge of the legal environment of drug development, a good understanding of the needs of small biotech start-ups as well as of large pharma companies. I also know what services are expected to be delivered by contract research organisations to their clients. I work independently on a home-office basis or as integral part of a team at my clients' premises. I am a member of EMWA and DGPharMed (German Association for Pharmaceutical Medicine) and regularly attend courses to refresh and expand my professional skills. I am actively involved in animal protection and nature conservation projects.
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