AS Write Sebastian Kristof's medical writing website

Experience and Background

Experience

  • Regulatory medical writing experience (2 years)
    Includes writing and editing clinical study protocols and amendments, clinical study reports (CSR), investigator brochures (IB), Investigational New Drug Applications (IND, CFR Part 312), New Drug Applications (NDA, CFR Part 314), adverse event (AE) and serious adverse event (SAE) reports, training manuals, product monographs, package inserts, patient information, professional communications, medical manuscripts, grant proposals, literature reviews
  • Postdoctoral program in bioinformatics at the University of California (San Diego), department of Cellular and Molecular Medicine (2 years)
  • Clinical research consulting at National Academy of Postgraduate Education, Kyiv, Ukraine (2 years)
  • Psychiatry/psychotherapy experience (4 years)

Education

  • Yale University, Yale Center for Medical Informatics; New Haven, CT
    Postdoctoral fellowship, Medical Informatics (funded by National Library of Medicine) 2010
  • National Medical University; Kyiv, Ukraine
    Doctor of Medicine (MD)  1999
    Psychiatry residency  2000

Continuing Education and Certificates

  • Good Clinical Practices (GCP), National Institutes of Health (NIH); Bethesda, MD  2016
  • Clinical Research Training, National Institutes of Health (NIH); Bethesda, MD  2015
  • ECFMG Certificate, Educational Commission for Foreign Medical Graduates, USA.
    Awarded after verifying international MD equivalency and passing United States Medical Licensing Examination (USMLE) Step 1 and Step 2 Clinical Knowledge (CK) and Clinical Skills (CS)  2007
  • AMWA webinars  2015
  • Business Analysis, CTE Solutions, Ottawa, ON, Canada  2015

Publications

  • Kristof S (published as Konovalov S), Garcia-Bassets I. Analysis of the levels of lysine-specific demethylase 1 (LSD1) mRNA in human ovarian tumors and the effects of chemical LSD1 inhibitors in ovarian cancer cell lines. Journal of Ovarian Research. 2013;6(1):75.
  • Benner C, Kristof S (published as Konovalov S), Mackintosh C, Hutt K, Stunnenberg R, Garcia-Bassets I. Decoding a Signature-Based Model of Transcription Cofactor Recruitment Dictated by Cardinal Cis-Regulatory Elements in Proximal Promoter Regions. PLoS Genetics. 2013;9(11):e1003906.
  • Kristof S (published as Konovalov S), Scotch M, Post L, Brandt C. Biomedical Informatics Techniques for Processing and Analyzing Web Blogs of Military Service Members. J Med Internet Res. 2010;12(4):e45.
  • Kristof S (published as Konovalov S), Muralee S, Tampi R. Anticonvulsants for the treatment of behavioral and psychological symptoms of dementia: a literature review. IPG. 2007;20(02).

Full publications as a PDF file are available on request.