Regulatory affairs
نویسندگان
چکیده
منابع مشابه
Regulatory affairs issues and legal ontologies in drug development.
It usually can take more than ten years from the time a new drug is discovered, until can be launched on the market. Regulatory requirements are part of the process of drug discovery and drug development. It acts at every developmental stage. Regulatory affairs works to establish an effective and uniform balance between voluntary and regulatory compliance and agency responsiveness to consumer n...
متن کاملAcademic affairs.
• WILLARD P. GINGERICH, Ph.D., Provost and Vice President for Academic Affairs • KENNETH SUMNER, Ph.D., Acting Associate Provost for Academic Affairs • JOANNE COTE-BONANNO, Ph.D., Associate Provost for Academic Programs and Assessment • JAMES GERMAN, Ph.D., Associate Provost for Undergraduate Education • NICOLA SULLIVAN, M.B.A., Director of Administration • MARY COLON, M.A., Director, Academic ...
متن کاملDeveloping a Database for Automating regulatory Affairs in the pharmaceutical Industry
The Eprints service at the University of Westminster aims to make the research output of the University available to a wider audience. Copyright and Moral Rights remain with the authors and/or copyright owners. Users are permitted to download and/or print one copy for non-commercial private study or research. Further distribution and any use of material from within this archive for profit-makin...
متن کاملPrimary Interest Area (TRACK 9): Regulatory Affairs and Science, Quality, and GXP Compliance
Keyword: FDA Reviews, Late-Phase Clinical Trials, Women’s Participation, Sex analysis (76/100 characters) Abstract Objective: To track women’s participation in late-phase clinical trials (LPCTs) of New Molecular Entity drugs and biologics approved 2007-2009. Furthermore, to assess FDA reviews for sex-based analyses and examine labels for sex-based dosage recommendations. (248/300 characters)Obj...
متن کاملCell secretome based drug substances in regenerative medicine: when regulatory affairs meet basic science.
Department of Biomedical Imaging and Image-guided Therapy, Christian Doppler Laboratory for Cardiac and Thoracic Diagnosis and Regeneration, Department of Dermatology, Head FFG Project 852748 “APOSEC”, Department of Thoracic Surgery, Medical University Vienna, Vienna, Austria Correspondence to: Hendrik Jan Ankersmit, MD, MBA. Department of Thoracic Surgery, Medical University of Vienna, Vienna,...
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ژورنال
عنوان ژورنال: Nature Reviews Genetics
سال: 2001
ISSN: 1471-0056,1471-0064
DOI: 10.1038/35088548