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临床试验及法律事务

    Regulatory Affairs

    • Bright & Assoc. FDA Regulatory and Quality Consultants.
    • CCH Health and Medicine FDA forms, Medicare/Medicaid forms, GAO reports, new drug and biologics approvals, etc.
    • NCRAF Regulatory Affairs Information pointers: US Gov't pointers and others of interest in Regulatory Affairs
    • RAinfo Regulatory affairs information.
    • RAPS Regulatory Affairs Professionals Organization
    • RegSource.com Comprehensive Regulatory information on Drugs/Biologics/Medical Devices and Pharmaceuticals.
    • Regulatory Affairs Forum

    Legal Services

    Other Places of Interest

    • ACRP Association of Clinical Research Professionals
    • AHCPR Agency for Health Care Policy and Research maintains a web site for clinical practice guidelines
    • ARC Affiliated Research Centers
    • Cochrane Library An electronic publication designed to supply evidence to inform people providing and receiving care, and those responsible for research, teaching, funding and administration at all levels.
    • DIA Drug Information Association
    • ERSR Center for Drug Evaluation and Research's Electronic Regulatory Submissions and Review (ERSR) web page. This page provides information about the electronic submission of regulatory information to the Center and the review of it by CDER staff. Additional guidance documents, when available in draft or final form, will be added to this page.
    • EudraNet European Union Drug Regulatory Authorities Network
    • M2 - EWG EU Multi-disciplinary Group 2 (M2) Expert Working Group (EWG) was established to facilitate international electronic communication by evaluating and recommending, open and non-proprietary - to the extent possible - Electronic Standards for the Transfer of Regulatory Information (ESTRI) that will meet the requirements of the pharmaceutical companies and regulatory authorities.
    • HUM-MOLGEN Communication Forum in Human Genetics
    • ICH International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use
    • IFPMA International Federation of Pharmaceutical Manufacturers Associations
    • International Pharmaceutical Regulatory Monitor - hardcopy - 9700 Philadelphia Court, Lanham MD 20706-4405 USA, tel: 800-345-2611 fax: 301-731-5203
    • MedDRA Global standard medical terminology.
    • NCRR/NIH Clinical Research Resources of the NCRR-supported General Clinical Research Centers and National Gene Vector Laboratories
    • NetSci Network Science ... information for those seeking advanced positions in pharmaceutical research.
    • NIH HSTAT Health Services/Technology Assessment Text
    • PhRMA Pharmaceutical Research and Manufacture of America ... excellent source of information concerning pharmaceutical development.
    • SCT Society for Clinical Trials, a professional organization.
    • SOCRA Society of Clinical Research Associates
    • UCSD Univ. of Calif. at San Diego School of Medicine Clinical Research Capabilities Directory