生物技术虚拟图书馆:临床试验及法律事务
Information on Clinical Trials
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.
- 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
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