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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.
- 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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