相关链接-思澜医药，独立稽查，第三方稽查，GCP，qaauditor-思澜医药技术（北京）有限公司

相关链接

美国食品药品监督管理局

Archiving Submissions in Electronic Format: www.fda.gov/cder/guidance/arcguide.pdf
Bioresearch Monitoring Information System File: Clinical Investigators, CROs and IRBs from FDA 1571 & 1572s: www.fda.gov/cder/foi/special/bmis/index.htm
CDER Guidance Documents: www.fda.gov/cder/guidance/index.htm
CDER Organizational Chart: www.fda.gov/cder/cderorg.htm
CDRH Device Advice: www.fda.gov/cdrh/devadvice/
CDRH Organization Structure: www.fda.gov/cdrh/organiz.html
Clinical Investigator Disqualifications Proceedings: http://www.fda.gov/foi/clinicaldis/
Computerized Systems Used in Clinical Trials: http://www.fda.gov/ora/compliance_ref/bimo/ffinalcct.doc
Drug Approvals List: http://www.fda.gov/cder/da/da.htm
Electronic Regulatory Submissions and review: http://www.fda.gov/cder/regulatory/ersr
Expedited Safety Reporting Requirements Oct 7, 1997 Federal Register Final Rule: http://www.fda.gov/cder/regulatory/
FDA Debarred Persons List: http://www.fda.gov/ora/compliance_ref/debar/
FDA Disqualified/Restricted/Assurances List for Clinical Investigators: http://www.fda.gov/ora/compliance ref/bimo/dis res assur.htm
FDA Letters Providing Clinical Investigators with Notice of Initiation of Disqualification Proceedings and Opportunity to Explain: www.fda.gov/foi/nidpoe/default.html
FDA Modernization Act of 1997: www.fda.gov/cder/guidance/105-115.htm
CDRH Guidance: www.fda.gov/cdrh/modact/modguid.html
CDER-Related Documents: www.fda.gov/cder/fdama/
Information for Health Professionals : www.fda.gov/oc/oha
International Conference on Harmonisation: www.fda.gov/cder/guidance/guidance.htm#International Conference on Harmonisation
Investigational Human Drugs Clinical Investigator Inspection List: www.fda.gov/cder/regulatory/investigators/default.htm
Investigational Device Exemptions (IDE) Policies and Procedures: www.fda.gov/cdrh/ode.idepolcy.pdg
Laws Enforced by FDA: www.fda.gov/opacom/laws/lawtoc.htm
MedWatch: www.fda.gov/medwatch/
New Drug Approval Packages: www.fda.gov/cder/foi/nda/
Pharmacy Compounding: www.fda.gov/cder/pharmcomp/
Warning letters: www.fda.gov/foi/warning.htm
CDER Bioresearch Monitoring: www.fda.gov/cdrh/comp/bimo.html
Non-FDA Links
Clinical Trials Registry : www.clinicaltrials.gov
Office for Human Research Protections: ohrp.osophs.dhhs.gov
OHRP IRB Guidebook: ohrp.osophs.dhhs.gov/irb/irb guidebook.htm
PHS List of Investigators Subject to Administrative Action: Silk.nih.gov/public/cbzlbje.@www.orilist.html

欧洲药品管理局

DIRECTIVE 2001/83/EC, 6 November 2001: http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2001:311:0067:0128:en:PDF
DIRECTIVE 2001/20 EC, 04-April- 2001: http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2001:121:0034:0044:en:PDF
DIRECTIVE 2005/28 EC, 08-April- 2005: http://ec.europa.eu/health/files/eudralex/vol-1/dir_2005_28/dir_2005_28_en.pdf
Commission Communication (2010/C 82/01): http://ec.europa.eu/health/files/eudralex/vol-10/2010_c82_01/2010_c82_01_en.pdf
Commission Guideline Revision 1: Application Format and Documentation to be Submitted in an Application for an Ethics Committee Opinion on the Clinical Trial on Medicinal Products for Human Use, Feb-2006: http://ec.europa.eu/health/files/eudralex/vol-10/12_ec_guideline_20060216_en.pdf
Commission Guideline: European Clinical Trials Database (EUDRACT Database) and Amendments, Apr-2003: http://ec.europa.eu/health/files/eudralex/vol10/13_cp_and_guidance_eudract_april_04_en.pdf
CHMP Guideline CHMP/QWP/185401/2004: the Requirements to the Chemical and Pharmaceutical Quality Documentation Concerning Investigational Medicinal Products in Clinical Trials, 31-Mar-2006: http://ec.europa.eu/health/files/eudralex/vol-10/18540104en_en.pdf
The Rules Governing Medicinal Products in the European Union Volume 10 - Guidance Documents Applying to Clinical Trials Guidance on Investigational Medicinal Products (IMPS) and 'Non Investigational Medicinal Products' (NIMPS), 18-Mar-2011: http://ec.europa.eu/health/files/eudralex/vol-10/imp_03-2011.pdf
Commission Guideline on Recommendation on the Content of the Trial Master File and Archiving, Jul-2006: http://ec.europa.eu/health/files/eudralex/vol-10/v10_chap5_en.pdf
Commission: Guideline - Ethical Considerations for Clinical Trials on Medicinal Products Conducted with the Pediatric Population, Jan-2008: http://ec.europa.eu/health/files/eudralex/vol-10/ethical_considerations_en.pdf
EMA/121340/2011: Reflection Paper on Ethical and GCP Aspects of Clinical Trials of Medicinal Products for Human Use Conducted Outside of the EU/EEA and Submitted in Marketing Authorization Applications to the EU Regulatory Authorities, 16-Apr-2012: http://www.emea.europa.eu/docs/en_GB/document_library/Regulatory_and_procedural_guideline/2012/04/WC500125437.pdf
Proposal on a regulation on clinical trial and Repealing on DIRECTIVE 2001/20/EC: http://ec.europa.eu/health/files/clinicaltrials/2012_07/proposal/2012_07_proposal_en.pdf

国际协调会议

Q7, GMP Guide for active pharmaceutical ingredients/10 Nov 2000: http://www.ich.org/products/guidelines/quality/article/quality-guidelines.html
Q9, Quality Risk Management/9 November 2005: http://www.ich.org/products/guidelines/quality/article/quality-guidelines.html
E2A Clinical safety data management: definitions and standards for expedited reporting/dated 27 October 1994: http://www.ich.org/products/guidelines/efficacy/article/efficacy-guidelines.html
E3 Structure and content of clinical study reports/ 30 November 1995 http://www.ich.org/products/guidelines/efficacy/article/efficacy-guidelines.html
E5 (R1) Ethic factors in the acceptability of foreign clinical data/ 5 February 1998: http://www.ich.org/products/guidelines/efficacy/article/efficacy-guidelines.html
E6 (R1) Guideline for good clinical practice/ 10 June 1996: http://www.ich.org/products/guidelines/efficacy/article/efficacy-guidelines.html
E7 Studies in support of special populations: geriatrics/24 June 1993: http://www.ich.org/products/guidelines/efficacy/article/efficacy-guidelines.html
E8 General Considerations for clinical trials/17 July 1997: http://www.ich.org/products/guidelines/efficacy/article/efficacy-guidelines.html
E9 Statistical principles for clinical trials/5 February 1998 : http://www.ich.org/products/guidelines/efficacy/article/efficacy-guidelines.html
E10 Choice of control group and related issues in clinical trials/ 20 July 2000: http://www.ich.org/products/guidelines/efficacy/article/efficacy-guidelines.html
E11 Clinical investigation of medicinal products in the pediatric population/20 July 2000: http://www.ich.org/products/guidelines/efficacy/article/efficacy-guidelines.html

行业链接

CENTERWATCH - Clinical Trials Listing Service: www.centerwatch.com
DIA - Drug Information Association: www.diahome.org
ACRP - Association of Clinical Research Professionals: www.acrpnet.org
RQA- Research Quality Assurance: http://www.therqa.com/
CQAF- China Quality Assurance Forum: http://www.cqaf.gov

资源下载

相关链接