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Similar a Careers In Clinical Research Industry Gp 06 Nov11
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- 1. A quick road map Gopal Pai, Ph.D. Head, Clinical Operations, Clinigene International Limited (A Biocon Company), Bangalore
- 2. Out-sourced / In-sourced / Combination Customer Focus Respect for People Integrity Innovation Teamwork Leadership Performance Community
- 7. In Vitro Screening Tests
- 8. In Vitro Screening Tests Animal Model Screening Tests
- 9. In Vitro Screening Tests Animal Model Screening Tests Pre-clinical Animal Toxicity Studies
- 10. In Vitro Screening Tests Animal Model Screening Tests Pre-clinical Toxicity Studies Sub-Acute & Acute Chronic Animal Safety Studies
- 13. Acute & Sub-Acute Chronic Animal Safety Studies Pharmaceutical Development Clinical Development
- 20. International Scientific & Ethical quality Standard DESIGN REPORT RECORD COLLECT Patient Safety Credibility of Data Execute Verify Analyze Publish / market Services Audits & Inspections
- 21. Declaration of Helsinki ICH-GCP Local regulations Protocol, SOPs
- 26. Synopsis Reg. approval pre-study inv. meet Idea Idea Final Protocol Final CRF Drug Supply Inv. & site selection Final Report Safety Monitoring Data processing & analysis Close-out Inv. Meet & EC approvals Site Initiation Monitoring Audits & inspection
- 27. Project Manager SPONSOR REGULATORY BODY Senior mgmt approval Study Monitor Investigator Central Laboratory Patients Labs / Services Data management & Biometrics Vendors CRA CRA CRA CRA Ethics Committee
- 28. Hospital / Institute Investigator Contract Research Organization Sponsor
- 36. Dept: Administration Junior - Senior positions Min: G/PG (event managers/ travel agents) Dept: Ethics Committee Very senior positions Min: composition per ICMR guidelines (highly qualified and experienced individuals only) Inv. Meet & Ethics Committees Site Initiation Monitoring Quality Audits & Govt. inspection
- 51. CHALLENGES IN DRUG DEVELOPMENT GLOBALLY
- 55. Once a very noble profession……
- 57. … NOW PERCEIVED AS A GUINEA PIG SYNDROME ! Help !!! Help !!!
- 58. Pre-World War II Empiric Rx Evidence-Based Medicine Personalized Medicine Post-World War II … the future?
- 59. as much “ art ” as it is “ science ” much of evidence-based medicine is a “ gold-standard in treatment approaches”, keeping the "art" aspect in mind … is as good an approach as any to determining whether evidence-based medical study results are useful to you as you and your doctor consider possible treatment for whatever your medical problem is. “ Art” factor
Notas del editor
- 16 We take pride in our integrity as a company that improves people’s lives. We are devoted to maintaining top performance through teamwork . We value innovation in our products and leadershi p in our groups. We are committed to serving the communities around us. We are a corporation with a high respect for people and a sharp customer focus . These are our values at Pfizer.