Post Graduate Diploma in Clinical Research

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Post Graduate Diploma in Clinical Research Program Outline, Calendar and Fee Structure Course Calendar for Start Date of September 18, 2006 Title Course Code Date (Mon.Thurs.) Sept 18-28 Oct 02-13 Oct16-19 Oct 23-26 Oct 30-31 Nov1-2 Nov6-9 Nov13-16 Nov 20-23 Nov 27-30 Dec 4-7 Dec 11-14 Dec 17-21 Jan 8-11 Jan 15-18 Time Comment Phase I 1 Anatomy & Physiology 2 Pathology 3 Molecular Biology 4 Biotechnology 5 Pharmacology Fundamentals and Drugs, Biopharmaceuticals and Medical Devices 6 Pharmaceutical Product Development Phase II 7 Good Clinical Practices (GCP/ICH) Regulations, Guidelines and Standards Governing Clinical Research Worldwide AP01 PT01 MB01 BT01 DBMD02 8:30am-1:30pm 8:30am-1:30pm 8:30am-1:30pm 8:30am-1:30pm 8:30am-1:30pm Two Weeks Two Weeks One Week One Week Two Weeks PPD01 REG01 8:30am-1:30pm 8:30am-1:30pm One Week Five Weeks 8 Clinical Trial Development Protocols and Investigator Brochures Phases I-IV DEV01 8:30am-1:30pm Two Weeks 9 Organization of Clinical Trials 10 Cost Estimate and Resource Allocation in Clinical Trials 11 Monitoring Clinical Trials I 12 Monitoring and Information Technology 13 SOP Writing OCT01 COST01 MCT01 MIT01 MW01 14 Data Acquisition (CRF/e-data) 15 Data Management and Data Resolution 16 Clinical Trial Supplies: Planning, Handling and Disposition 17 Project management and Supervision 18 Laboratory and other trial specific tests: Interpretation and Analysis 19 Drugs and Therapeutics; Future Developments 20 Interpersonal and Negotiation Skills 21 Monitoring Clinical Trials II 22 Biostatistical Methods for clinical Research 23 Auditing clinical Trials/GCP Audits DA01 DM01 CTS01 PM01 LAB01 DDD01 IPS01 MCTII01 IT01 ACTII Jan 22-25 Jan 29-31 Feb 1 Jan 8-Feb 15 Feb 5-8 Feb 24, Mar 3 Mar 10 Feb 12-15 Feb 19-22 Feb26-28 Mar 1 Mar 5-8 Mar 12-15 Mar 19-22 Mar 26-29 Apr 2-12 Apr 16-19 Apr 23-26 8:30am-1:30pm 8:30am-1:30pm 6:00pm-9:00pm 8:30am-1:30pm 9:00am-3:00pm One Week One Week 6weeks – twice a week (Mon.&Wed.) One Week Three Saturdays 8:30am-1:30pm 8:30am-1:30pm 8:30am-1:30pm 8:30am-1:30pm 8:30am-1:30pm 8:30am-1:30pm 8:30am-1:30pm 8:30am-1:30pm 8:30am-1:30pm 8:30am-1:30pm One Week One Week One Week One Week One Week One Week One Week Two Weeks One Week One Week

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