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Home » Education & Learning » Professional Studies » Medical & Pharma
Integrated PG Diploma in Clinical Research & Regulatory Affairs 
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Location : Andhra Pradesh » Hyderabad » Ameerpet
Posted on : 14-Nov-2009
Mode: Class Room – Weekend classes – Saturday & Sunday
Duration: 6 months
Fee : Rs.1,00,000/-(Can be paid in two terms)
Location : Hyderabad
Methodology: Weekend Classroom Contact Program; Printed Training Modules; Online
Learning System
Job Assistance: Placement supported would be provided to the successful students.
Program Details:
Semester 1
Group 1 :Clinical Research Introduction
Group 2: Principles of Pharmacology & Drug Discovery & Development
Group 3 :Roles & Responsibilities of Key Stakeholders
Group 4: Preparations & Planning for Clinical Trials
Group 5: Essential Documentation in Clinical Research & Regulatory Submissions
Group 6: Clinical Trials Project Planning & Management
Group 7: Study Start Up Process
Group 8: Clinical Monitoring Essentials
Group 9: Compliance, Auditing & Quality Control in Clinical Research
Group 10: Clinical Data Management, Biostatistics, Analysis & Reporting
Semester 2
Group1: Introduction
Group2: Regulatory Submission and approval
Group3: CTD documentation and preparation.
Group4: Document preparation for license application.
Group5: Preparation for Inspection and audit from regulatory agencies
Group6: Query and complaint handling of regulated market.
Group7: Preparation and review of documents required
Related to : Classroom clinical researc programs, Clinical research, Regulatory Affairs, Clinical research diplamo course
Contact : Satish Bhuvanasi
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