Clinical research

							              PHARMASRI CLINICAL RESEARCH




                                   PHARMASRI




      Clinical Research                                          Pharmacovigilence
          Associate                    Clinical Data
                                       Management




1. Clinical Research Associate

 A.   Fundamentals of clinical research
 B.   Drug Discovery and Development
 C.   Clinical Research Process
 D.   Bioavailability and Bioequivalence
 E.   Clinical Research- Ethics
 F.   Regulatory bodies
 G.   Computers in Clinical research
 H.   Clinical trial process and management of clinical trials
 I.   Audits in Clinical trial
 J.   Documentation –Clinical Research
 K.   Essential documents in Clinical Research
 L.   Cold chain management
 M.   Six sigma-Clinical trials
 N.   Clinical Research- Outsourcing
 O.   Statistics in Clinical Research
 P.   Quality Control and assurance
 Q.   Clinical Research-Finance
 R. Design of protocol and SAP


2. Clinical Data Management
 A. Introduction
 B. CRF design
 C. Data base design
 D. Data validation Specifications
 E. Self evident corrections (SEC) , Data handling convention
 F. Types of data entry
 G. Discrepancy Management,
 H. Creation and Resolution of Data Clarification Forms
 I. Data acquisition, Data validation procedures
 J. 21 CFR part 11
 K. SOP,s
 L. Data protection
 M. Paper vs EDC
 N. QC process/QA process
 O. Medical coding
 P. Statistical analysis and reporting



3. Regulatory Affairs

   Introduction
   Types of regulatory affairs, DCGI, CDSCO, FDA, ENVISA
   Ethics Review
   Informed consent process
   Integrity, misconduct and conflicts in Clinical research
   Identification of new drugs
   Invitro studies
   In vivo studies in animal models
   Application to CDSCO
   Approval requirements
   Biologics
   Regulatory Requirements
   DCGI guidelines
   Data analysis and reporting
   Difference between ANDAs and NDAs, Orphan drugs
   Role of Drug regulatory authority, audits, notices, warning letters
   Legal implications, requirements in other countries
   MeGuide, Kefauver-harris amendments, Waxman-hatch Amendments
4. PHARMACOVIGILENCE

5. CLINICAL SAS PROGRAMMING

6. PATENT ANALYSIS

7. QULAITY ASSURANCE IN CLINICAL TRIALS



Duration : 2 MONTHS
Timings : SATURDAY AND SUNDAY (7 HRS PER DAY )
Fees      : 15, 000
Place     : Hyderabad, Bangalore
* Batch will start once 15 students enroll
* Training by Industry professionals (More than +5 years experience)

www.pharmasri.com      mail : info@pharmasri.com