Home > COURSES > Post Graduate Diploma in Clinicall Research & Pharmacovigilance Distance Learning

Post Graduate Diploma in Clinicall Research & Pharmacovigilance Distance Learning

Clinical Research is one of the fastest growing segments of pharmaceutical & healthcare industry. India’s today is most favoured destination after United States to conduct clinical research. There are over 50,000 new jobs being created in the next few years.

Pharmacovigilance is one of the fastest growing segments in the pharmaceutical and clinical research industry. Leading pharmaceutical and lifesciences companies are re-thinking their operating model to drive sustainable growth and productivity. Large number of multinational companies like Bristol-Myers Squibb; Pfizer; Novartis; Qunitiles; GSK have set up the pharmacovigilance centers in India. Number of major IT and consulting firms like Accenture, TCS, Patni etc. have set up pharmacovigilance centers on behalf of several multinational pharmaceutical companies. With the current global recession, large number of global pharmaceutical companies would be looking at India for the PV outsourcing. Apart from international companies, need for the pharmacovgilance professionals will be rising due to regulatory changes taking place in India. Both these factors are now creating large number of new job opportunities in this segment.
Cliniminds has extensive experience in running these programs, and have successfully placed large number of students in the clinical research and pharmaceutical companies. Cliniminds has been running the Clinical Research and Pharmacovigilance Programs for the last few years. Now, we bring the best of our experience in running these programs as a single program due to the demand being created for such programs in the CROs, pharmaceutical companies, KPOs, IT Companies and Hospitals.
Cliniminds has already trained over 500 professionals in the field of clinical research and Pharmacovigilance and has Excellent Placement Record. Cliniminds has conducted number of training programs for the professionals from the companies like Ranbaxy; Novartis; Quintiles; Apollo Hospitals; GSK; Siemens and several other organizations.
In the first phase provide a comprehensive practical knowledge to the clinical research processes, drug development process, regulatory affairs, essential documentation, roles and responsibilities, ethics, monitoring, conduct and management of trials and various other related issues.
In the second phase extensive training on Pharmacovigilance (PV) is the pharmacological science relating to the detection, assessment, understanding and prevention of adverse effects, particularly long term and short term side effects of medicines. In general terms, pharmacovigilance is the science of collecting, monitoring, researching, assessing and evaluating information from healthcare providers and patients on the adverse effects of medications, biological products, herbalism and traditional medicines with a view to:
o identifying new information about hazards associated with medicines
o preventing harm to patients.
The objective is to provide complete understanding of the pharmacovigilance process and to provide working knowledge the students enable them to work in the industry with minimal training.
Mode: Distance Learning
Duration: 11 months
Fee : Rs.40,000/- (Forty thousand only) – Distance Learning – 1 year Program – One week contact program at the end of the program.
Methodology : Online Learning System; Printed Study Material & Contact Program
Eligibility: MD, MBBS, BHMS, BAMS, BDS; Masters / P.hD in Pharmacology; M.Pharm; B.Pharm; and other pharmacology/pharmaceutical, lifesciences graduates and post graduates.
Certificate: Post Graduate Certificate would be awarded at the end of the program. Program is Certified / Accredited by the Pharmaceutical Society of India.
Job Assistance: Placement supported would be provided to the successful students.
Program Details: The program would cover:
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
Group 11 General Overview of Pharmacovigilance
Group 12 Medical Dictionary for Drug Regulatory Activities MedDRA
Group 13 Regulatory Aspects in Pharmacovigilance
Group 14 Diagnosis And Management of Adverse Drug Reactions
Group 15 Medical Evaluation of Adverse Events
Group 16 Quality System in Pharmacovigilance
Group 17 Expedited Reporting Requirements
Group 18 Periodic Safety Update Reports (PSURs) For Marketed Drugs (ICH E2C)
Group 19 Pharmacovigilance Database And Signal Detection Tools
Group 20 Risk Assessment, Evaluation And Management
Group 21 EudraVigilance
Group 22 Suspected Unexpected Serious Adverse Reaction (SUSAR) Reporting
Contact : suprava
Phone : 011-3028 7800
Address : Cliniminds – Unit of Tenet Health Edutech Pvt. Ltd.; C-55 Preet Vihar, 1st Floor, Main Vikas Marg, Delhi 110092; India
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