cliniminds

Aca de my for Clinic al Re se a rc h Training &Mana ge ment

INTEGRATED POST GRADUATE DIPLOMA IN CLINICAL RESEARCH &

PHARMACOVIGILANCE

PROGRAM CERTIFIED & ACCREDITED BY THE PHARMACEUTICAL SOCIETY OF

INDIA

Course Commencing : 2nd Week of August 2009 – Classroom

(Program also available through Distance Learning)

Limited Scholarships Available

Cliniminds is pleased to announce India’s first integrated program in Clinical

Research & Pharmacovigilance.

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.
 cliniminds
Aca de my for Clinic al Re se a rc h Training &Mana ge ment

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: Class Room – Weekend classes – Saturday & Sunday

Duration: 6 months

Fee : Rs.100,000/- (One lac only) – Classroom

Location : Delhi & Hyderabad

Methodology: Weekend Classroom Contact Program; Printed Training Modules; Online

Learning System

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
 cliniminds
Aca de my for Clinic al Re se a rc h Training &Mana ge ment

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

Fee Payment :

Fee payable by cheque / cash / bank draft in the name of ‘Tenet Health Edutech Pvt.
Ltd.’ payable at Delhi. We also accept Online Credit Card payments.

Loan Facility : Loan Facility from HDFC Bank is available.

Contact Details :

Cliniminds - Unit of Tenet Health Edutech Pvt. Ltd.; C-55 Preet Vihar, 1st Floor, Main
Vikas Marg, Delhi 110092; India

Tel : +91- 11- 30287 799 – 804; Mobile No. : +91-9818466940; 9871072560; 9810068241;
9873888671; Fax : +91- 11- 4242 7802; Email : info@cliniminds.com; Website :
www.cliniminds.com