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[e-drug] Management Development Program on Pharmacovigilance, February 2013, India

E-DRUG: Management Development Program on Pharmacovigilance,  February 2013, 

Management Development Programme on Pharmacovigilance in Clinical Research 3-5 
February 2014*

Under the current scenario of adverse effects and the
regulatory environment, hospitals as well as health organizations are
maintain the Pharmacovigilance department/ centers so as to overcome the
unmeet need of drug quality information thereafter maintaining the
standards. The Pharmacovigilance and its approaches are used to study the
effects of drug used in market after its new launch. The aim of the course
is to discuss with participants about diverse methods to evaluate
information from health care providers and patients, to identify new
information about hazards associated with medicine and preventing harm to

The Institute of Health Management Research, Jaipur is an institution
dedicated to improvement in standards of health through better management
of health care and related programmes. It seeks to accomplish this through
management education, training, research, consultation and institutional
networking in a national and global perspective. The institute has been
designated as *WHO collaborating Center for District Health Systems based
on Primary Health Care*. The Ministry of Health and Family Welfare,
Government of India has identified the institute as an *Institute of
Excellence *for training and capacity building. For more information please
visit our website www.iihmr.org.

Course objectives:   The specific objectives of the program are

• Understanding the various aspects of Pharmacovigilance in practice
• Preparing for regulatory inspection
• Pharmacovigilance audit preparation
• Risk management planning for improved post-marketing drug safety surveillance
• Adapting to new EU Pharmacovigilance legislations
• Complying with PV regulations whilst meeting global safety requirements

Course Content: The course consists of the following contents:

• Global Pharmacovigilance Regulations, ICH, EMEA, US FDA directives
• Adverse event (AE) definition, types and reporting
• Causality assessment of adverse event
• Expectedness assessment of an adverse event
• Drug coding, Unbinding & reporting
• Issue work-up of aggregate data-consideration of preclinical, clinical, 
epidemiological, safety database, aggregate analysis
• Design of Post marketing studies
• Periodic Surveillance Update Report/ Annual Safety Report
• National Pharmacovigilance Program & Schedule Y

Target Group: 
The programme is meant for hospital managers, doctors, clinical
pharmacologists, pharmacists and other public health professionals/officials
 from federal/central and state Ministries / Departments of Medical &
Health, government hospitals, corporate and other private hospitals
interested in coordinating/maintaining Pharmacovigilance centers. Accredited
 hospitals having DTCs/PTCs may empower members to expand their knowledge
and hospitals in process of constituting DTCs/PTCs can also nominate their

Training approach; 
The program will use a mix of lecture by resource
persons to introduce the lead concept and encourage active interaction by
the participants through classroom discussions, group work and
presentations. The course will be conducted in English.

Course Coordinator and Faculty
Mr. Rahul Sharma & Mr. Abhishek Dadhich,
IIHMR, Jaipur will be the Course Coordinator. Faculty will comprise of both
national and international experts.

Program Fee:
USD 300* per participant + 12.36% service tax. The fee
covers tuition fee, training material, stay in air-conditioning room
(twin-sharing basis), 3-meals a day and tea/coffee during the program.   For
accommodation on single occupancy basis Rs. USD 20 per night will be
charged extra.

Interested participants may obtain specified “CV Template”
by sending an email at <rahulsharma@gmail.com <atmrum.iihmr@gmail.com>> and
completed CV Template must reach by *January 15, 2014* from foreign
participants and by *January 20, 2013* from Indian participants to the
Coordinator by an email at <rahulsharma@gmail.com <atmrum.iihmr@gmail.com>>
or by post to Institute of Health Management Research (IIHMR), 1, Prabhu
Dayal Marg, Sanganer Airport, JAIPUR - 302 029 (India), or by Fax at +91
141 3924738. An earlier date for foreign participants is being kept to
facilitate timely issue of visa supporting letters.

A certificate of participation on completion of the
program will be issued by Institute of Health Management Research, Jaipur.

Course Coordinator:
Rahul Sharma, M.Pharm, PGDCR
Assistant Professor (Pharmaceutical Management)
Indian Institute of Health Management & Research (IIHMR)
A WHO Collaborating Center
1, Prabhu Dayal Marg, Sanganer Airport, JAIPUR 302 011 (India)
Tel: +91 141 3924700 Extn 733, Fax: +91 141 3924738; Cell: *+91 8058829298
Email:  *rahulsharma@iihmr.org <rahulsharma@iihmr.org>*    Web:
Alternative email: rahulsharma1in@gmail.com

Abhishek Dadhich, M.Pharm, M.B.A.
Assistant Professor (Pharmaceutical Management), IIHMR, Jaipur, India
 Email: abhishek@iihmr.org
rahul sharma <rahulsharma1in@gmail.com>

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