“let us join hands with pvpi to ensure patient safety” adr ...€¦ · 02/06/2019 · adr...
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“Let us join hands with PvPI to ensure patient safety” ADR Reporting Helpline (Toll Free): 1800-180-3024
Regional Workshop on
"Basics of Pharmacovigilance & Establishment of Pharmacovigilance System in Pharmaceutical Industries - A Way Forward" June 23, 2017 - AIIMS, Rishikesh (10:30 AM to 04:00 PM)
INDIAN PHARMACOPOEIA COMMISSION National Coordination Centre-Pharmacovigilance Programme of India (PvPI)
MINISTRY OF HEALTH & FAMILY WELFARE, GOVERNMENT OF INDIA SECTOR-23, RAJ NAGAR, GHAZIABAD- 201 002.
Tel No: 0120- 2783392, 2783400, 2783401 Fax: 0120-2783311e-mail: [email protected], Web: www.ipc.gov.in
Last Date for Registration : June 19, 2017
Objectives
To sensitize manufacturers, importers, distributors and other stakeholders about the need
for a properly-designed Pharmacovigilance system across the user domain, to monitor
Adverse Drug Reactions (ADRs) aimed at establishing safer drug use in the country.
Background
Medicines’ safety-monitoring is an essential element of the healthcare system. The
Ministry of Health & Family Welfare (MoHFW), Government of India, therefore,
launched a nationwide Pharmacovigilance Programme of India (PvPI) in 2010 to monitor
the ADRs ensuring that the benefits of medicine outweigh the risks associated with its
use. This helps safeguard the health of every citizen of India. Indian Pharmacopoeia
Commission (IPC), an autonomous institution under the MoHFW, has been functioning as
National Coordination Centre (NCC) for PvPI since April 15, 2011. To monitor the
ADRs, Adverse Drugs Monitoring centres (AMCs) have been established across the
country under the PvPI. The PvPI has taken a leap forward during the last five years. The
programme has broadened its scope of activities and influence, providing a stage for
interaction and partnership in the sphere of Pharmacovigilance.
In compliance with the recent amendment to Schedule Y, Drugs & Cosmetics Rules,
1945, vide Gazette Notification No. G.S.R. 287 (E) dated March 8, 2016,
Pharmacovigilance has been mandate for Marketing Authorization Holders (MAHs) in
India. To ensure the effective implementation, there is an urgent need for the MAHs to set
up a Pharmacovigilance system at their site.
About the workshop
The pharmaceutical products are primarily approved by CDSCO, MoHFW and
subsequently licensed for either manufacturing and/or import by Drug Regulatory
Authorities at centre and states for marketing in the country. During pre market test and
trials many adverse reaction related to such medicines may remain unnoticed. When a
larger section of population belonging to various age groups and socio-economic strata
are exposed to such medicines, many undesirable AEs/ADRs may emerge. This has
necessitated the strengthening of pharmacovigilance standards and realization of the
importance of a properly- designed pharmacovigilance system in the pharmaceutical
companies as well as Healthcare system.
The field pharmacovigilance is on the path of rapid growth and its development has
impacted the field of health sciences.
The workshop is aimed at bringing together regulatory authorities and pharma
professionals/experts to discuss the practice of pharmacovigilance in the country. It will
also widen the knowledge spectrum of pharma professionals in the field of
pharmacovigilance.
Target Audience
Professionals in Pharmacovigilance, Quality Assurance (QA) and Regulatory Affairs (RA)
in pharmaceutical companies and Healthcare systems.
Expected Outcome
Creation of an agreeable roadmap for pharmaceutical companies and healthcare providers
for the establishment of a harmonized and sustainable Pharmacovigilance System for
collection, collation and processing of AEs/ADRs.
Registration
Registration fee: Rs 2,000 per participant
On-spot registration fee: Rs 2,500 per participant (subject to availability of seats)
Scanned copy of duly filled and signed Registration Form (available at
www.ipc.gov.in) may be sent to [email protected]
A maximum 100 registrations will be accepted, based on ‘first come first served
basis’
Contact Person
Mr Vipin Sharma (09718329700), email id: [email protected]
Tentative Agenda
Of
Regional Workshop
On
“Basics of Pharmacovigilance and Establishment of Pharmacovigilance System in
Pharmaceutical Industries A Way Forward”
Date: June 23, 2017
Venue: All India Institute of Medical Science, Rishikesh
Friday, June 23, 2017
I. Registration (09:30 - 10:30 AM)
II. Inaugural Session
10:30 - 10:40 AM Welcome Address
10:40 - 10:50 AM Opening Remarks
10:50 - 11:15 AM Introduction to Participants
11:15 - 11:30 AM Vote of Thanks
11:30 - 11:45 AM Tea
III. Technical Session
Time Topic Speaker
11:45 - 12:30 AM Pharmacovigilance: Basics, Methods &
Practices
12:30 - 01:00 AM Pharmacovigilance: A legal obligation under D
& C Act, 1940 and Rules, 1945
01:00 - 02:00 PM Lunch
02:00 - 02:30 PM
Set-up of Pharmacovigilance System at
Pharmaceutical companies
02:30 - 03:00 PM
Monitoring & Reporting AEs/ADRs
( Introduction to E2B XML Reporting of ADRs/
AEs to PvPI , Other Forms & Formats)
03:00 - 03:30 PM Engagement of MAHs in PvPI: Current Scenario
& A Way Forward
03:30 - 03:45 PM Tea
03:45 - 04:30 PM Group Discussion