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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: pvpi.ipc@gov.in, 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 pvpi.ipc@gov.in

A maximum 100 registrations will be accepted, based on ‘first come first served

basis’

Contact Person

Mr Vipin Sharma (09718329700), email id: pvpi.ipc@gov.in

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