Date: 2022-09-29Category: Not ApplicableState: Union GovernmentCountry: India
Strengthening of Medical Products Safety Surveillance System in North Eastern States of India on October 19 2022 at Government Pharmacy College Sajong Sikkim
**Executive Summary:**
The conference aims to raise awareness about the regulation and safety surveillance of medical products among manufacturers, importers, distributors, healthcare professionals, researchers, and academicians in North Eastern India. It is jointly organized by the Indian Pharmacopoeia Commission (IPC) and Government Pharmacy College Sajong (GPCS). Participation is based on a first-come, first-served basis, with a maximum of 200 seats. Payment is only accepted after confirmation from IPC.
**Key Points / Main Content:**
* **Objective:**
* Create awareness about the regulation and safety surveillance system of medical products in North Eastern India.
* Ensure the quality and promote the safety of medical products.
* **Background:**
* IPC is responsible for the Pharmacovigilance Programme of India (PvPI) and Materiovigilance Programme of India (MvPI).
* PvPI and MvPI aim to improve patient safety by monitoring, recording, and analyzing adverse events related to medical products.
* GPCS was established in 2018 with the vision of building careers in pharmaceutical sciences.
* **Target Audience:**
* Manufacturers, distributors, and importers of medical products.
* Healthcare professionals, researchers, and academicians.
* **Conference Benefits:**
* Strengthening of the medical products safety surveillance system in North Eastern India.
* Informed decision-making for stakeholders through information dissemination.
* Engagement of academia in post-market surveillance studies.
* **Registration:**
* Professionals from online industries, government hospitals, institutions, and corporate hospitals can register.
* Registration fees:
* Rs. 2,000 (Government/Private) including 18% GST.
* Rs. 1,000 including 18% GST.
* Maximum 200 seats available.
* Participation based on first come first serve basis.
* Payment is only accepted after confirmation from IPC.
**Impact Analysis:**
* **Medical Product Manufacturers, Distributors, and Importers:**
* *Impact:* Increased awareness of regulations and safety surveillance systems, potential changes to practices to ensure product safety and compliance.
* *Action Required:* Attend the conference, implement necessary changes to comply with regulations, and actively participate in safety surveillance reporting.
* **Healthcare Professionals:**
* *Impact:* Enhanced knowledge of medical product safety and adverse event reporting, improved patient safety practices.
* *Action Required:* Attend the conference, report adverse events, and stay informed about updated regulations.
* **Researchers and Academicians:**
* *Impact:* Opportunities to engage in post-market surveillance studies and contribute to improved medical product safety.
* *Action Required:* Participate in research initiatives, contribute to the understanding of medical product safety, and disseminate findings.
* **Regulators:**
* *Impact:* Improved data collection and analysis for informed decision-making and regulatory action.
* *Action Required:* Utilize the information gathered through the surveillance system to enhance regulations and promote patient safety.
Key Entities Referenced
Indian Pharmacopoeia Commission IPC: An autonomous body of the Ministry of Health and Family Welfare, Government of India, responsible for National Coordination Center NCC responsibilities related to Pharmacovigilance Programme of India PvPI and Materiovigilance Programme of India MvPI.
Pharmacovigilance Programme of India PvPI: A program coordinated by IPC to improve Indian patient safety by monitoring, recording, and analyzing the root cause of adverse events or risks associated with the use of medical products.
Materiovigilance Programme of India MvPI: A program coordinated by IPC to improve Indian patient safety by monitoring, recording, and analyzing the root cause of adverse events or risks associated with the use of medical devices.
Government Pharmacy College Sajong GPCS, Rumtek, Sikkim: A pharmacy college established in 2018 under the Health and Family Welfare Department, Government of Sikkim.
Sikkim University: The Central University to which Government Pharmacy College Sajong GPCS, Rumtek, Sikkim is affiliated.
Pharmacy Council of India PCI: A council that has approved the Government Pharmacy College Sajong GPCS, Rumtek, Sikkim.
All India Council for Technical Education AICTE: A council that has approved the Government Pharmacy College Sajong GPCS, Rumtek, Sikkim.
North Eastern States of India: A geographical region in India that is the target of the conference, for awareness about the regulation and safety surveillance system of medical products.
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October 10, 2022
Jointly Organized byOBJECTIVE
The objective of the conference is to create awareness about the regulation and safety surveillance system of medical
products among manufacturers, importers, distributors, healthcare professionals, researchers & academicians of North
Eastern States of India, in order to ensure quality & promote the safety of medical products.
BACKGROUND
¢ Indian Pharmacopoeia Commission (IPC), an Autonomous body of Ministry of Health and Family Welfare,
Government of India, has entrusted with National Coordination Center (NCC) responsibilities related to
Pharmacovigilance Programme of India (PvPl) and Materiovigilance Programme of India (MvPI) since 2010 and 2018,
respectively, with an objective to improve Indian patient safety by monitoring, recording and analyzing the root cause of
adverse events or risks associated with the use of medical products including drugs, vaccines, medical devices and in-vitro
diagnostics and suggesting regulatory bodies for appropriate action with the sole intention of promoting patient safety.
PvPI and MvPI program aims to promote and facilitate the adverse event reporting of medical products including drugs,
vaccines, medical devices and in-vitro diagnostics respectively and subsequently evaluating these events.
¢ Government Pharmacy College Sajong (GPCS), Rumtek, Sikkim established in 2018 under the aegis of Health and
Family Welfare Department, Government of Sikkim with the Gazette notification No 331 dated 20.06.2018. The
college is affiliated to the Central University i.e. Sikkim University and approved by the Pharmacy Council of India (PCI)
and All India Council for Technical Education (AICTE). The college was started with the vision of building the career of
youth in pharmaceutical Sciences as the backbone of the healthcare system to impart their services in industry, academia,
hospitals, community, research and development for novel medicines and improve healthcare outcomes. Institute mission
is to establish a “Centre of Excellence” in pharmacy education research & development, community practice and clinical
services at the national and International level. The institute in pursuit of its vision and mission will provide outstanding
education in pharmaceutical sciences through its learned and experienced teachers including a supportive environment
for scholarship, research and integrity.
Manufacturers, distributers, importers of medical products including drugs, vaccines, medical devices and in-vitro diagnostics,
healthcare professionals, researcher & academicians can attend this conference.
¢ Strengthening of medical products safety surveillance system in North Eastern States of India.
¢ This conference will help in decision making for medical products manufacturers, distributors, importers of medical products,
users, and regulators by disseminating information on existing regulation in the country, make them aware about existing safety
surveillance system in India, to engage academia in study of post market surveillance of medical products.