3G system in pharmacy practice with vigilance | 5344
Journal of Developing Drugs

Journal of Developing Drugs
Open Access

ISSN: 2329-6631

+44 1478 350008

3G system in pharmacy practice with vigilance

4th International Summit on GMP, GCP & Quality Control

October 26-28, 2015 Hyderabad, India

Khwaja Amtul Raouf Qazi

MRM College of Pharmacy, India

Scientific Tracks Abstracts: J Develop Drugs

Abstract :

India is a hub of global clinical trials and a destination for drug discovery & development. However, whether patients in India receive safe drugs or not is still very much in question. Rapid induction of high tech pharma products in the market throw up the challenges of monitoring Adverse Drug Reaction (ADRs). The complete safety data commonly is captured through Pharmacovigilance. True challenge lies in recognizing the importance & applying current 3G system in pharmacy, i.e., Good Manufacturing Practices, Good Laboratory Practices & Good Pharmacy Practices with vigilance in order to improve public health. This article mainly highlights on Medwatch program & its goal and patient safety. It mainly focuses on adverse effect reporting & producing new safety information to patients. Medwatch is the FDA reporting system for an adverse effect, aimed to detect safety hazard signals for medical products. It deals with pre-market review and approval & post-market monitoring for safety. It also determines the benefit and limitation of clinical trials. It focuses on adverse event monitoring and new drug safety problems. Approaches like��?Yellow Card Scheme for ADR reporting in the UK should also are encouraged worldwide to identifying new information about hazards associated with medicines. Even, mandatory reporting is required by manufacturer to submit the reports to the healthcare provider & post-authorization safety experience should be conducted to ensure the benefits of use of drugs. Thus, it generates a great way towards a safe medical practice.

Biography :

Khwaja Amtul Raouf Qazi has completed her MPharmacy (Pharmacology) from Jawaharlal Nehru Technological University, Hyderabad, with a First Class with Distinction.