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Showing posts from October, 2017


FOR HEALTHY US The ever changing environment and day to day stress starting from the childhood for securing higher grades leading up to the never ending demands of the boss pushing for more. Everyone today is either already been affected by some or the other type of medical condition or is at the high risk of developing one. 

The major sufferer is the health of an individual, which affects the individual’s quality of life and hampers the growth of the nation too. But thanks to the professionals involved in the health services that we are constantly able to manage our health and stay fit. Clinical Research plays an important role in offering us the solutions to our health challenges with safe drugs and devices. 
Scientists conduct Clinical trials, a research study that tests how well an intervention works in a group of people. It tests for new methods of screening, prevention, diagnosis or therapy. Clinical trials are conducted in different phases, ADR Reporting during which additiona…

ZINBRYTA to face restrictions on use, following a safety review by EMA showing serious liver damage

Multiple sclerosis (MS) is condition in which the immune system attacks myelin sheath, which may eventually damage the neurons and leave scar tissue, relapsing multiple sclerosis is a type of sclerosis in which there is flare up following remission, which means during the relapsing phase, the symptoms of MS will partially or completely go away. 
daclizumab is a type of Interleukin 2 receptor (IL2R) antagonist which is used in the treatment of MS. (Interleukin is a type of Cytokine which binds with IL2R to generate immune responses, a type cell signalling) daclizumab was administered as an injection under brand ZINBRYTA, which was first approved by FDA on 27th May 2016, however recently the Pharmacovigilance Risk Assessment committee (PRAC), a part of European Medical Agency recommended restrictions on using daclizumab, due to safety issues associated with serious liver damage (as reported in a clinical trial where 1.7 % subjects developed serious liver reaction, a suspected unexpected …

Why is E2B Validation important?

In Pharmacovigilance -Case processing after completing the data entry process and before routing the case to the next workflow (Medical Review), it is mandatory for everyone to do a Validation check called as E2B validation, E2B validation error could also be an error associated with a special character in case study narrative or in adverse event, further if an error is reported on Validation check which cannot be rectified, a comment stating ‘E2B validation was noted and bypassed’ should be used contact log
Every wondered why?
Every ICSR (Individual case safety report) as per 21 CFR 314.80 in US and Schedule Y appendix XI in India, should be transmitted from the reporting sources to the regulatory authority and this process is also known as E2B submission (as we submitting E2B files) and because one of the mode of transmission is via XML format, if a special character found in the ICSR which is not rectified after the ICSR is converted into an XML file and upload as an E2B file in th…

Vank's disease: A compelling need to decrease Anti Tubercular (TB) drug resistance

Tuberculosis is an infectious and contagious disease caused by a bacteria called Mycobacterium tuberculosis. Tuberculosis primarily affects the lungs, symptoms include: chronic cough with blood in Phlegm, fever.

Pharmacovigilance imparts a vital role in monitoring serious Adverse drug reactions (ADRs) in TB patients who are on treatment in national TB program.
ADRs could lead to a tuberculosis (TB) patient interrupting treatment before completion, and can thus contribute to avoidable morbidity, drug-resistance, treatment failure, reduced quality of life, or death.
Tuberculosis is completely curable using short term chemotherapy called DOTS or Directly Observed Treatment Short course. However, there are several challenges encountered by patient to get DOTS treatment in India. Some of the challenges include coping up with DOTS strategy. In a recent research paper published by (research, team name), it had a study which in which TB patients were interviewed, the paper says ‘Poor patients…

Pharmacovigilance system- Industry perspective, Market size and Operations

Monitoring adverse drug reaction is an essential component in patient safety. In the last decade we have seen how technology has influenced the entire healthcare system, leading to patient awareness, thus making the pharmaceutical companies and regulatory authorities to invest more time and resource in monitoring adverse events.
Pharmacovigilance as per WHO is defined as the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem Pharmacovigilance is the study of adverse events taking into account all the plausible relationship or untoward medical occurrence which the patent experienced after taking the drug and then using standard set of coordinated activities which involves first collecting adverse event reports either via telephone, email, social network, lay press , media. After adverse event reports are filed we then process and assess these reports in database to determine if indeed these adv…

Pharmacovigilance Market to grow exponentially crossing 6 Bn $ by 2020

Pharmacovigilance is Booming with its market size expected to expand at a CAGR of 14.2% through 2020. In 2014 the market was at 2,75 Mn $ which is now expected to reach 6,10 Mn $ by 2020.

It is believed that the growth is attributed to CAGR of 15.5% in Phase III clinical trials, further needless to say that 57% of global pharmaceutical companies outsource their projects to contract research organization.   

Outsourcing trend of pharmaceutical companies has projected increase the market size of Pharmacovigilance, which in turn benefits the not only the vendor (by creating more job opportunities) , it also benefits the Pharmaceutical giants by increasing their capitalization by working on shorter turn-around time and also avoiding operational cost in Talent acquisition and Infrastructure for carrying drug safety operations.


Chat Bot- the first artificial intelligence bot in Pharmacovigilance

Merck Sharp & Dohme (MSD) Corp., a subsidiary of Merck & Co., Inc has developed an Artificial Intelligence (AI) chat bot. The MSD Salute chat bot is designed to aid physicians in providing product information and pathology. 
The Physicians who are registered with MSD would use the Chat bot using facebook messenger.  Chat bot is derived from the social media and uses machine learning and implements feedback to develop interactions. 
Currently MSD is monitoring and not filtering the communication between Chat bot and users, as they want to analyse the open ended exchanges between the AI and the users. Chat bot currently in the testing phase, is said augment patient safety through proactive pharmacovigilance
We at Think I are also driven to produce Pharmacovigilance safety database solutions using cloud based technology which are not only cost effective and user friendly but also fully validated for quick, easy import, entry and electronic submissions of adverse event. 
For mor…

India’s first own android app to report adverse reactions

The Indian pharmacopeia commission (IPC) has developed an android based application for reporting adverse drug reactions. The app under the name PVPI ADR would facilitate auto filling of data with easy attachments of source documents/ image files comprising of laboratory test reports etc. and would generate XML files, facilitating E2B submissions. The app could be easily used by both health care professionals and consumers.

Under the ‘Pradhan Mantri Kaushal Vikas Yojana’  a Skill development programme was organized where by , the IPC , National coordinating centre- Pharmacovigilance programme of India (NCC PvPI) under the Union Health Ministry have trained 300 physicians and pharmacist.
India is transcending as one of the nations with robust pharmacovigilance and patient safety systems.
We at Think I are also driven to produce Pharmacovigilance safety  database solutions using cloud based technology which are not only cost effective and user friendly but also fully validated for quic…