Thursday, 15 June 2017

Cliniminds- Leaders in Pharmacovigilance Corporate Training

Cliniminds was recently engaged in providing corporate training to one of the leading IT Company who are pioneers in providing pharmacovigilance software solutions. Our training was conducted through online learning mode, we had participates connected with us globally (Europe, Japan and India). 

The training involved a series a 15 sessions which focussed on key areas of pharmacovigilance like, MedDRA, Case processing, Medical review of ICSR, Aggregate reporting, Signal detection, E2B submissions, Vaccine safety, Quality assurance and, were conducted by a panel of subject matter experts from leading pharmacovigilance organization.
The training involved online assessments, case studies and practical session to gauge each participant’s performance. We also ensured that our participants were provided with hard-copied printed books and online access to our content which included PowerPoint presentations and research notes.

The training program was concluded with final assessment upon the completion of which each participant was awarded with Advanced Post Graduate Diploma in Pharmacovigilance accredited from ACCRE, USA

CLINIMINDS-accredited from ACCRE, USA, has been on forefront in providing corporate trainings to leading pharmaceutical clients and has been awarded as the Best Clinical Research & Health Sciences Business Management Institute consecutively for six years - 2011, 2012, 2013, 2014, 2015 and 2016 by leading agencies including ASSOCHAM.

For more details contact us at +91-9810068241; info@cliniminds.com or visit us at www.cliniminds.com

Tuesday, 6 June 2017

Audit Contingency & Form 483

We have quite often heard about the contingency plan for an Audit, especially when it is a regulatory inspection, like by the US FDA (United States Food and Drug Administration) or MHRA (Medicines and healthcare product regulatory agency). 


Claris recently underwent a regulatory inspection by the US FDA and was given the green flag with no observations reported.


With compliance being the utmost priority for every inspection, It has become essential for every Marketing Authorization Holder (MAH) to have an audit response team, which would capable and qualified to understand all the norms and requisites for a regulatory visit.


Over the past several years it has been observed that FDA has been proactive in constantly monitoring ADR and compliance which has led its issuing of ‘Form 483 warning letters and citations’ to many companies. 




Form 483 refers to the 21 United States Code (USC) part 374 which authorizes US FDA to conduct ‘Inspectional observation’ and ‘Factory Inspection’, It is therefore ideal that every MAH should have an SOP on inspection readiness for both regular and targeted audits.


We at Think I are also engaged in providing training in Quality Assurance, Audits and Inspection. Our team comprises of seasoned subject matter experts from pharmacovigilance Industry.


We provide Pharmacovigilance safety solutions using cloud based technology which are not only cost effective and user friendly but also fully validated meeting all the compliance checkpoints facilitating  quick, easy import, entry and electronic submissions of adverse event. 


For more details, contact us at +91 9560102587, +91 9810068241 or 
email us at medical@thinki.in or simply visit www.thinki.in


Joseph Mathew
Sr. Manager-Think I


Drug Safety and Brexit

There have been talks about what would happen once UK leaves EU which has put lot of QPPV (Qualified Persons Responsible for Pharmacovigilance) in UK in dilemma as the regulations say that the QPPV should be a part of the EU, with the impact Brexit it will hit the pharmacovigilance system in UK as EU would not be obliged to carry out Post marketing surveillance in UK.



Currently June Raine who is chairing the Pharmacovigilance Risk Assessment Committee ( part of the European Medical Agency, in which there are two members from each member state) is from the Medicines and healthcare products regulatory agency (MHRA) of the UK.


There have been discussions about QPPV who still want to be a part of EU which might eventually lead to a negotiation between EMA and UK to collaborate pharmacovigilance activities together, as pharmacovigilance is above politics.

By Joseph Mathew
Sr. Manager- Think i


About us:
We are an organization providing technological solutions and result oriented quality services in Pharmacovigilance, Clinical Trials, Medical Writing, Drug Regulatory Affairs and Human Resources.
We provide cloud based software solutions for pharmacovigilance 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 more details, contact us at +91 9560102587 or +91 9810068241

The ‘new’ EUDRAVIGILANCE

European Medical Agency would be releasing a new version of EudraVigilance system, which is expected to go live in November 2017, EMA in their report mentioned that they would be publishing a checklist of readiness for all the stakeholders to prepare them for the changes which will come along with the launch of the revised version of EudraVigilance, for which EMA also intends to provide eLearning modules, support webinars and face to face training.


The prototype of EudraVigilance test environment or XCOMP is already scheduled to be released June 2017 which will let all the National competent authorities to test Individual case safety reports in E2B R3 versions.



We at Think I are also driven to produce Pharmacovigilance safety 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 more details, contact us at +91 9560102587, +91 9810068241 or email us at medical@thinki.in or simply visit www.thinki.in

Joseph Mathew

Sr. Manager-Think I

Friday, 12 May 2017

INDIA - A need to develop our own In house safety database solution

In the recent times we have seen a growing prevalence of diseases and chronic disorders, in order to eradicate life threatening diseases and chronic conditions, we have made one leap forward towards developing an effective pharmacovigilance system, with the sole aim to provide robust patient safety, through monitoring adverse drug reactions, signal detection and risk management plan.




Collection, detection, assessment and monitoring of adverse event through ICSR’s (Individual Case Safety Reports) requires specialized IT framework with the capabilities of Intelligent Automation for computing frequency of adverse events using complex algorithms and statistical disproportions, which will help us then to understand the benefit-risk profile of the drug, paving way for an effective risk management plan.


With PvPI facilitating drug safety activities in India, In the current scenario there is an strong need for collaboration of IT segment with PvPI to build an in house safety solution which will encompass all the capabilities for carrying out end to end pharmacovigilance process and at the same time it should be made available for patient/ healthcare professionals as a cloud based services or android/IOS service for direct reporting of adverse events.


This service could be linked to Aadhar card, where in which a patient or HCP when reporting an adverse event, by simply entering the telephone number or UID will get an OTP on their smartphone and then after providing the OTP, the end user would have complete access to his/her own database which would include the number of previous adverse event reports submitted, current status of reports, this would also enable auto filling of contact details in adverse event monitoring using machine learning.





Brought to you by Think-I - an organization providing technological solutions and result oriented quality services in Pharmacovigilance, Clinical Trials, Medical Writing, Drug Regulatory Affairs and Human Resources.


We provide cloud based software solutions for pharmacovigilance 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 more details, refer to product brochure or contact +91 9560102587 or +91 9810068241
Email: medical@thinki.in ; www.thinki.in




Friday, 31 March 2017

Safety Database Solution – more than a software…

With the evolving trend of technology in drug safety and with invent of intelligent automation and machine learning we at Think I would like to proudly present its Partnership with AB Cube.

A company which provides cloud based software solutions for vigilance which are not only cost effective and user friendly but also fully validated for quick, easy  import, entry and electronic submissions of adverse event in Human Drugs, Medical Devices, Cosmetics, Nutraceuticals and veterinary products.



Key features include:

·         Unlimited number of users with one time implementation cost.
·     Safety solutions are FDA 21CFR part 11, E2B (R3), HL7 complaint and Validated according to GAMP 5 (Good automated manufacturing practices), full validation dossier provided.
·         Generation of PBRER and Signal Detection.

Apart from these recherché features :

AB Cube also provides training on their software solutions through e learning, virtual and Face to Face and also facilities extensive support 24/7 through service ticket or phone with response time less than 2 hours to its valued customers.   

So what are you waiting for!  Get complaint, get AB Cube

AB Cube … more than a software

Brought to you by Think-I - an organization providing technological solutions and result oriented quality services in Pharmacovigilance, Clinical Trials, Medical Writing, Drug Regulatory Affairs and Human Resources.

For more details, refer to product brochure or contact +91 9560102587 or +91 9810068241

Thursday, 13 October 2016

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 residing in rural areas faced the greatest difficulty in overcoming the barriers. They had to travel long distances every alternative day to reach a DOTS centre, had to put up with inconvenient timings’ and “unfavorable attitude” of the staff.



Lack of proximity to a DOTS center, inconvenient timings, and lack of patient awareness eventually leads to Multi-drug-resistant tuberculosis, specifically prominent in Patients from rural parts of country.


Multi-drug-resistant tuberculosis or Vank's disease is caused by bacteria that are resistant to treatment with at least two of the most powerful first-line anti-TB drugs.


Treatment to DOTS is now becoming difficult with increase in drug resistance, Pharmacovigilance plays a vital role in drug monitoring for Multi-drug-resistant anti-TB drugs. 


Drug resistance is caused when:

· Patients do not complete a full course of TB treatment


· Health care professional prescribe the wrong treatment (the wrong dose or length of time)


· Drugs for proper treatment are not available


· Drugs are of poor quality


· Further Drug-resistance is more common in people who


· Do not take their TB drugs regularly


· Do not take all of their TB drugs


· Develop TB disease again, after being treated for TB disease in the past


· Come from areas of the world where drug-resistant TB is common


· Have spent time with someone known to have drug-resistant TB disease



Apart from drug resistance patients also experience ADR from the DOTS drug regime ADRs could include hearing loss to dizziness, rashes, anorexia, abdominal pain, nausea, and vision loss. Immediate medical attention is required on a time-bound basis to stop the drug and control the reaction after which an alternate medication is prescribed.



Recently The Pharmacovigilance Programme of India (PvPI), which has identified the SDS TB Research Centre, Rajiv Gandhi Institute of Chest Diseases (RGICD) to monitor adverse drug reactions (ADRs), is now working to have a centre for research and training. The objective is to educate its nurses and doctors on early detection of ADR caused by TB and lung infection medications.


Reference:


By,
Joseph Mathew
Senior Manager- Pharmacovigilance
Cliniminds, Unit of Tenet Health Edutech Pvt. Ltd.
Mobile: +91 9971622264

Wednesday, 12 October 2016

Think-i – www.thinki.in offers end-to-end pharmacovigilance services

Think-i – www.thinki.in offers end-to-end pharmacovigilance services – case processing, aggregate reports, RMP, signal detection, training, medical writing, clinical and non-clinical documents. For more information, please contact bd@thinki.in or +91 9810068241 for further discussion.

Why is E2B Validation important?

Date: 06Oct2016

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 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 the regulatory database while doing the regulatory submission it will not accept the E2B file and prompt back with an error hence it is mandatory to always do an E2B validation. 




Saturday, 31 October 2015

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, during which additional information is learned about an intervention, its risks, and its effectiveness and/or efficacy.


Each study answers scientific questions and helps scientists prevent, screen for, diagnose, manage, and treat a disease. People who take part in clinical trials contribute to the knowledge of how a disease progresses. In the last few years Clinical Research has gone through several changes. Thanks to the new regulations over the past few years, which has proved beneficial for trial participants as it has strengthened ethical processes, improved subject safety and suitable compensation globally. India too with its huge population size and patient pool, is fast becoming the hub for many important clinical trials by global pharma giants.


Scientists and medical community need to make sure the ‘Patient Safety First’. The days like “INTERNATIONAL CLINICAL TRIALS DAY” give us the time to think on our health and ponder on what is being done For Healthy Us.

By Sapna Sharma
M.Phil. - Biochemistry
Senior Manager- Academics & Training CLINIMINDS
http://www.cliniminds.com/presentation/Home.aspx