Thursday 29 March 2018

European Medical Agency to increase fees upto 1.7 %

There would be an increase in fees upto 1.7 % from April 1st 2018 as mentioned in the notification of Commission Regulation (EU) No 2018/471 (amending Council Regulation (EC) No 297/95), the fees however would be implemented for all activities carried out by the agency except pharmacovigilance. Apart from Pharmacovigilance the agency has also exempted fees ofMicro Small or Medium Sized Enterprise, Orphan Medicinal Products, Medicinal Products for Paediatric Use, Advanced Therapy Medicinal Productsetc… Detailed information on has been provided on an explanatory note.

The agency every year revises its fees as per the statistical data from EUROSTAT (European Union’s statistical office), the current revision is made in accordance with the inflation rate for 2017.

1.       Explanatory note on general fees payable to the European Medicines Agency
2.       COMMISSION REGULATION (EU) 2018/471 of 21 March 2018
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Clinimindsoffers ‘Hands On training case processing on ORACLE Argus Safety and other safety databases. Our students are entitled for free DIA membership.

Friday 9 March 2018

Artificial Intelligence Seeing through the lens of Pharmacovigilance

Pharmacovigilance as we know is a science with a set of pre defined functions to collect, analyse, monitor adverse event reports in understanding the safety profile of drug.
The set pre defined functions would include case processing through data entry of adverse event forms into safety database, medical review, aggregate reporting, signal detection, risk evaluation and mitigation strategies.

With patients awareness and regulatory compliance we may have seen a surge of adverse event data over last few years , resulting in the urgent need for the application of automation. Pharmacovigilance is the only discipline where in which timelines and quality data are evaluated on a benchmark of 100 % and a compromise in these two parameters are considered to be a zero tolerance.
Automation of above pre defined function is possible through machine learning, which is an integral components of Artificial Intelligence.

What is Artificial Intelligence ?       
Artificial intelligence may be called as an ability of a computer system to perform task that require human intelligence such as cognition through visual acuity, voice recognition, language translation leading to decision execution of a certain function.
Machine learning is based on reinforced data, where in which when an algorithm is executed to accomplish a specific task.

If it accomplishes the algorithm ends and the entire procedure in auto stored in the program, which means next time one does not need to manually execute the program, it would be auto executed in order to accomplish the task, if presented with the exact same variables as that of the earlier scenario.
In the second case if the task is not accomplished then too the procedure would be stored in the program and next time when the program is auto executed it would not take the same path thus minimizing error.

This process self-learning through experience is called machine learning For example imagine a scenario where in which you have you have received an email from a patient who has experienced nausea, followed by headache and bleeding from nose on Lisinopril, the patient also mentions that he has a history renal impairment and also that he was a chain smoker for which he took Varenicline to quit smoking.

An algorithm created on the principle of machine learning would have the capability to auto recognises and identify the suspect drug from concomitant therapy, adverse event from medical history and not only this through robotic process automation it may integrate the email with safety database, which means not only it identifies the suspect drug and the adverse event, it now also does the auto data entry, prepares auto case narrative and auto sends letters to the patient or physician for further follow up  from the safety database.

This is ‘Artificial Intelligence’, a capability attained through self-learning to process thousands of data within seconds.With automation employees engaged in manual data entry would be upskilled in the execution of AI process.

Cliniminds ( ) offers training in aggregate reporting, our students are trained on PSUR, PBRER, Addendum, Summary Bridging, DSUR, ASR, EOS Reports with Hands On’ experience on ORACLE Argus Safety and other safety databases for line listing, summary tabulation extraction.

Thursday 8 March 2018

PvPI to include vector borne disease as part Pharmacovigilance for Public health

Pharmacovigilance programme of India (PvPI), soon to include diseases caused in tropical climate, vector borne diseases like malaria and dengue, tuberculosis and HIV- AIDS as part the Pharmacovigilance for public health. The programme would be soon incorporated by all South East Asian Regulatory Network (SEARN) member countries.

When carrying out pharmacovigilance activities for the above targeted diseases, a common questionnaire has been developed by the  WHO for SEARN countries.

The PvPI would now have an added responsibility of updating adverse drug reaction database on Vigiflow based on the reports received from other SEARN centres.
This indeed shows a remarkable progress of our country- INDIA in translating pharmacovigilance for better patient safety.

Cliniminds offers corporate training programs exclusively designed for working professionals who want to get upskilled in pharmacovigilance, upon the completion of which each participant would awarded with Advanced Post Graduate Diploma in Pharmacovigilance accredited from ACCRE, USA

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