What is an IDMP and its application in Pharmacovigilance?

In response to the demand for internationally harmonized detail of medicinal products, the IDMP which comprises of a set of five ISO norms provides the basis of identifying medicinal products. IDMP standard readily facilitates ICSR (Individual Case Safety Report) submission to regulatory agencies.

The message specification in IDMP protects the integrity of medicinal product information when submitting cases to the regulatory agency. HL-7 transmissions are within the IDMP standards Health Level 7- is an international standard for facilitating data exchange between the safety/ clinical database and the regulatory agency.

The five ISO norms comprise of

ISO 11238 pertains to general characteristics of regulated medicinal products specifying where the product is an active pharmaceutical ingredient or an adjuvant. ISO 11238 also describes the grade of product used (purity, manufacturing information etc.…)

ISO 11239 pertains to regulated information on packaging, dosage form, route of administration etc.

ISO 11615 pertains to marketing authorization status of the medicinal product.

ISO 11616 pertains to reference units and strengths of the medicinal product.

ISO 11240 pertains to units of measurement and traceability of identification of medicinal products (IDMP).

With the purview of upcoming advances in Pharmacovigilance, we at Think I would like to present our state of the art, cost-effective, robust and secure software as a solution (SaaS) for Drug safety, Medical Devices safety, Vaccine safety, Cosmetics, and Nutritional product safety.

For more details, please visit www.thinki.in or contact us for a DEMO at email us at medical@thinki.in

Comments

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 adve

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 indee

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 intellig

Search This Blog