Skip to main content

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 +91 9354792868 / +91 9560102587 or email us at medical@thinki.in 

Comments

Popular posts from this blog

Eritrea ranked top by UMC- WHO in ADR reporting

Eritrea an African country located in the north east region on the red coast sea bordering Ethiopia and Sudan, has been reported as the top country in reporting adverse drug reaction through safety reports submitted to global database by the Uppsala Monitoring Centre (Sweden), the collaborating centre for WHO as part of their international drug monitoring programme.
The Pharmacovigilance programme of Eritrea was carried out at maturity LEVEL THREE as per UMC with the assistance of local strength engaged in providing harmonization. Eritrea has identified 11 safety concerns on their medicinal products, which were also published in international peer reviewed journals. The Eritrean work on Pharmacovigilance has been globally acknowledged with insights on revising the policy of Eritrean Healthcare system.
Recognizing the significant contribution made in pharmacovigilance,Eritrea along with Netherlands and Peru has been invited for the upcoming 40th Anniversary of UMC on May 18 to share the…

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…

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…