Skip to main content

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  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 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
Labels:

Comments

  1. tharunbi22 February 2018 at 21:22

    This comment has been removed by a blog administrator.

    ReplyDelete
  2. Unknown8 March 2018 at 21:38

    This comment has been removed by a blog administrator.

    ReplyDelete
  3. Unknown11 March 2018 at 22:44

    This comment has been removed by a blog administrator.

    ReplyDelete

Post a Comment

Popular posts from this blog

What is a ‘backward forward convertor’ ?

Did you know that ICH has a backward forward conversion (BFC) tool which was build using eXtensible Stylesheet Language Transformation (XSLTs) ? This language basically transforms a XML file of a given format into another XML file of a different format. The BFC tool requires a program that understands XSLT language to make conversion of E2B (R2) to E2B (R3) and vice versa. Now considering this, the European medical agency has improvised the BFC tool with additional fields as per the EU implementation guide. The EU version of the amended BFC tool has been published on the EMA website. The key files in the BFC package includes downgrade-icsr.xsl; which downgrades E2B (R3) file into E2B (R2) and upgrade-icsr.xsl; which upgrades E2B (R2) file into an E2B (R3) file. The acknowledgement convertors include downgrade-ack.xsl and upgrade-ack.xsl What are the technical limitations of BFC tools? However, the conversion using BFC has some major limitations. When converting I
Post a Comment
Read more

MHRA’s Black Triangle Report

In United Kingdom, there are certain drugs in which although they were granted marketing approval by the Medicines and healthcare product regulatory agency (MHRA), they need to be closely monitored, since limited information were available about these drugs.  One of the key reasons attributed to this may be, less subjects being enrolled in the clinical trials, short therapy duration etc.…thus, in order to identify rare adverse reactions, effect of the drug in different populations or effect of the drug under different co-morbidities, such drugs are tagged with an inverted black triangle ( ▼ ) on their package insert, to ensure that these drugs are intensively monitored. The Commission on Human Medicines (CHM) and MHRA encourages expedited reporting within 15 calendar days of all such drugs with an inverted black triangle symbol if, found to have caused serious or non-serious adverse drug reaction. You may find the black triangle drugs at the Electronic
Post a Comment
Read more

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
5 comments
Read more