I am delighted to connect with you through this May 2014 edition of Oviya MedSafe’s newsletter!
Ever since we released our newsletter’s April 2014 edition featuring Oviya MedSafe’s strategic relationship with UK-based Assured Information Systems Ltd for usage of their Pharmacovigilance Software Database PV247 to manage the drug safety processes of our clients, we have been receiving lots of encouraging inquiries from prospective clients all over the world who truly believe that their problem of cost-effective pharmacovigilance regulatory compliance is now solved for good. We are excited that popular pharmaceutical industry media such as Express Pharma, Pharmabiz, Pharma Bio World, Pharmaceutical Online, The Pharma Times and many more have given due weightage to the news. Please contact me directly if you would like to know more details on how Oviya MedSafe and Assured Information Systems can together help you with your drug safety issues.
I take this opportunity to highlight Oviya MedSafe’s local literature search services, over and above the conventional global literature monitoring activities which are carried out by subscribing to known literature search databases like PubMed, MEDLINE or Embase. Every Marketing Authorization Holder (MAH) is mandated to regularly screen published medical and scientific journals whether they are global or local, to ensure that any mention of their products is properly noted and reported to the competent authorities. It is not possible to produce a single list of local literature that covers all scenarios and products. There are many relevant local publications that are not included in any standard global literature search database such as the ones listed above. It is therefore advisable for a MAH to document their rationale for assuring that relevant local literature is included in their literature surveillance strategy.
We at Oviya MedSafe are experienced in carrying out this activity on behalf of our clients and can broadly manage your literature screening requirements for all your products. Our weekly search is not only limited to identification of individual case safety reports, but also includes detection of potential safety issues. In addition, we carry out ad hoc literature searches for purposes of signal evaluation or for identifying safety concerns for inclusion in PSURs.
While we have come to a time that the Indian mainstream media has started talking about adverse drug reactions in the postmarketing scenario, we need to appreciate the Pharmacovigilance Programme of India for generating this kind of awareness among all the stakeholders of Indian pharmacovigilance. It is evident that the Indian pharmaceutical industry would soon follow suit to fulfill the expectations the public have of it. Oviya MedSafe is determined to proactively support our colleagues in the industry with the highest standards of drug safety services, in line with global regulations.
Before signing off, I am glad to wish you on account of the International Clinical Trials Day which falls on May 20th. On this day in 1747, Dr James Lind, a Scottish physician, conducted the first controlled clinical trial on a group of sailors suffering from scurvy. Through their participation in the study, the sailors contributed to the discovery that Vitamin C was an effective treatment for scurvy.
As an Executive Committee Member of the Indian Society for Clinical Research (ISCR), it is my duty to share with you ISCR’s guide for clinical trial participants titled “Patients First“, which has been released on the eve of the International Clinical Trials Day. I request you to kindly re-share this document among your circles and thereby contribute in promoting the awareness of the need and the benefits of Clinical Research.
Looking forward to meeting you in June 2014 with some more interesting news,
With thanks & regards,
Dr J Vijay Venkatraman
MBBS, F. Diab., MBA
Managing Director & CEO,
Oviya MedSafe Pvt. Ltd.
Pharmacovigilance Consulting & Drug Safety Services
2nd Floor, KTVR Gardens,
220a-3, Marudha Konar Road,
Coimbatore – 641 025.
Tamil Nadu, India.
Office Mobile: +91-82207-63222
Office Phone: +91-422-2444442