Oviya MedSafe – Pharmacovigilance in Patient Safety Narratives for Clinical Study Reports
By admin Dear Colleagues,
As I prepare to fly to Mumbai for Virtue Insight’s 9th Pharmacovigilance 2015 conference, I am proud to spotlight a niche service of expertise that Oviya MedSafe has developed over the past year, through this August 2015 edition of Oviya MedSafe’s newsletter!
The excellence of Oviya MedSafe’s featured offering, namely writing and performing quality review of Patient Safety Narratives for Clinical Study Reports, is a result of our relentless commitment to Oviya MedSafe’s core value of continuous capability-building coupled with the organization’s experience-based learning derived by working with multiple global clients since 2012.
As many of you would know, Patient Safety Narratives are comprehensive and clinically relevant chronological summaries of adverse events experienced by clinical trial subjects during or immediately following the clinical study in question. With Patient Safety Narratives playing a vital role in Clinical Study Reporting, it is of utmost importance that the narratives are written in compliance with the applicable regulatory requirements, for all phases of clinical studies, regardless of whether the subjects involved are healthy volunteers or patients suffering from a disease / condition that is being studied
According to Section 12.3.2 of the ICH E3 Guideline (Structure & Content of Clinical Study Reports), brief narratives describing each death, each other serious adverse event, and those of the other significant adverse events that are judged to be of special interest because of clinical importance, need to be written. Events that are clearly unrelated to the test drug / investigational product may be omitted or described very briefly. The section further explains what a Patient Safety Narrative is expected to describe and what additional information should be included in the description.
Whilst we are on the topic of narratives, it is appropriate for me to emphasize that Oviya MedSafe would conduct a post-conference workshop titled ‘Case Narrative Writing for Reporting Adverse Events’, at the 6th Annual Pharmacovigilance Asia 2015 conference organized by IQPC in November at Singapore, in which the focus areas would be Patient Safety Narratives for Clinical Study Reports and Case Narratives for Individual Case Safety Reports. I take pleasure in inviting you to join us for this conference at Singapore, in which I shall also deliver a lecture on ‘Exploiting Social Media to Identify Potential Safety Signals and to Augment Adverse Event Data Collection’ and participate in a panel discussion titled ‘Overcoming Challenges in PV in Developing Asia’. Please click here to download the agenda of this conference.
Prior to the Singapore visit, I would travel to the UK in October to chair EasyB’s UK Pharmacovigilance Day 2015 conference which is to be held at London. I am delighted to share with you that the conference agenda is shaping up very well and the registrations are quite encouraging so far. My Co-Chair Dr Sumit Munjal, Medical Director Lead, Global Pharmacovigilance at Takeda Pharmaceuticals, UK and I are glad to invite you to be part of this interesting gathering which intends to take a closer look at unique areas in pharmacovigilance that are not often discussed in other events. During the same trip, I plan to attend the 10th Annual Conference of the Pharmaceutical Information & Pharmacovigilance Association (PIPA), UK too, where I hope to meet many of you.
Moving on to Indian pharmacovigilance, I wanted to inform you that our webinar titled ‘Why pharmaceutical companies are in a dire need of building an innovative and efficient pharmacovigilance system for Indian compliance‘ announced in Oviya MedSafe’s July 2015 newsletter has been postponed to a later date, due to lots of happening changes in the Indian drug regulatory system, which made us decide that holding the webinar after the regulations get crystallized would make it more unambiguous and engaging to the stakeholders.
On another note, with India being a preferred pharmacovigilance outsourcing destination today, it is obvious that the time has come for the world’s second most populous country to realize its ambition of playing a key competitive role in the global pharmacovigilance scenario. Recognizing this emerging evolution, the 2nd National Pharmacovigilance Symposium of the Indian Society for Clinical Research (ISCR), rightly titled “Leveraging India’s Potential for the Advancement of Global Drug Safety”, has been organized at Bengaluru, India on Friday 25-Sep-2015, to which I invite you, in my personal capacity as the Chair of ISCR’s Pharmacovigilance Council, to participate in the day’s proceedings and also, if possible, to patronize this milestone event by sponsoring it.
Last but not the least; I wish to let you know that we at Oviya MedSafe are looking for mid and senior level medically qualified pharmacovigilance professionals experienced in outsourced drug safety operations to join our team atour global delivery centre in Coimbatore and be part of Oviya MedSafe’s growth. If these criteria are applicable to you and if you are interested, please e-mail your CV with a covering letter to careers@oviyamedsafe.com so that our HR team could connect with you.
Thanking you for the patient read and looking forward to writing to you again in end September 2015,
With thanks & regards,
Dr J Vijay Venkatraman
MBBS, F. Diab., MBA, FPIPA (UK)
Managing Director & CEO,
Oviya MedSafe Pvt Ltd,
Coimbatore, India
Phone: +91-422-2444442
Director,
Oviya MedSafe UK Ltd,
London, UK
Phone: +44-8452-733839
Web: www.oviyamedsafe.com
Mail: info@oviyamedsafe.com
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