I am immensely happy to reach out to you through the April 2013 edition of Oviya MedSafe's newsletter. Oviya MedSafe was launched at a stellar event at Coimbatore on 23-Feb-2013, about which you would have read in our previous edition. March 14th 2013 was special to us as we celebrated the first anniversary of the founding of our brand 'Oviya MedSafe'. It was a moment of pride for our management and staff to recollect our steady growth from being just a concept with a logo in March 2012 to a full-fledged pharmacovigilance consulting & services company with international clients and a robust operational team with experienced leaders at the helm of affairs, in March 2013.
Oviya MedSafe had its first experience as an exhibitor in the 4th Pharmacovigilance Conference of the Drug Information Association at Bangalore on March 8th & 9th 2013. We had a good number of visitors to our stall who were keen to know about our pharmacovigilance services. Our corporate presentation on Oviya MedSafe's capabilities in pharmacovigilance is attached with this letter.
Oviya MedSafe's event partnership with IQPC Singapore continues for the second consecutive year for the 4th Annual Pharmacovigilance Asia 2013 which is to be held between 18th and 21st June 2013. We take pleasure in inviting you to this conference on behalf of the organizers and firmly believe that it will provide a 360-degree perspective of the pharmacovigilance activities with respect to the Asian continent. Please do write to us for more information on this event.
At this juncture, I am also glad to share with you that I have been asked to author a 2-part series on Pharmacovigilance for publication in the popular pharma magazine Pharma Bio World. The first article on Indian Pharmacovigilance has already been published in the March 2013 edition which is in circulation now. The second article titled 'Pharmacovigilance Outsourcing and Career Advantages for Indian Professionals' will be published in the April 2013 edition. I would be glad if you could read the articles and provide your valuable feedback. I will share the PDFs of the articles with you once they are e-published.
On the projects' front, Oviya MedSafe is approaching the completion of a signal detection support project from a European client and will start working on managing the Individual Case Safety Reports (ICSRs) of another client from Europe shortly. We have also started to work with a couple of pharmaceutical companies in various parts of the world on consulting projects. Before concluding this letter, I am pleased to place on record that we have an in-house team with expertise and experience in writing Risk Management Plans (RMPs) as well as Risk Evaluation and Mitigation Strategies (REMS), which is our featured service for this April 2013 edition of our newsletter.
Risk Management Planning - What, Why & When?
In many countries, distinct drug safety plans are required as part of a medicine’s approval process and to retain its approved status. These plans are mandated by:
• ICH Harmonized Tripartite Guideline - Pharmacovigilance Planning - E2E
• Guideline on Good Pharmacovigilance Practices (GPvP) Module V – Risk Management Systems
• The U.S. Food and Drug Administration Amendments Act (FDAAA) and the FDA’s Guidance for Industry Format and Content for Risk Evaluation and Mitigation Strategies (REMS), REMS Assessments, and Proposed REMS Modifications
Recognizing even prior to the enactment of such legislation and regulations that clinical studies do not necessarily represent real-world experience, pharmaceutical companies often designed Risk Management Plans in the pre-approval stages of developing new medicines and included them in submissions for approval.
This type of a plan, or system, may be defined as a set of pharmacovigilance activities designed to identify, characterize, prevent, or minimize risks related to the medicine; to assess the effectiveness of those interventions; and to communicate those risks to patients and health care providers. In Europe, Risk Management Plans (RMPs) are now routinely required by the European Medicines Agency as part of the medicine approval process.
A Risk Evaluation and Mitigation Strategy (REMS) is developed to help ensure that the benefits of a medicine outweigh its risks. REMS may be required by the FDA as part of the approval process for a new product, or for an approved product when new safety information emerges. An applicant may also voluntarily submit REMS.
Oviya MedSafe is capable of providing all services covering the entire life cycle of Risk Management Planning. We are keen to work with you on your RMPs and would be delighted to answer any questions that you may have in this regard.
Looking forward to meeting you through our May 2013 newsletter,
With thanks & regards,
Dr J Vijay Venkatraman
MBBS, F. Diab., MBA
Managing Director & CEO,
Oviya MedSafe Pvt. Ltd.
Pharmacovigilance Consulting & Services