I am enthused to meet you all, through the November 2013 edition of Oviya MedSafe's newsletter, with our greetings for the season!
This month marks a milestone in Oviya MedSafe's continual growth into a full-service Pharmacovigilance Consulting Company, as we add Qualified Person for PharmacoVigilance (QPPV) Services to our consulting portfolio. I take this opportunity to share with you some information on the concept of QPPV.
In order to market medicinal products within the European Economic Area (EEA), the law requires that a Marketing Authorization Holder (MAH) must first appoint a Qualified Person for PharmacoVigilance (QPPV) who will oversee the company’s pharmacovigilance system. The QPPV is a highly qualified, highly skilled professional who fulfills a number of roles and responsibilities for the company or the MAH including:
• Establishing and maintaining the MAH's Pharmacovigilance System (including all activities which contribute to the detection, assessment, understanding and communication of safety information, as well as risk management activities);
• Overseeing the safety profiles of the company’s marketed products and addressing any emerging safety concerns;
• Acting as a single point of contact for the regulatory authorities on a 24-hour basis and being the contact point for pharmacovigilance inspections.
The QPPV must be “permanently and continuously at the disposal” of the MAH and must be experienced in all aspects of Pharmacovigilance. This is often a challenge for small to medium-sized companies, as the Qualified Person for PharmacoVigilance must reside within the EEA, and a deputy may be needed as well. Often, companies which are emerging in Europe either do not have the infrastructure locally, or do not have the access to an appropriate individual.
Oviya MedSafe is now capable of providing QPPV services for clients entering into the European Union (EU) market to ensure appropriate management of the MAH’s pharmacovigilance systems in the EU.
Personally, I am happy that I will be spending almost the whole of the next week (3rd week of November 2013) in Mumbai to meet various clients and potential clients of Oviya MedSafe. It will be my pleasure to catch up with you too, if you are available in Mumbai during that period.
As you might already know, the core reason for my Mumbai visit is Oviya MedSafe's participation as a Bronze Sponsor in the 5th Pharmacovigilance Congregation 2013 organized by Virtue Insight on November 20, 2013 at Kohinoor Continental Hotel, Mumbai. Along with Virtue Insight, Oviya MedSafe cordially invites you to register for the event and, of course, visit Oviya MedSafe's Bronze Sponsor stall at the venue, where we can catch up for quick interactions.
Looking forward to meeting you at Mumbai next week and reaching out to you with more news in December 2013,
With thanks & regards,
Dr J Vijay Venkatraman
MBBS, F. Diab., MBA
Managing Director & CEO,
Oviya MedSafe Pvt. Ltd.
Pharmacovigilance Consulting & Services
2nd Floor, KTVR Gardens,
220a-3, Marudha Konar Road,
Coimbatore - 641 025.
Tamil Nadu, India.
Office Mobile: +91-94422-25311
Office Phone: +91-422-2444442