I am pleased to meet you all through the September 2013 edition of Oviya MedSafe's newsletter, with the greetings of the season!
On behalf of Oviya MedSafe, I am proud to announce that Oviya MedSafe has been designated the Bronze Sponsor for the 5th Pharmacovigilance Congregation 2013 organized by Virtue Insight on November 20, 2013 at Kohinoor Continental Hotel, Mumbai, India!
With the theme of the congregation being “Ensuring safer drugs to market by analyzing latest developments in pharmacovigilance, drug safety and risk management", I am sure it is most appropriate for Oviya MedSafe to partner with Virtue Insight as one of the key sponsors of the event. I am keen to meet many colleagues from the industry at the congregation and also invite you to be part of the professional gathering. I hope to share more information about this event in our next month's newsletter.
I am happy to emphasize on Oviya MedSafe's featured service of the month - the preparation of Pharmacovigilance System Master File (PSMF), which is an integral part of our service portfolio.
The PSMF is a legal requirement in the European Union. The PSMF shall describe the pharmacovigilance system and support / document its compliance with the requirements. Apart from fulfilling the requirements for a PSMF laid down in the legislation and guidance, it shall also contribute to the appropriate planning and conduct of audits by the applicant or marketing authorizations holder(s), the fulfillment of supervisory responsibilities of the Qualified Person for Pharmaco Vigilance (QPPV), and of inspections or other verification of compliance by national competent authorities.
The PSMF provides an overview of the pharmacovigilance system, which may be requested and assessed by national competent authorities during marketing authorization application(s) or post-authorization.
Looking forward to meeting you with more interesting news in October 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