Few Pharmas Expect to Meet EVMPD Deadline Virtify survey reveals only 15% of big pharma, 35% mid-size pharma are optimistic about submitting all required data in time
CAMBRIDGE, Mass., Feb. 13, 2012 /PRNewswire/ -- Polling conducted by Virtify, Inc. revealed that most pharmaceutical companies are concerned about their ability to comply with the requirement to submit additional pharmacovigilance data to the EMA EudraVigilance Medicinal Product Dictionary (EVMPD) in advance of the July 2, 2012 deadline.
Attendees from 50 different pharmaceutical companies were polled during a Virtify sponsored roundtable about the likelihood that their company would meet the EVMPD deadline, given current guidance. Of the thirteen top 20 pharmaceutical companies represented, only two thought they would definitely or likely meet the deadline. 38% thought it was unlikely they would meet the deadline and over 30% thought their company definitely would not meet the deadline.
Mid-size pharmas were more optimistic, with over 35% expecting to make the deadline. 50% thought that they probably or definitely would not make the deadline, however. About half of all companies were looking to third-party solutions or technology vendors to help them achieve compliance. "We have heard from many companies that the mandate is a challenging new requirement in a very tight timeframe," said Satish Tadikonda, CEO and founder of Virtify. "These data show just how challenging it is. On the other hand, 82% of the companies thought they would definitely or probably meet the July 2 deadline if the requirement to include structured substance information was dropped."
Full survey results can be found at http://www.virtify.com/news-events/events/virtual-evmpd-roundtable-on-addressing-the-ema-evmpd-mandate-insights-from-pharmaceutical-company-executives-vw/evmpd-roundtable-survey-results/
Virtify is the market leader in Structured Content Management solutions for life sciences. Virtify solutions help reduce time-to-market, risk, and costs by managing and automating the complex regulatory compliance and content exchange requirements throughout the product life cycle. Virtify's easy-to-use software suite provides a secure, collaborative, web-based environment for managing regulated content throughout the entire continuum – from pre-clinical through product registration to commercialization.
Virtify EVMPD helps customers collect, validate, and manage the required EVMPD data, submit the data electronically to the EMA and efficiently provide updates on product data when product information is changed. It is part of the Virtify suite of structured content management based solutions which ensures that all data gathered is optimized for re-use across the organization.www.virtify.com
SOURCE Virtify, Inc.