SOURCE: Xtalks

Xtalks Webinars

March 19, 2015 07:05 ET

Value Vigilance: A Transformative Approach to Managing Safety and Regulatory for Established Products, New Webinar Hosted by Xtalks

TORONTO, ON--(Marketwired - March 19, 2015) - In this webinar, learn from Matt McKeever, VP and Global Head, Safety Knowledge and Reporting at Quintiles, and James Walker, founder of Octagon Research Solutions, Inc. as they introduce strategies for maximizing the value vigilance of your established product. The live broadcast takes place on Thursday, April 2, 2015 at 11am EDT / 4pm BST (UK GMT +1).

Biopharma companies' portfolios of established products have been a focus of attention in recent months amidst an increasingly complex regulatory environment; with these mounting hurdles to overcome, the challenges for maintaining and managing established products have become a costly endeavor. In parallel, anticipating compliance with the recent EU Good Pharmacovigilance Practices for benefit-risk assessments is forcing companies to rethink their traditionally compartmentalized approach to regulatory and safety functions.

As a regulatory or safety executive, your ultimate goal is to maximize revenue of your established products while reducing costs; to mitigate risk while ensuring regulatory compliance. That means you must keep a sharp eye on:

  • Increased pricing pressure - Governments and payers are scaling back reimbursement and increasing pressure to prove the value of products
  • Heightened focus on data - Regulators are demanding that companies supply both more information and greater data consistency
  • Evolving emerging market regulations - Emerging markets are rapidly increasing their expectations about regulatory documentation
  • Increased emphasis on risk assessments - Evolving regulatory requirements for marketed products, including EU GVP requirements for ongoing benefit-risk assessments

Viewers will gain insightful strategies that will enable you to create a new model that addresses the changing industry dynamics and global compliance issues, integrates global processes and improves operational efficiencies to reduce cost. Key learning points include how to:

  • Identify, manage and mitigate product risks
  • Maintain profitability later in your product's lifecycle
  • Generate greater insights into your established products portfolio
  • Contain technology and maintenance costs, and
  • Manage and staff a complex global network

The bar has been raised -- and the traditional barriers between regulatory and safety must be eliminated to ensure optimal portfolio "line of sight," and ultimately the success of your established products.

To learn more about this event visit Value Vigilance: A Transformative Approach to Managing Safety and Regulatory for Established Products

Xtalks, powered by Honeycomb Worldwide Inc., is a leading provider of educational webinars to the global Life Sciences community. Every year thousands of industry practitioners (from pharmaceutical & biotech companies, private & academic research institutions, healthcare centers, etc.) turn to Xtalks for access to quality content. Xtalks helps Life Science professionals stay current with industry developments, trends and regulations. Xtalks webinars also provide perspectives on key issues from top industry thought leaders and service providers.

To learn more about Xtalks visit
For information about hosting a webinar visit

Image Available:

Contact Information