Value Vigilance: A Transformative Approach to Managing Safety and Regulatory for Established Products

Drug Safety, Life Sciences, Pharmaceutical, Pharmaceutical Regulation ,
  • April 02, 2015

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

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.

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.

Come out of this webinar with 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. You will learn 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

Speakers

Matthew McKeever, M.D., FAAP, VP and Global Head, Safety Knowledge and Reporting, Medical Safety, Aggregate Reporting, Benefit Risk Management and Regulatory Reporting, Quintiles

Matthew McKeever, M.D., FAAP, is VP and Global Head, Safety Knowledge and Reporting, overseeing Quintiles’ Medical Safety, Aggregate Reporting, Benefit Risk Management and Regulatory Reporting teams, and has been with Quintiles since October 2000. He graduated from Cornell University Medical College in New York and completed residency in Pediatrics at Northwestern University affiliate Children’s Memorial Hospital in Chicago, Illinois. Dr. McKeever practiced academic primary care pediatrics at the Children’s National Medical Center during which time he held the appointment of Assistant Professor of Pediatrics at the George Washington School of Medicine.

Dr. McKeever has extensive experience in Late Phase studies including large disease and product surveillance registries and Phase IV trials, and in clinical development Phases II-IIIb in the areas of cardiovascular, CNS, and respiratory as both a medical advisor and later in his role of Global Head for Internal Medicine. He also has experience in the Phase I development area having led the Quintiles Phase I Research Unit at Guy’s Hospital in London from 2010 through 2013. He is board certified in Pediatrics, and a Fellow of the American Academy of Pediatrics.

James C. Walker, CEO and Founder, Octagon Research Solutions, Inc.

James C. Walker is the founder of Octagon Research Solutions, Inc. and has been working in the Pharmaceutical industry for 20 years. Prior to founding Octagon, he worked as the Senior Manager of Worldwide Regulatory Affairs for the Schering-Plough Corporation (“Schering”). While at Schering, he was responsible for clinical and pre-clinical in the antihistamine, central nervous system, and critical care therapeutic areas.

Prior to joining Schering, Mr. Walker worked across multiple therapeutic areas in the Regulatory Affairs/Clinical and Clinical Quality Assurance department at the R.W. Johnson Pharmaceutical Research Institute (PRI). Mr. Walker has extensive experience in and knowledge of all phases of clinical research and both FDA and European regulations. He is skilled at process improvement and providing insight across multiple disciplines within drug development.

Mr. Walker holds a B.S. in Biological Sciences from Villanova University, a Masters in Environmental Sciences from Rutgers University, and an M.B.A. from Duke University.

Who Should Attend?

Senior level executives working in:

  • Clinical Development & Clinical Operations
  • Pharmacovigilance & Drug Safety
  • Regulatory Affairs
  • Medical affairs
  • Data Management
  • Commercial Operations
  • Market Access

The presentation will benefit large and mid-size biopharmaceutical companies seeking to redirect in-house resources at a lower cost, as well as mid-size pharma companies with new global products in search of external capabilities to manage maintenance activities.

Xtalks Partners

Quintiles

Quintiles (NYSE: Q), a Fortune 500 company, is the world’s largest provider of bioPharmaceutical development and commercial outsourcing services. With a network of more than 32,000 employees conducting business in more than 100 countries, we helped develop or commercialize all of 2013’s Top 100 best-selling drugs on the market. Quintiles applies the breadth and depth of our service offerings along with extensive therapeutic, scientific and analytics expertise to help our customers navigate an increasingly complex healthcare environment as they seek to improve efficiency and effectiveness in the delivery of better healthcare outcomes. To learn more about Quintiles, please visit www.quintiles.com.

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