Product labeling teams are accountable for driving both timely and accurate benefit: risk communications and ensuring demonstrable process performance. To do this, they must be adept at providing a critical link between upstream information providers (e.g. clinical development, pharmacovigilance) and downstream implementers (e.g. manufacturing, operations). To ensure ongoing quality, compliance and competitive advantage, an optimized operating model that leverages people, processes and technology excellence has to be implemented to stay on top of evolving regulations and stakeholder expectations.
This webinar will focus on the evolution (past, present and future) of labeling for innovative and generic drug companies. Our distinguished panel of labeling experts will provide real-life examples and evaluation of current models and trends, along with best practices for managing product labeling activities through the seamless integration of all stakeholders with clear roles and responsibilities, efficient and effective processes and technology enablers.
Attendees will learn:
- How the role of Global Labeling has evolved and the importance it has in the entire organization.
- How internal and external trends require teams to continually evolve and grow.
- What the future looks like with regards to current best practices and how integration of an end-to-end labeling process (from signal to package), coupled with external services and technology enablers plays a critical role.
Beth A. Lage, RAC, Associate Director of Strategic Global Labeling for Medical Products, Baxter Healthcare Corporation
Beth is an Associate Director of Strategic Global Labeling for Medical Products, Baxter Healthcare Corporation. She has broad experience in content development and management of Company Core Data Sheets (CCDS) and Pharmaceutical labeling. She provides expertise in formulating global regulatory labeling strategy, assessing impact of labeling regulations, and global labeling implementation management, tracking and workflow.
She holds a B.S. in Medicine, and a B.S. in Biology from the University of Iowa. She is a board certified Medical Technologist and has a Regulatory Affairs Certification (RAC). Beth is currently pursuing her MBA from Lake Forest Graduate School of Management.
Griha L. Mangru, Labeling Strategist, Global Labeling Management Team, Pfizer
Griha joined Pfizer in 2009 as a Regulatory Strategist, supporting in licensed generics. She is currently a Labeling Strategist, on the Global Labeling Management Team. Prior to joining Pfizer, Griha held Regulatory and Quality positions at Sandoz, Eon Labs and Estee Lauder. She holds a Bachelors in Chemistry from the State University of New York (SUNY) at Stony Brook, and a Masters in Pharmaceutical Marketing and Health Care Administration from Long Island University.
Boris Jankowski, Director of Solutions Architecture, Sciformix
Boris joined Sciformix Corporation in January 2014 as Director and Global Head, Solution Architecture Services. In his role, Boris is responsible for the corporate solutions offering strategy, development and evolution, including Global Labeling. Boris and his team engage directly with existing and prospective clients for the design of end-to-end solutions and alternative operating models within the Regulatory Affairs, Pharmacovigilance and Clinical Development domains. Boris joined Sciformix from Amgen where he supported the RA and PV organizations in various functional and leadership roles within Global Labeling, Benefit: Risk Communications, Operational Excellence and External Strategy functions. Prior to Amgen, Boris spent time as a scientist working within industry and academia with a focus on analytical chemistry, protein-biochemistry and metabolomics. Boris holds an M.S in Chemistry from the California State University, Fullerton and an M.B.A. from Pepperdine University.
Craig Trautman, CEO, Intagras
As the CEO of Intagras, Craig’s primary responsibility is driving the strategic initiatives, plans and policies established by the Intagras Board of Directors while overseeing the client-centric approach to sales, service and support that are the company’s hallmarks. His day-to-day activities consist of a varying slate of priorities, including managing business development, determining organizational direction, making key project decisions, interacting with human resources, and accounting. Craig has served as a member of the SPL Leadership team and is also a member of the technical, process, and generic sub-teams.
Who Should Attend?
VPs, Department Heads, Directors and Managers involved in:
- Drug Labeling
- Medical Device Labeling
- Regulatory Affairs
Sciformix Corporation collaborates with life science organizations through the entire product development lifecycle to provide a full-range of services from pre- to post-marketing support. Our labeling managed services comprises people expertise, streamlined processes and technology that helps clients achieve quality, compliance and efficiency. Visit us on the web at www.sciformix.com and www.sciformix.com/labeling.