Drug product labeling is continuing to grow both in complexity and strategic importance as the key document for communication of benefit: risk to health care professionals and patients. Life science companies not only have to ensure harmony of messaging from Core Data Sheet to Local Prescribing Information, but also track and document the implementation of labeling changes and any local variations. In addition, there is increasing pressure by Health Authorities to demonstrate overall performance, quality and compliance of the end-to-end labeling process.
To address these challenges, a unified global labeling continuum that coordinates upstream (i.e. signal detection) and downstream (i.e. the printing and distribution of the label) activities requires an integrated services, process and technology model. This webinar will focus on translating current business drivers and challenges within the global drug product labeling domain into a set of opportunities and next-generation operating models that support scale, efficiency, quality and compliance.
Viewers will learn:
- What is driving labeling complexity in terms of internal pressures, such as global expansion and evolving global health authority expectations
- What the future looks like with regards to the seamless integration of the end-to-end labeling process (from signal to package) coupled with external services and technology enablers
- How to assess the overall performance and quality of the labeling process
Bindu Narang, Director of Scientific Writing and Regulatory Affairs, Sciformix
Bindu Narang oversees Sciformix’s scientific writing and regulatory affairs practice. She is a seasoned Pharmaceutical professional, and has over 25 years of experience working both with Pharmaceutical companies and CROs. Bindu has set-up and worked closely with publishing groups using eCTD submission tools and software. Prior to Sciformix Bindu headed up the Mumbai regulatory writing group for Pfizer where she helped established a matrix regulatory writing organization. Bindu holds a Masters degree in Pharmaceutical Sciences (Medicinal Chemistry). Bindu presents at conferences and organizations around the world on medical writing, global labeling management and document reviews.
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. Currently, Craig serves 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
From pharmaceutical, biotechnology, medical device companies and contract research organizations (CROs) worldwide
Sciformix Corporation collaborates 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
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