Susan Najjar, Director of Marketing at Sciformix

3rd Annual Pharmaceutical Labeling Compliance Conference Recap

Susan Najjar

Cambridge, MA was the setting for last week’s 3rd Annual Pharmaceutical Labeling Compliance Conference hosted by Marcus Evans. Approximately 80 of the leading voices in global labeling congregated for the two day event which discussed not only the latest trends and challenges in pharmaceutical labeling, but also best practices and solutions to help manage the increasingly complex business and regulatory environment.

The major highlights of the conference included educational pre-conference workshops, expert speakers, informative panel discussions and an interactive forum to facilitate networking on the latest labeling strategies and issues directly influencing the industry. Over 25 presenters spoke on diverse issues such as workflow management and tracking, managing safety information between core and local labeling documents, streamlining communications to expedite label development, utilizing Target Product Profiles (TPPS) as a tool to establish future labeling components, tackling the challenges of labeling compliance in emerging markets and much more.

The event kicked off with Ellen Wong, Senior Manager Global Labeling Compliance, from Allergan who discussed Managing Safety Information between Core and Local Labeling Documents to Meet Global Standards for Labeling Compliance. Ellen discussed various methods for formatting and identifying safety content within the Company Core Data Sheet (CCDS) to achieve compliant labeling standards along with the management and implications of local label safety deviations.

Following Ellen’s presentation, Bindu Narang, Global Head of Regulatory Affairs and Scientific Writing, from Sciformix Corporation, presented on Next Generation Global Labeling: Achieving Operational Excellence to Ensure Compliance and Quality. Following her presentation, Bindu facilitated an expert panel discussion with Griha Mangru (Pfizer, Inc.), Deirdre Cozier (Pharma Science), Boris Jankowski (Sciformix) and Craig Trautman (Intagras). Deirdre discussed how healthcare agencies are pushing companies to be more vigilant and transparent. As a result, large international generic companies are required to submit updates more frequently, which in turn triggers more requests to update labeling documents. Since generic companies have large portfolios, these changes and requests force the companies to look at how they work, utilize resources and manage their labels in a seamless, more efficient fashion across all markets. Deirdre also discussed how updates for generic companies used to be simpler (as they would follow the reference/innovator products updates); however, the industry anticipates that the FDA will implement a new guidance that will require generic companies to revise labels independent of the innovator. Griha Mangru discussed similar yet different challenges for innovator companies. She indicated that of all the pharmacovigilance and inspection findings, 44% are labeling related. As a result, organizations need robust systems in place to ensure insight and control over labeling changes. An enhanced version of end-to-end tracking needs to be in place globally so employees have communication in a timely manner. Organizations have to consider timelines, processes, tools and solutions when it comes to keeping up with the changing labeling landscape.

Other presenters and topics included:

  • Shimon Yoshida, Senior Director Head of International Labeling Group, Pfizer presented on – The Challenges of Labeling Compliance in Emerging Markets: How to Tackle the Known Unknowns;
  • Bath Lage, Associate Director of Global Regulatory Affairs Regulatory Operations and Compliance – Labeling, Baxter presented on Global Labeling Implementation Management Tracking and Workflow; and
  • Lisa Kelsey, Regulatory Program Director, Genentech presented on Navigating and Applying the Drug Supply Chain Security Act (DSCSA) Title II of the Drug Quality and Security Act of 2013

The two-day labeling compliance summit set the stage for leaders in the industry to discuss the latest challenges and ever-growing regulatory landscape. It helped demystify the arduous global and local labeling regulations and the complex labeling lifecycle process by providing insight on:

  • Reducing medication labeling errors and enhancing safety documentation on product labels to achieve local labeling compliance
  • Identifying differences between US and EU labeling regulations to meet international labeling compliance
  • Enhancing labeling operations among cross-functional groups to assist in product labeling development
  • Identifying robust solutions to manage a product label and gain a global perspective on labeling compliance

Attendees were able to effectively engage in solution-driven discussions, the takeaways of which will surely help them develop cohesive and robust compliance strategies.