San Jose

The regulatory affairs role in pharmaceutical companies is rapidly changing as many of the tasks once aligned with in-house experts are being outsourced. This trend is forcing industry professionals to rethink their role within the organization and to establish themselves as thought leaders who bring measurable strategic value to the business.

This will be one of the key themes covered at the Regulatory Convergence Event, held by RAPS September 17-20. RAPS is the largest global organization for professionals involved with the regulation of healthcare and related products. This annual event is an opportunity for these professionals to explore the issues that are affecting their roles and the regulatory changes that continue to occur around the world.

One session that jumps out at me (perhaps for its clever title) is “Handling Regulatory Challenges: How to Respond with Grace under Pressure,” on Monday, Sept. 19, which offers strategies for responding to regulatory and business challenges. The session will feature a panel of regulatory thought leaders offering hands-on solutions to address everyday data regulatory scenarios. Hopefully this session will arm attendees and my fellow regulatory professionals with helpful tactics to better handle difficult situations and issues that arise when working under compressed timelines with various regulatory agencies and bodies.

There are also several sessions and workshops exploring the unique challenges and caveats of exclusivity related to orphan drug and rare disease products. The agenda for Tuesday, Sept. 20 includes two orphan drug themed sessions: an Update on Rare Disease and Orphan Drug Designations in the US, EU and Japan; and another on Latin American Regulations and Market Access for Orphan Drugs, Rare Diseases and Low Incidence Cancers. Both sessions promise to explore the unique regulatory barriers related to these treatments around the world, and how they align with market access and payer expectations. Orphan drug designations and approvals have shown impressive growth in recent years, and these sessions will offer valuable insights into the regulatory compliance issues around the world that we need to focus on as we bring these products to market.

Another interesting aspect of this year’s event is the broader look at medical devices and how they are impacted by regulatory compliance requirements. Several sessions are dedicated to the unique regulations related to medical devices in the EU, US, Japan, China and Latin America; while others explore bringing medical devices to market for small patient populations; and market access and planning for reimbursement in the medical device sector. This increasing focus on medical devices reflects the growing importance of these manufacturers in the broader biopharma industry, and the challenges that device makers face bringing their products to market.

Then of course there is my session on Integrating Safety, Regulatory and Benefit-Risk Functions: Enhanced Compliance and Efficiency in the Maintenance Phase of the Product Lifecycle, in which I will join my colleague Deirdre McCarthy, and Thomas Nesslein, director of medical safety from Abbott, to discuss best practices related to managing the safety, regulatory and benefit-risk activities for marketed product maintenance. My portion of the session will focus on innovative strategies for managing marketed products more efficiently through the use of hub and spoke models, workflow automation and other tools that eliminate much of the busy work and white space in the management process.

Many of the issues addressed in this session, and in others, will reflect the shift of regulatory affairs work to local hubs, though we will also explore new opportunities that regulatory professionals have in the current environment to work directly with regulators, provide thought-leadership advice within their respective organizations, and support product development as our profession continues to evolve. The key is to focus on where we can add strategic value to the organization, because no matter how the industry changes, regulatory thought leadership will always be a vital piece of the business process.