Posted 07 September 2016
By Mary Meagher
Over the past 40 years, RAPS has sought to elevate the regulatory profession through education, certification and the sharing of knowledge. While RAPS members will celebrate this drive toward regulatory excellence in San Jose at the 2016 Regulatory Convergence, the regulatory environment continues to evolve.
As RAPS develops the offerings that will meet the future needs of the regulatory profession, it is hearing every day from members about the rapid pace of technological innovation, heightened global safety issues, different and changing regulatory environments—just a few of the changes and challenges that continuously influence the regulatory landscape.
“Innovation is taking place at such a rapid pace that there is a real challenge in how we apply what we understand to be the expectations regulators may have for these new technologies,” said RAPS board member Glenn Byrd. “As regulatory professionals, we have a role in identifying potential solutions and producing a well-thought-out plan that will address the real regulatory issues an agency may have when a new technology is introduced.”
Shaalini Doan, head of the RAPS San Francisco Bay Area Chapter agreed. “Innovation will be a regulatory challenge,” said Doan. “For example, when one starts to cross the line between drugs and medical devices, then requirements are different. And when medical devices communicate with smart phones, the challenge is understanding the impact of that technology, and translating the regulatory requirements so a company may successfully launch their product.”
“If you look at the technology available today, it shows the diversity and complexity of products, and how complicated they are becoming,” added Don Boyer, strategy lead on RAPS board of directors. “The training that regulatory professionals will require in order to adapt themselves to this changing regulatory environment is going to be phenomenal.”
Boyer also pointed to an increasingly global marketplace for regulated products as another factor that will require ongoing training for regulatory professionals. “This presents a significant challenge for the regulatory professional because there is a proliferation of regulatory frameworks, even if many have common elements,” said Boyer. “It requires regulatory professionals to be well trained on what the requirements and nuances are between various regulatory systems in order to seek market approval in those jurisdictions.”
“Globalization impacts the role of the regulatory professional,” said RAPS member Anjali Atal-Gupta. “In addition to learning global regulations, you also must be aware of different ways to interact with multiple global agencies. For example, certain cultures may have a different question-and-answering technique than we may have in the US, EU or Canada.”
“Globalization has made the regulatory profession far more complex than it has been before,” added Byrd. “To understand how to get a product approved in China versus the US versus Europe or other countries, takes very different skill sets. It has caused the profession to really specialize in some areas—some by geography. This will continue to help grow the profession.”
Within this dynamic environment, RAPS is working to adapt its regulatory professional offerings to meet not only the current but also the developing future needs of the profession. Building strong regulatory capabilities is about continual learning and thinking. It’s about integrating new science, technology, policy and business.
“While technology has made the globe a smaller place, one challenge remains the same” said RAPS member Meredith Brown-Tuttle. “No matter how quickly we are able to access information and reach the far corners of the world, regulatory professionals still need the tools to conduct a thoughtful analysis and develop the appropriate strategy.”
For RAPS members, “Driving Regulatory Excellence” will continue to be critical to the success of the regulatory profession and ultimately, to the public health we all work to advance.
This article is one in a series looking at the development of the regulatory profession and of RAPS during RAPS’ 40-year history. This year marks the organization’s 40th anniversary, which will be celebrated during the Regulatory Convergence, 17–20 September in San Jose. For more information or to register, visit RAPS.org/Convergence.
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