Posted 22 August 2016
By Mary Meahger
When the regulatory profession convenes for the 2016 Regulatory Convergence in San Jose next month, it will be an occasion for members from both government and industry to build on their working relationships, to discuss with one another new guidelines and compliance issues and, generally, to bridge their understanding about regulatory matters unique to those who work in different facets of the profession.
“These are working opportunities I never had early on in my career,” said Don Boyer, a former regulator with Health Canada and current RAPS board member. Boyer points to sessions he leads at the Convergence aimed at how to interact effectively with regulatory authorities. “We identify and bring together panels of current and former regulators and industry experts, and set up Q&A sessions for industry representatives to ask advice on how to conduct a meeting, phone conversation or email to get the most out of that interaction with the regulator.”
Productive and collegial collaboration between regulators and their industry counterparts, historically, was not always the case. Virginia Perry is the founding member of the RAPS Bay Area Chapter. She recalls how rigorous FDA’s Pacific Region office was in its compliance in the early 90s, issuing many Warning Letters and 483s to industry. “For two years, our chapter activities were very focused on industry compliance, educating our people to understand the new quality system regulations,” said Perry. “It was important that we partnered with FDA to develop relevant trainings. That was the beginning of our relationship with FDA here.”
Bay Area RAPS member Kiran Gulati added, “The relationship today is a lot more collaborative. There is more transparency on the part of the regulators, especially with the issuance of guidance documents in both the US and the EU. If there are questions, regulatory professionals are able to have that open conversation, ask questions of regulators so they are on the right track.”
“Globally, I think the relationship between regulators and the industry has improved tremendously,” said Jude Nwokike, director, Promoting the Quality of Medicines (PQM) program of the United States Pharmacopeial Convention (USP) and member of RAPS. “It has improved because of the opportunities that stringent regulatory authorities, like the US FDA have created.”
“The relationship today is a really professional one of mutual respect,” says Glenn Byrd, RAPS board member and former FDA official. “Regulators value the partnership that those in industry are able to develop with them in order to address public health issues.”
Byrd continued, “Regulators appreciate when the industry professional brings strong expertise to the table. The regulators provide a framework in which to operate, but industry has to be smart about how we think through regulatory solutions. When you present an answer, and you back it up with science and data, agencies such as FDA appreciate that.”
Former FDA regulator and RAPS member Mark Paxton says the integrity of the agency-industry relationship is of primary importance. “This is especially evident in more developed countries where the burden is on industry to do the right thing,” said Paxton. “Industry needs to be responsive to questions raised by regulators. When you are responsive, it builds trust and the issue identified by the regulatory authority can more quickly be resolved.”
The ability to readily exchange information between regulators and industry becomes increasingly critical as regulations inevitably lag behind new technologies companies are developing, says Bay Area consultant and RAPS member, Susan Carino. "Working closely with regulatory authorities, like FDA, in order to support a new product development strategy or rapid approval of a breakthrough product is going to be a key role for the regulatory professional going forward," predicts Carino.
Pooja Shah, education chair for the Bay Area Chapter agrees. “As we move toward the future, challenges will lie in negotiating with the regulatory agencies as we educate them about an innovative technology. I work in the new space of companion diagnostics, which is completely new to the agencies. This is where thinking out of the box comes into play.”
“As a regulator, we called those pipeline meetings,” said Boyer. “We would always encourage industry to come and make such presentations. While industry may be years away from launching a product, discussing the new technology as it developed was helpful in keeping us abreast of where the technology was headed and the challenges of regulating those products in the future.”
Byrd added, “The role that we have to play as regulatory professionals is to identify potential solutions and bring them to the regulating authority. If your company is going to introduce a new technology, produce a well-thought-out plan that addresses the concerns of the agency and include data that will help make the case.”
“This is my professional passion,” says Perry. “To find ways to get new technology approved by the regulatory agency and ultimately help a patient on the other end who will benefit from its use—that is what keep me in this business.”
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.
RAPS and the Regulatory Profession: How Far We Have Com
RAPS and the Regulatory Profession: Elevating Standards Through Education and Certification
RAPS and the Regulatory Profession: The Global Professional Network
RAPS' First Chapter Celebrates 25 Years