Industry-government connections forged at first regulatory affairs seminar
Thursday, Sept. 28, 2017
Participants discuss global approvals, data quality, supply chain interruptions and bioequivalence in the regulatory process of animal drug development. | Download this photo.
OLATHE — On Sept. 21, 130 professionals from animal health companies across the U.S. met at the Kansas State University Olathe campus to discuss the challenges and opportunities in the current regulatory process with the federal officials who oversee the nation's practices.
"The Future Vision of FDA's Center for Veterinary Medicine: Opportunities and Challenges in the Regulatory Process" connected the region's animal health industry to the Food and Drug Administration's Center for Veterinary Medicine. The goal was to expand the dialog between the entire animal health industry and the center in order to identify opportunities that improve the regulatory process so that safe and effective animal drugs could reach the market in a predictable and timely manner.
Attendees participated in roundtable discussions to brainstorm how both industry and the center could improve. Groups focused on global approvals, data quality, supply chain interruptions and bioequivalence. Groups discussed the challenges that exist in each topic when it comes to drug discovery in the animal health arena and identified opportunities and potential solutions for these challenges.
"Today was just scratching the surface of getting the Center for Veterinary Medicine closer connected to the industry," said Robert Casillas, vice president of strategic global health security at MRI Global. "It's been beneficial meeting with leaders who influence how products get to the consumer market and sharing how we can better serve one-another."
"The interaction that I've seen here today has broadened my perspective tremendously," said Todd Rhodes, manager of regulatory affairs at Bayer Animal Health. "Bringing people together from all aspects of the regulatory process has been both enlightening and appreciated."
Steve Solomon, director of the Food and Drug Administration's Center for Veterinary Medicine, also shared his vision for the organization. He spoke about the center's key initiatives and current approaches in the animal drug approval process.
Solomon also addressed some of the challenges the center faces. These include animal drugs for minor species, as well as unmet animal health needs for major species; international harmonization; antimicrobial resistance; and post-market safety and quality.
Solomon's message to seminar attendees was clear: The Food and Drug Administration's Center for Veterinary Medicine wants to explore different opportunities and venues to interact with the entire animal health industry.
"We're interested in your input," Solomon said to the audience. "We want to talk about the regulatory process, the challenges with it and how we can make sure that innovative products continue to be developed."
Solomon and colleagues will use feedback collected during the roundtables to help enhance the center's work. Additionally, the center is looking for leadership in the industry community to work on opportunities and challenges identified for the animal health industry.
This seminar is the first in a series of four that will be offered throughout the academic year. The series is designed to provide hot topic information in regulatory affairs.
The next seminars are "Regulatory Challenges Associated with New Technology Implementation" on Dec. 7; " Impacts and Lessons Learned from the Veterinary Feed Directive" on March 8, 2018; and " Compliance and Auditing: Is your Company Prepared?" on June 7.
More information and registration for the upcoming seminars will be announced in the future.