RAPS Founder Richard E. Greco died last week near his home outside of Buffalo, NY. He was 87 years old. During his career, he served as vice president for regulatory affairs with Life Technologies and president of Regulatory Associates Inc. He has been honored by the US Food and Drug Administration (FDA) with the Commissioner’s Special Citation, and in 1979, he become the inaugural honoree of the eponymous Richard E. Greco Award from RAPS.
Greco founded RAPS in 1976. At that time, regulatory affairs was not recognized as a profession, but merely a collection of tasks. Greco saw the need for a profession dedicated to ensuring compliance with relevant pharmaceutical or medical device regulations. “No longer was it possible, or acceptable, to have the least busy person in a company handle regulatory affairs and the FDA investigator, who was coming in to conduct an inspection,” he wrote in Regulatory Focus in 2000.
Greco saw the creation of dedicated regulatory departments within life sciences companies as an important first step in achieving credibility for the nascent profession. The Next step was to create an organization where regulatory professionals could learn from one another, and begin to establish dialogue with regulatory agencies like FDA, the European Medicines Agency and others, something that was lacking at the time.
“As regulatory professionals, we owe Dick Greco a great debt of gratitude,” said RAPS Executive Director Paul Brooks, “Without his leadership, the regulatory profession wouldn’t be where it is today. Over the past 40 years since he founded RAPS, the role of regulatory professionals has changed substantially. Regulatory expertise has become a business critical asset, and regulatory professionals have become strategic partners within their organizations. That all started with his vision.”
Today, regulatory professionals are involved in virtually every aspect of creating and delivering safe, effective healthcare products. They work throughout the product lifecycle, linking medicine, science and technology with regulation and business strategy.
“Dick Greco had the vision to see the importance and the potential of regulatory affairs,” said Sherry Keramidas, who served as RAPS executive director for nearly 20 years. “As the founder of RAPS, he knew this young field needed to learn and grow. He created a community among individuals working in industry and at the US FDA—that community became RAPS. Throughout his life, Dick Greco continued to share his vision and inspire generations of regulatory professionals. He always remained committed to RAPS.”