In the past few years I have organized a couple of small local gatherings of experienced regulatory professionals to discuss the regulatory profession, regulated industry, and regulators. The industry representation was diverse, including pharma and devices, start-ups and established companies.
To drive the discussion, I asked participants to complete some questionnaires in advance of the discussion. The sample sizes are small, but I thought people here might be interested in the results regardless.
A total of 10 people were asked to identify the responsibilities of their department.
All 10 identified regulatory strategy and submissions. The rest of the answers were varied, but consisted primarily of a range of regulatory "consulting" activities, from advising product development or clinical study teams, to assisting in due diligence for potential acquisitions, to reviewing documents.
From 16-17 people answered these questions:
How well do industry executives understand the Regulatory role and function?
Not very well = 2, Somewhat = 8, Very well = 7
How well do other departments understand Regulatory role and function?
Not very well = 1, Somewhat = 9, Very well = 7
How effective is FDA at regulating products in your industry?
On a scale of 0-4, where Not Very Effective = 0, Effective = 2, and Very Effective = 4, the average score was 2.25. No one said that FDA was Not Very Effective; one person said it was Very Effective.
How would you describe the impact of regulation on your industry?
On a scale of 0-4, where Very Harmful = 0, Neither Harmful nor Beneficial = 2, and Very Beneficial = 4, the average score was 3.00. No one said that FDA regulation was Very Harmful to their industry; four people said it was Very Beneficial.
How would you describe your industry’s response to regulation?
On a scale of 0-4, where Resistant = 0, Strict Compliance = 2, and "Meets or Exceeds" = 4, the average score was 2.38. One person thought their industry was Resistant:; three thought their industry "Meets or Exceeds."
------------------------------
Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Durham, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com------------------------------