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This comprehensive resource covers product change evaluation, postmarket surveillance, audit/inspection compliance, and various other laws and regulations pertaining to maintaining a product on the market.
Hear from leaders around the globe as they share insights about their experiences and lessons learned throughout their certification journey.
Director of Regulatory Affairs
RAC holder since 2017
My most common activities include writing/editing/reviewing protocols for chemistry, manufacturing, and control, as well as preclinical and clinical studies. For instance, in the past week I have advised on the design of a nonclinical toxicology study to support an IV product, done risk evaluation of a stability program for a Phase 1/2 product, and reviewed multiple clinical protocols.
In the past year, having the opportunity to contribute to multiple COVID-19 products in development. At one point, we completed an entire IND in 30 days.
The Regulatory Exchange (RegEx) open forum has been by far the most helpful RAPS benefit. I post and review/respond to posts regularly there. I have had many specific circumstantial questions answered, such as how to audit a database for a Phase 1 study.
Acknowledge that it will take considerable time (10 or more years) to become broadly proficient in regulatory affairs, based on the variety of exposure that comes with the profession.