- Victoria Millward
|Program||:||Clinical Trials, Regulatory Affairs|
Victoria Millward had been working as lab bench scientist and quality control supervisor for a few years when she decided to shift gears and pursue a certificate in Clinical Trials and Management at UCSC Extension in early 2010.
“I knew that it was going to be a career path change,” she says. “I was working at a device company at the time that didn’t do a lot of clinical trials; they did mostly comparison studies and in vitro diagnostic tests. I wanted to learn more about direct human trials.”
Millward had just moved back to California after a brief stint on the East Coast and was excited to find an entry-level position managing clinical trials for skin care products at a small cosmetics company in San Francisco. She was grateful that her Extension courses mirrored her new responsibilities on the job, and was soon relying on her instructors and peers to help her acquire the skills she needed in clinical trials.
“When I was just starting in this industry, everything was a challenge. It was a huge learning curve. [I saw that] by taking each course one at a time, and learning different parts of clinical trials and their regulatory aspects, it helped me overcome that hurdle.”
After completing her Clinical Trials certificate, she reviewed her transcript and current offerings to see how many requirements she would need to fulfill the Regulatory Affairs certificate. She observed a significant overlap between the two fields.
“A lot of things I learned in the classes I could directly use as my work progressed. Everything about good clinical practices was so important, as was reading about regulations. [I learned] what’s expected from the sponsor or investigator and the rights of humans in trials. The clinical monitoring course taught me the best way to monitor a subject and make sure that you have good data in compliance with your protocol. It comes full circle—as you progress in your career, you might not want to be a clinical monitor, so it [is helpful to] move into regulatory affairs by writing and reviewing things you are going to submit. There are a lot of parts to clinical operations that border on regulatory affairs.”
Millward senses that the future of regulatory affairs and clinical trials will rely on industry professionals who stay current with changes in regulations, research and drugs. After she completed both Extension certificates, she went on to pass the RAPS exam, certifying her as a regulatory affairs professional. She has also passed the necessary exams to become a clinical research associate (CRA) and has a few years to fulfill certain educational requirements to maintain her certification.
“It’s a never-ending process,” she says. “UCSC Extension offers courses that apply to recertification, plus it gets you to network with other people in the industry and to hear about new FDA regulations. It keeps you abreast with the information that’s out there.”
These days, Millward is qualified to perform multiple tasks at her company; she works in quality systems, manages all post-marketing adverse events, and manages all clinical trials for skin care products.
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