February 2021

A Korean Scientific Reviewer’s Year of Training at a U.S. CRO - Part 2

Na Ry Woo, a Scientific Reviewer at the Korean Ministry of Food and Drug Safety, reflects on the year she spent in the U.S. increasing her knowledge of U.S. FDA regulatory approval practices.

Through a special international, scientific cooperation program Mrs. Woo was hosted by Amarex Clinical Research, LLC, an NSF International company located in Germantown, Maryland. Amarex is a global, full-service contract research organization (CRO) that helps biotech, pharma, medical device, diagnostic and vaccine companies obtain U.S. FDA (and international) marketing approval of their new medical products.

Amarex is a global, full-service contract research organization (CRO) that helps biotech, pharma, medical device, diagnostic and vaccine companies obtain U.S. FDA (and international) marketing approval of their new medical products.

Na Ry and her family arrived in the U.S in November 2019 and departed mid-October 2020. She shared her experience with Patrick Burke, Senior Director of Business Development at Amarex, shortly before departing for home in Korea.

Patrick: Tell me about your year working at Amarex.

Na Ry: For one year, I worked with the Regulatory Affairs team on Investigational New Drug (IND) submissions, including preparing, reviewing and processing regulatory documents. I learned a lot about Amarex’s system for submitting applications to the FDA. This was a new and valuable learning experience for me.

Patrick: How do you believe your experience at Amarex will impact your position as a scientific reviewer at the Korean MFDS?

Na Ry: I’m sure that it will be very helpful in my future work at the MFDS as a reviewer. In the process of preparing regulatory documents according to Common Technical Document (CTD) standards, I can deeply understand each module. With these skills I will be able to better request resources for the Korean MFDS.

Patrick: What were some of the difficulties of adjusting to life in the U.S. and working at Amarex?

Na Ry: There were no major difficulties adjusting to life in the U.S., but I would have liked to communicate and interact with people more. The language barrier and my quiet personality meant that I couldn’t socialize as much as I would have liked. This was further limited due to COVID-19 restrictions.

Patrick: What were some of your enjoyable experiences living in the U.S. and working at Amarex?

Na Ry: At Amarex, I attended the company’s holiday 2019 party with my family. My kids, husband and I all enjoyed that experience getting to know Amarex colleagues and meeting their families. I also traveled around the U.S. and saw Niagara Falls and the Grand Canyon National Park. I found many great sightseeing spots that were completely new to me. The U.S. is so beautiful.

Patrick: What advice would you give another MFDS staffer about training abroad?

Na Ry: I would suggest that they learn as much as possible while in the training program, and I would specify that it’s important to jump right into the work. Having an active and positive attitude is also very helpful for training abroad.

Patrick: What did your husband and children think about their experience?

Na Ry: My family is very thankful for this opportunity. As expected, living in another country makes the world much wider. One of my daughters said that when she grows up, she wants to be an animator at Disney. This decision may change, and the culture will be different when that time comes, but it was a great experience for her to experience another culture at such a young age.

Patrick: What were some things that you learned about American culture that were new or surprising?

Na Ry: The best part of American culture that I experienced was its respect for diversity. Many people from different races, with varied circumstances and different ideas, are all living together here. I’m sure this level of diversity increases creativity and development in American society.

Patrick: Did you establish relationships with persons here in the U.S. that you expect to maintain?

Na Ry: Over the last year, I made friendships with a lot of good people in my neighborhood and at Amarex. I hope to stay connected with these friends after I return to Korea. I would be grateful for the chance to host one of my new friends during a visit to Korea.

Patrick: Would you do another year-long training in the U.S. if you got the opportunity?

Na Ry: Absolutely. The experience was great and there is much more I can learn from spending another year in the U.S.

Patrick: What are you and your family looking forward to on your return to Korea?

Na Ry: We plan to go to our favorite restaurant, and we are very excited to see our family and friends again. I’m also looking forward to seeing my friendly colleagues at MFDS.

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