Navigating the Korean regulatory market and seeing old friends at RAPS Convergence with Joo Hee Kim
Joo Hee Kim is a pharmacy professor at Ajou University in South Korea and the managing director of the Regulatory Strategy Center for Combination Products. She joined us at RAPS Convergence 2022 for a chat about her career path, her current role and her experience at her first RAPS Convergence. This conversation has been lightly edited for clarity.
What’s your current role?
We’re government-funded. Our company is the Regulatory Strategy Center for Combination Products. Our center is funded by the MFDS, the Korean regulatory agency. Our yearly funding is $2 million per year, which is a huge amount of money. We research regulatory science for combination products. It’s very complex, because it’s a drug and device combination. And we are also providing regulatory information for manufacturers, both for medicinal products and for devices. In Korea, the bio industry is just booming up. It’s very much in high need in regulatory science and information. We are in academia, so we are connecting MFDS and the manufacturers. We have a very broad range of customers, starting from companies that have just started to large companies, pharmaceutical and medical device manufacturers. We are helping them to find out regulatory information from all around the world, the FDA, EMA and China, Japan. We also provide all the information for MFDS because they’re so busy. We collect all of the recent information and provide that so they can decide which regulatory pathway things have to go through. We also teach students about regulatory science. We have a very short history of regulatory science in Korea.
What does a day in that role look like for you?
I’m a professor at a college of pharmacy, so I teach pharmacy students. I teach clinical pharmacy and I also arrange the curriculum for them to become pharmacists. Myself, I’m a pharmacist too. I practiced for 10 years in the US as a clinical pharmacist. Then I moved back to Korea about 12 years ago. I graduated from the college of pharmacy at UGA, and I actually met someone from UGA here at RAPS Convergence. It was wonderful. I was very moved. I teach students and I also direct the Regulatory Strategy Center for Combination Products, the RSCP. I am a director and researcher, so I have a very busy life!
Why is regulatory affairs important, and how does it compare to other industries in the markets where you work?
Regulatory information and regulatory strategy is the most key information for supporting the manufacturers, and also at the government level and national level. Without this regulatory science, or regulatory strategy, it is impossible. You have to get approval before you get into the market. So without approval, it’s nothing. You can’t sell it. Compared to other industries — in Korea, we have a very big market for phones, like Samsung, electronics, like LG — but compared to those industries, this biopharmaceutical industry, they have to have regulatory information up-front. It’s key. It’s like a gateway. It’s very important.
What has your experience been like at RAPS Convergence?
This is great. I’ve gotten very informative information and I met so many people for the first time. The lectures were wonderful. This is great. The size of the conference, it was bigger than I had imagined. This whole exhibition is very informative, with some from universities, some from CROs and some from regulatory intelligence. I’m very impressed at all the different varieties of activities going on. On every corner they have lectures. The food is always there (laughs), and they’re talking all the time, ongoing discussions that are very active. It was very impressive. I’d like to bring my students next year.