We would like to get you all acquainted with our NMPA and Clinical study expert, Stephanie Huang. An interview where we talk about her expertise, how a normal workday looks like and which trends she observes in the MedTech-world. Ending the interview with valuable advice for everyone in the MedTech world!
Could you give us a small introduction about yourself?
I was raised in China, studied in Australia, joined a multi-national company there after graduation, and then moved to a British CRO. I have been working for Qserve since 2013 and provide regulatory consultation to clients worldwide. I enjoy working with multi-national and multi-cultural colleagues and clients, and bridging the regulatory practice between the west and the east. I am now based in China and managing Qserve China’s overall operation and projects.
What is your main area of expertise?
My focus is on NMPA regulatory strategy and providing practical advice on the conformity route to speed up the product launch in the Chinese market. When a client is investigating entry requirements to the China market, their products may be already on the market in their home-country. I will help them to understand the similarities, differences, and gaps between the markets.
Could you tell me something about your experience before you joined Qserve?
Before I joined Qserve, I lived in Australia several years for my study and I also worked there for a Sino-Australia clinical development project.
When I moved back to China, I started to work for a British drug development company’s branch office in China. I helped them to interpret the local pharmaceutical regulations, I developed local clinical sites, helped them identifying KOLs, and the project management for studies in China mainland and Hongkong.
Which part of your job do you prefer the most?
Having the opportunity to hear the voices from the manufacturers’ perspective, telling them how the regulators may view this, and then finding a solution together always fulfills my day. I also really enjoy bridging gaps and working a way through to become more efficient and effective.
What does a normal workday looks like for you?
I start each day with planning. I have a habit to write down tasks on a to-do-list for a daily, weekly and monthly basis, and set priorities. Then I will review the calendar to have an overview of the appointments, visits and T/C etc. Afterwards, I will check the on-going projects progress, timelines and status. Some uninterrupted time will be reserved to focus on reviewing the technical files or clinical assessments as well. Due to the large foreign client base and our branch offices globally, I am also used to work around the clock to be more flexible on various time zones.
Do you prefer a specific type of medical device?
I do not prefer a specific product. My work is to help clients solve the problems they are facing and improve the files quality to meet market entry requirements. Although the medical devices could cross a big span from fields perspective, the regulatory compliance mentality stays the same. No matter if the companies are small or big, lower or higher risk products, matured technology or innovative one, they may all face challenges and need advice.
Which topics are trending at the moment?
The new revision to the China medical device fundamental regulation Order 680 is just approved by the State Council. This may bring many changes to the compliance requirements for both domestic and foreign manufacturers in the 2021.
How do you stay up to date with everything that is happening in the MedTech-world?
I check NMAP and CMDE websites frequently to keep myself updated. I also subscribed to several informative newsletters from the med-tech industries and will read their articles. We also have a regulation intelligence exchange platform to learn from each other.
What is your advice for our customers?
Stay tuned with China regulations updates, as they are dynamically changing!
Would you like to know more about Stephanie? Click here for her full profile.