Dr Zheng Yiying standing beside an NMR Spectrometer. Photo credit: M. Fadly.
Have you ever wondered who regulates and approves the drugs used in Singapore and around the world?
Regulatory affairs specialists, alongside other important related jobs, work to ensure that drug quality meets the stringent benchmarks before they can be tagged as “safe for consumption”. Given that the slightest contamination in drug composition can seriously endanger the life of a consumer, drugs require a rigorous examination before they can be released to the public.
In SPMS, Dr Zheng Yiying has recently launched a new undergraduate Chemistry module, CM9201, which provides students with an overview of regulations in three important areas of industry: Pharmaceutical Drugs, Biologics, and Medical Devices. Regulatory affairs comprise of the rules and regulations that govern product development, and post-approval marketing. We caught up with Dr Zheng to ask her about herself, and her reasons for creating this new course.
1. You are an NTU Alumni – what have you studied for your undergraduate programme, and which year did you graduate?
I was a typical SPMS student back in my school days, and I majored in Chemistry and Biological Chemistry with a Concentration in Medicinal Chemistry, and a Minor in Mathematics. I am honored to be a member of Class 2012!
2. How did you come to be interested in chemistry?
My interest in Chemistry started to grow after being involved in multiple science projects in secondary school. I still remember one of my first science projects, using an orange to conduct electricity.
3. Is this your first-time teaching in NTU? Have you always wanted to go into teaching?
Yes, it is my first-time teaching in NTU. I am very excited, and nervous at the same time. Yes, I love teaching! I have been teaching since my time as an undergraduate.
4. How would you describe your current job scope?
My current job scope is to assist a local start-up to build a quality management system, obtain regulatory approvals for their medical products, and help to launch their medical products in Singapore and eventually, in the United States.
5. You have studied in the United States, what was your best memory or experience back then? For example, funny, adventure or cultural?
The most thrilling memory when I studied in the United States was travelling on a self-drive road trip, followed by a 3-day-2-night camping trip in the wild at Yosemite with friends from around the world. We rotated to start fire using splint, a pocketknife, cardboards and sticks throughout the whole day to cook food and keep ourselves warm. On the first night, we were stunned and frightened when a black bear appeared, but we managed to scare away the bear by throwing firesticks at it. Still traumatized by the unprecedented event, we ended up staying awake and gathered to share our fond memories that we experienced in our lives throughout the night. Our initial plan was to depart the next day, but we decided to stay on because of the picturesque scenery that Yosemite has to offer. And I am glad we did… An interesting woodpecker popped by for a visit and a few mule deer casually strolled past our tent. All in all, it was the best wildlife experience we ever had.
6. What are your hobbies?
I have multiple hobbies which include interactive games, reading, writing, regulatory affairs, and Zumba.
7. Do you have a hidden talent? (For example, singing, and martial arts)
Zumba.
8. Can you describe your aspirations as a female scientist?
Ever since the #MeToo campaign went viral, and having stayed near Hollywood at that time, there has been a strong advocate for women to be represented in all walks of life without the need to deal with sexual harassment and abuse. As a scientist, it is very discouraging to hear that women were often under-represented in science and technology roles.
To handle this, I helped gather women in the science and engineering departments together at USC, who volunteered to organize motivational talks and scientific presentations to girls from elementary, middle and high schools in LA area, and to encourage them to venture into science, research and academia as there is a lot more that they can contribute to the society, from making a great discovery to saving lives.
Back at USC, I was a social media coordinator for USC Women in Chemistry (WiC). I created a Twitter page (@usc_wic) to publicize WiC events and activities. These events and activities not only helped to bring female (and sometimes male) undergraduates and graduates together, but also served as a platform for female faculty members to act as role models to share their experiences during the events and activities.
9. Could you give us a brief summary on what would be taught/learnt in this course?
Students should be able to explain the history and rationale behind policy, law and regulation pertaining to food and drug laws in global context, describe aspects of specific laws and regulations that are applicable to drugs, biologics and devices, and able to explain market clearance requirements and processes.
10. How do you choose what content to include in the course?
Regulatory is a field that is constantly changing, so as a new lecturer for this introductory course, I must be constantly updated with the ongoing news. I would say, “raps.org is a good place to start,” if you are interested to find out more news on regulatory context globally.
11. What could students expect from this module?
To the new and aspiring scientists and engineers who are contributing to the development of novel pharmaceuticals, biotechnology and medical devices, it is important for them to be aware of the legal, technical and administrative procedures that the different regulatory bodies must adopt to ensure the biologics, medical devices, and the safety, efficacy and quality of drugs meets the standards set by the regulatory authorities before introducing to the market. Throughout this introductory course, students would learn about the rules and regulations that govern the medical product development, from benchwork lab discoveries to post-approval marketing.
12. Any advice to our current undergraduates?
Keep an open mind, learn as much as you can while you are still young. The skills you have acquired will accumulate and may be useful one day!