Expert 518341 - CA(S)


Expertise Description

I have more than 15 years of Pharmaceutical experience. My focus is regulatory affairs, of which my experience includes: drafting and filing IDE and IND applications, preparing correspondences and annual reports to FDA and IRBs, as well as responding to FDA audits, attending meetings, monitoring clinical trials, and training interns for regulatory compliance monitoring or auditing. I have developed regulatory strategies for innovative products, including drugs, biologics, devices and dietary supplements. I also have intellectual property experience, having acted as liaison for legal, bioinformatics, cloning, and screening departments regarding updates of existing inventions and the discovery of new genes, as well as participated in patent drafting and prosecution.

Areas of Expertise


Professional Experiences

My professional experience includes working as an adjunct and assistant professor at several universities. I have also worked as the Associative Director and Manager of consulting services, have been Partner of a patent group, and Manager of regulatory affairs institute.


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Relevant Experiences

I provide consultation on medical product regulations and approval process and executing FDA submissions for clinical investigators. I am also a faculty member in the Regulatory Science program at a prestigious university teaching drug and dietary supplement laws and generic drug patent exclusivity.
 
I teach dietary supplement regulations in Regulatory Science program and have served as a consultant to help register supplement products with the FDA. I am familiar with the regulatory requirements, as well as the regulations for health claims for dietary supplements.

I have been a patent agent for the past 15 years, and a patent owner for a polypeptide invention. Prior to my IP career, I conducted research in protein site-directed mutagenesis study and engineered polypeptides to study their effects on the immune system and to treat breast and prostate cancers. My research resulted in nine peer-reviewed publications. I am experienced in FDA regulations and approval process as well. I am also Regulatory Affairs-certified (RAC) and currently holding professorship at a prestigious university teaching and conducting research in FDA policy and regulations.

As one of the main instructors teaching the subject – The Generic Drugs, I constantly update my knowledge in this field and enrich the content with my own research on the approval records and IP information derived from the FDA databases and the Orange Book.

I also teach about 510(k) process at a prestigious university and make 510(k) submissions per request of our clients in the Consulting Service.


Education

Degree Subject Institution
M.S. Regulatory Science University of California Los Angeles
Ph.D. Biomedical Sciences University of California Riverside'
B.S. Biology Tunghai University Taiwan

Awards & Affiliation

Regulatory Affairs Professionals Society
Orange County Regulatory Affairs Professionals Society
Drug Information Association
The American Association for the Advancement of Science

Primary Affiliation

The American Association for the Advancement of Science



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