Qingling Lian
supervisor
Regulatory Affairs
Qilu Pharma, Spain
Spain
Biography
Qingling is the supervisor of the Regulatory Affairs department at Qilu Antibiotics (Linyi) Pharmaceutical Co., Ltd., a subsidiary of Qilu Pharmaceutical group in China. The company focusses on API manufacturing including penems, cephalosporin, anti-cancer and common drugs. Qingling is responsible for the registration of these APIs globally. At this time, the Qilu team has successfully submitted USDMFs to the FDA, ASMFs for CEP and the EU, MFs in Japan and DMFs in PDF and NeeS formats to other countries such as Canada, Mexico, Korea. In cooperation with EXTEDO, they are currently converting their legacy submission formats to eCTD. It is a challenge but also a chance to make further significant improvements to their competitiveness in registrations.
Research Interest
Her area of research interest includes API manufacturing including penems, cephalosporin, anti-cancer and common drugs and in regulatory affairs.
