News Release

Graduate students and instructors from Peking University (PKU) visited the Johns Hopkins University's master of science in bioscience regulatory affairs program on September 29th to broaden their understanding of bioscience product development, quality assurance, and international regulatory affairs.

"The goal of the visit was to address China's manufacture of biopharmaceuticals for export to the U.S. and the approval requirements of the Food and Drug Administration," said Lynn Johnson Langer, associate program chair of the master of science in bioscience regulatory affairs program. "As we strengthen this relationship with Peking University, we will effectively be building a biotech bridge to China that creates greater understanding of international regulation and product development in a global marketplace."

The visitors are part of PKU's international pharmaceutical engineering management program and the meeting served to expand a relationship between the two schools that began when Langer traveled to China in 2006 to discuss mutually beneficial education opportunities between the two universities.

During their visit, PKU students attended two lectures by Johns Hopkins instructors at the university's Montgomery County Campus. First, Nancy Karaskiewicz spoke about "Quality by Design." Then, Ning Li, a team leader in the FDA's Office of Surveillance and Biostatistics, gave a lecture in Chinese about online education, citing content from his own online course at Johns Hopkins. The students also toured the offices of the Food and Drug Administration and U.S. Pharmacopeia.

Langer has returned to China since 2006 to guest lecture about Johns Hopkins' part-time, online graduate programs in biotechnology, and two lecturers from PKU have since guest lectured at Johns Hopkins. Representatives from the two universities are now discussing opportunities for joint online lectures, utilizing a virtual classroom, to create a unified educational experience.

According to Langer, as a result of the meeting, PKU faculty will guest lecture next spring in a Johns Hopkins online course titled, "Marketing in a Regulated Environment."

About Johns Hopkins' Master of Science in Bioscience Regulatory Affairs
In a market of expanding drug and product development and the need to comply with federal and state regulations, companies and federal agencies report an increasing need for trained professionals educated in bioscience regulatory affairs. To meet this need, Johns Hopkins offers a master of science in bioscience regulatory affairs program that taps the expertise of professionals from the federal government, industry, and academia.

About Peking University's Master's Degree in International Pharmaceutical Engineering Management
In July 2006, Peking University announced a new master's degree program in international pharmaceutical engineering management, which is dedicated to quality management and regulatory science. This program is the result of close collaboration between Peking University and FDA. The long-term goal of this program is to accelerate the modernization of China's pharmaceutical industry, as well as to provide the basis for a satisfying professional career with success and accomplishment for graduates.