Activities

FDAAA Co-sponsors Korea FDA Training on Generic Drug Regulatory Science

Two FDAAA members, Doug Sporn and Chi-wan Chen, conducted a 2 ½ day workshop August 9-11, 2010 on the US generic drug review and approval process for the Korea Food and Drug Administration (KFDA) in Seoul. The workshop was KFDA’s first Competence Enhancement Program for Global Drug Review. This was the FDA Alumni Association’s fifth co-sponsored international training in 2010, the others being for the DIA African Regulators Conference, DIA China, China’s SFDA, and US DIA.

The KFDA contacted FDAAA’s International Network several months ago seeking help identifying individuals with prior FDA experience who could develop and lead such a workshop. The goal of the workshop was to increase the staff’s awareness of the scientific and regulatory policies FDA uses in its review and approval of generic drugs. With this information KFDA hopes to identify policies and practices that it may use to strengthen its own review process.

Before leaving FDA, Doug was the Director of the Office of Generic Drugs and Chi-wan was the Deputy Director of the Office of New Drug Quality Assessment in CDER. Between the two of them they covered the FDA laws and regulations applicable to pharmaceuticals, the overall process by which generic drug applications are filed, reviewed and approved as well as specific requirements for chemistry, manufacturing and controls, demonstration of bioequivalence, labeling, and electronic submissions.

Approximately 100 KFDA staff members attended the full 2 ½ days of the workshop. The presentations were well received and the question-and-answer sessions actively participated in by the attendees. Among those attending were the Directors General of the Pharmaceutical Safety Bureau and the Drug Evaluation Department, Byung-Won Jang, Ph.D., and Sun Hee Lee, Ph.D., respectively, and their division directors. At the end of Day 2, Chi-wan and Doug were greeted by Mr. Yun-Hong Noh, KFDA Commissioner, who expressed his appreciation for FDAAA’s willingness to provide the workshop and hoped that KFDA and FDAAA would continue to foster this kind of cooperation and knowledge exchange in the future.

The KFDA press release from August 9, 2010 has been translated into English, below.

FDAAA International Network will make slides available upon request. If used, attribution to creator and FDAAA is requested.



Photo: Front row 5th from left going to right: Byung-Won Jang, Director General, Pharmaceutical Safety Bureau, Doug Sporn, FDAAA, Chi-wan Chen, FDAAA and Executive Director, Global CMC, Pfizer, Sun Hee Lee, Director General of KFDA's Drug Evaluation Department


August 9 2010

Upgrade Capability of Drug Approval and Review to the World-class Level

- Direct Education from Former FDA Staff -

KFDA (Commissioner Yun-hong, Noh) addressed that they would invite former FDA staff to KFDA to enhance capability of KFDA’s reviewers up to global level through an education and training workshop on August 9-11, 2010 under the theme of ‘Overview of U.S. Regulatory System for Generic Drugs’.

  • The KFDA education and training workshop is sponsored by U.S. Food and Drug Administration Alumni Association (FDAAA) whose members are previously employed by the FDA. FDAAA is a non-profit, non-lobbying organization dedicated to serving those who have supported the consumer protection mission of the U.S. FDA. The workshop touches on Law and Regulation, Approval Process, CMC Submission and Review, Bioequivalence, Labeling and Post-approval CMC Changes.
  • Two FDAAA members* who have much experience with generic approval and evaluation provide lectures and presentations.
    • Chi-wan Chen, Ph.D. (The former Deputy Director, Office of New Drug Quality Assessment, CDER, US FDA)
    • Doug Sporn (The former Director, Office of Generic Drugs, CDER, US FDA) KFDA expects that this workshop will help KFDA staff better understand the U.S. drug approval and evaluation system, not only improving pharmaceutical safety management in Korea but also encouraging Korean pharmaceutical companies to advance into the global market.
  • KFDA also expects to expand areas to be covered by the workshop with FDAAA members to new drugs and OTC review in the future. Further, workshop programs for Korean pharmaceutical companies will be developed by KFDA as well.