Roundtable Forum: Generic Drug Review and Regulations

Organizer: American Chinese Pharmaceutical Association (ACPA)

I. Target Audiences

Professionals in the area of research and management from universities and regulatory organizations. Professionals from R&D, Quality Control, Quality Assurance and Regulatory Affairs in pharmaceutical companies and research institutes.

II. Objectives

Upon attending this roundtable forum, the audiences should gain a general understanding of the new regulations and practices under the Generic Drug User Fee Act (GDUFA) in three major review areas in the abbreviated new drug applications (ANDAs): 1) drug products, 2) drug substances, and 3) bioequivalence.

III. Program content

• Overview of new regulations and practices for ANDA review in the era of GDUFA

• Different fee programs

• New review work flows

• Drug product (CMC) review and commonly seen deficiencies

• Drug substance (DMFs) review and commonly seen deficiencies

• Bioequivalence review and commonly seen deficiencies

• Bioequivalence for-cause inspections and commonly seen issues

IV. Speakers

Bing Li, Ph.D., Division of Bioequivalence/OGD/CDER/FDA

Huyi Zhang, Ph.D., Division of Chemistry/OGD/CDER/FDA

Haitao Li, Ph.D., Division of Chemistry/OGD/CDER/FDA

Geoffrey Wu, Ph.D., Division of Chemistry/OGD/CDER/FDA

V. Time: 9:00 am – 12:00 pm; April 25, 2013

VI. Location: Hilton Hotel, 620 Perry Pkwy Gaithersburg, MD 20877