Workshop: Review and Technical Issues for Drug Substances


Sponsor:

American Association of Pharmaceutical Scientists (AAPS)


Chinese Medicine Education Association (CMEA)



Organizer:

AAPS PPB International Outreach Committee


American Chinese Pharmaceutical Association (ACPA)


Beijing CANNY Consulting Inc. (BCC)



I. Target Audiences

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

II. Objectives

Upon the completion of this workshop, the audiences should gain a good understanding and learn the best practices in the following areas:

At the end of the workshop, AAPS/CMEA certificates will be awarded to the participants upon successful evaluation.

III. Program content

IV. Speakers

Haitao Li, Ph.D.: CMC reviewer, FDA

Bingyan Wu, Ph.D.: CMC reviewer, FDA

Lian Yu, Ph.D.: Professor, University of Wisconsin ‒ Madison

Geoff G. Z. Zhang, Ph.D.: Senior Research Fellow, AbbVie

Huyi Zhang, Ph.D.: CMC reviewer, FDA

V. Time: Three days (May 24-26, 2013)

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