DIA 2016 Annual Meeting

Component Type: Symposium
Level: Intermediate
CE: CME 1.25; IACET 1.25; RN 1.25

In this symposium, the presenters are examining various innovative approaches to and requirements for conducting clinical trials in Japan, India, and Latin America, as well as how their respective regulatory environments have contributed to fostering innovation, product development, and clinical research.

Learning Objectives

Discuss the requirements for conducting clinical trials in Japan, India and Latin America; Share insights into innovative regulatory approaches that could impact clinical studies in these regions; Describe factors one needs to consider when conducting ethno-bridging studies outside the United States.

Chair

Larry A. Blankstein, PhD

Speaker

Issues and Solutions When Conducting Complex Caucasian Clinical Studies in Japan
Andrew Melli

Clinical Trials in India: An Update on Current Status
Charu Gautam, MD

Clinical Research in Latin America: Trends, Challenges and New Opportunities
Maria João Queiroz, MD

Component Type: Session
Level: Intermediate
CE: CME 1.00; IACET 1.00; RN 1.00

In August 2015, the Chinese Food and Drug Administration (CFDA) issued extensive changes to drug reviews and approvals. It has effectively redefined the definition of a new drug and the approval process for any new drug development as well as generics. While China is becoming the second largest pharmaceutical market, it would benefit all firms to carefully review and digest the impact of such a change to their global drug development planning; in turn, this allows them to take advantage of this change and properly adapt. This session will highlight the changes that have a direct impact on the clinical development strategy and share case studies with the audience to illustrate the best approach in handling these regulatory changes.

Learning Objectives

Recognize changes made by the Chinese Food and Drug Administration to drug reviews and approvals; Identify how to best leverage these changes for your new drug developments and generics.

Chair

Dan Zhang

Speaker

Innovative Biopharmaceutical Drug Development in China: Trends and Transformations
Helena Zhang

Regulatory Changes in China
Feng Yi

Outline of Reforming IND/NDA Practice in China
Fudong An

Component Type: Forum
Level: Intermediate
CE: CME 1.25; IACET 1.25; PDU 1.25 PMI 2166-000188; RN 1.25

In this forum, participants will learn and discuss practical techniques and tips for global stakeholder management, such as identification of key stakeholders. The focus will be on West-East hybrid R&D organizations.

Learning Objectives

Discuss practical advantages/limitations of stakeholder management implementation; Identify key success factors in global stakeholder management in pharmaceutical R&D; Describe ideas for effective implementation of global stakeholder management.

Chair

Atsushi Tsukamoto

Speaker

Panelist
Robert A. Hilke, MA

Panelist
Gareth Julian Monteath

Component Type: Session
Level: Intermediate
CE: CME 1.00; IACET 1.00; RN 1.00

This session will describe some of the unique challenges with conducting clinical trials in China. We will describe approaches and challenges with the application of good clinical practices and include information on how risk-based analyses can be used to select appropriate sites for further review and potential audit.

Learning Objectives

Describe approaches and challenges with application of GCPs in China; Identify how risk-based analyses can be used to select appropriate sites for further review and potential audit.

Chair

Daniel Liu, PhD, MSc

Speaker

Overview of Steps to Doing a Clinical Trial in China
Daniel Liu, PhD, MSc

Risk-Based Monitoring and Enrollment Pattern Analysis: Efficient Approaches for the Assessment Required by CFDA
Wenjun Bao, PhD

Update on Clinical Trials in China
Carol Zhu, MBA