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Topics Related to Asia-Pacific Region [clear filter]
Monday, June 27

8:30am EDT

#111: Global Regulatory Harmonization in Asia: Is a New Trend Occurring?
Limited Capacity seats available

Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-16-551-L04-P; CME 1.25; IACET 1.25; RN 1.25

Recently we have seen increased efforts of Asian regulatory harmonization. Hear speakers from Asian agencies and industry and learn how they try to collaborate and harmonize regulations to enable more efficient drug development in this emerging region.

Learning Objectives

Discuss recent changes in drug development regulations in Asia; Describe the Asian regulation trend relating to harmonization with ICH and other global initiatives; Identify how the industry and regulatory agencies collaborate with each other for better and faster drug development by reviewing recent examples of global drug development utilizing multiregional clinical trials including Asia.


Akio Uemura, PhD


Update on Clinical and Regulatory Environment for Drug Development in Korea
Min Soo Park

Rapidly Changing Regulatory Landscape in China
Dan Zhang

Impacts of ICH E17 Guideline in Asian Drug Development
Yoshiaki Uyama, PhD

avatar for Akio Uemura

Akio Uemura

Executive Director, Head of Japan Development, Allergan Japan K.K.
1996: Head of biosciences lab, Mochida Pharmaceutical, 2000: Director, project management, EL Japan, 2004: Clinical phase global project manager, Eli Lilly, 2007: Director, regulatory policy, liaison and intelligence, EL Japan. 2011: Head of Japan Regulatory Affairs, Allergan Japan... Read More →

avatar for Min Soo Park

Min Soo Park

Chair, KCGI
Min Soo Park is a physician, trained specialist and Professor in Pediatrics (Neonatology) and Clinical Pharmacology. He received MSc in Clinical Pharmacology at Univ of Aberdeen, UK, and Ph.D. in Medicine at Ajou University, Korea. He served as VP of KoNECT and is in charge of clinical... Read More →
avatar for Yoshiaki Uyama

Yoshiaki Uyama

Director, Office of Medical Informatics and Epidemiology, Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Yoshiaki Uyama, PhD, is Director, Office of Medical Informatics and Epidemiology, for the Pharmaceuticals & Medical Devices Agency (PMDA), Japan. His experience in the safety review and assessment of new drugs for PMDA includes serving as the Review Director; as International Conference... Read More →
avatar for Dan Zhang

Dan Zhang

Executive Chairman, Fountain Medical Development Ltd. (FMD)
Dr. Dan Zhang, the Executive Chairman of Fountain Medical Development, has more than 15 years of drug development experience. Previously, Dr. Zhang was the Head of Clinical Development and Global Safety Assessment at Sigma-Tau Research Inc., Vice President at the Quintiles Transnational... Read More →

Monday June 27, 2016 8:30am - 9:45am EDT
204B Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
  Trk 08: Reg Affairs, Session

10:45am EDT

#123: Global Clinical Trials: Innovative Approaches to Clinical Trials in Japan, India, and Latin America
Limited Capacity seats available

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.


Larry A. Blankstein, PhD


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

avatar for Larry Blankstein

Larry Blankstein

Consultant, Clinical Development, Blankstein Consulting Group
Dr. Larry Blankstein is an independent Senior Consultant to the Pharmaceutical and Biotechnology industry. He has over twenty-two years experience in drug development strategy, clinical operations and mergers and acquisitions. He received his Ph.D. degree in Biology from Wesleyan... Read More →

avatar for Charu Gautam

Charu Gautam

Senior Medical Director, IQVIA
Charu Gautam is a Physician with over 20 years experience in research and academics. Been associated with leading companies in India to lead the clinical operations and medical teams. Qualified as MBBS, MD and a board certification in Clinical Pharmacology . She is also a lead faculty... Read More →
avatar for Andrew Melli

Andrew Melli

Senior Manager, SOUSEIKAI Global Clinical Research Center
Andrew Melli is the Senior Manager of Global Clinical Development at SOUSEIKAI Global Clinical Research Center, serving as both liaison for international business development and investment, as well as an active member of the clinical trial team. It is his hope to help bridge the... Read More →
avatar for Maria João Queiroz

Maria João Queiroz

Global CEO, Eurotrials Scientific Consultants
More than two decades at executive leadership positions in the pharmaceutical industry, Founding Member & CEO at Eurotrials, a CRO in Europe and Latin America. With a Degree in Medicine, specialization in Immunohematology and a post-graduation in Pharmaceutical Medicine. Has active... Read More →

Monday June 27, 2016 10:45am - 12:00pm EDT
113B Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
  Trk 01: Clinical Operations, Symposium
Wednesday, June 29

10:30am EDT

#309: Global Stakeholder Management: Across the Ocean Between East and West
Limited Capacity seats available

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.


Atsushi Tsukamoto


Robert A. Hilke, MA

Gareth Julian Monteath

avatar for Atsushi Tsukamoto

Atsushi Tsukamoto

Vice President, New Drug Regulatory Affairs, Daiichi Sankyo Co., Ltd.
Atsushi is VP of New Drug Regulatory Affairs (RA) at Daiichi Sankyo. He is also Head of Specialty Medicine RA in R&D division, to lead gobal specialty medicine regulatory strategies. As Head of Japan New Drug RA, he is responsible for leading new drug RA activities for all projects... Read More →

avatar for Robert Hilke

Robert Hilke

Chief Executive Officer, Hilke Communications Corporation
Robert Hilke is the CEO of Hilke Communications Corporation, a firm specializing in providing intercultural communications and TOEIC training for global businesspeople, many of whom work in the pharmaceutical industry. Mr. Hilke's primary research interest is the management of diverse... Read More →
avatar for Gaz Monteath

Gaz Monteath

Executive Director, Link Global Solution Inc.
Dr. Gareth ("Gaz") Monteath is Executive Director at Link Global Solution Inc., an HR and OD consulting firm based in Tokyo. In his position, Gaz is responsible for the overall content and quality of programmes. LGS has long experience of working with pharmaceutical and medical instruments... Read More →

Wednesday June 29, 2016 10:30am - 11:45am EDT
105AB Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
  Trk 02: Proj/Port Mgt/Strat Planning, Forum