Chinese Clinical Trials Virtual Conference Agenda



Revised as of July 25, 2011

10:00 a.m. – 10:10 a.m.

Introduction to the Virtual Conference

Chairperson, Gabriela Rossi, Principal Consultant, PAREXEL Consulting

10:10 a.m. – 10:55 a.m.

The Promise and Pitfalls of Conducting Clinical Trials in China – A Regulatory Perspective
The number of clinical trials in China has exploded. China offers advantages to industry not found elsewhere: large numbers of untapped research subjects, a capable work force, well-functioning health systems and reduced costs. The first and most important step to developing or improving successful clinical trials in China is to understand and recognize the unique regulatory landscape and Asian business and social customs.

Attendees will:

  • Delve into the key regulations in China involving clinical trial management, monitoring and auditing
  • Understand why nuanced variations in regulatory procedures should be monitored closely — less you risk sanctions
  • Discover the characteristics of China-based R&D and ethics committees, including the role they play and what it means for both sponsors and sites

Carolyn Leahy, Director, WRS-Emerging Markets, Pfizer Global Research & Development, Sandwich Laboratories, UK

10:55 a.m. – 11:10 a.m.

Break

11:10 a.m. – 11:55 a.m.

Human Subjects Protections Management in Clinical Trials in China: A Transnational Perspective
This presentation examines current practices and actions underway in China to manage ethics committees (IRBs), patient informed consent, and the ethics of clinical trials generally in China. It will also examine the role of the Ministry of Health and the State Food and Drug Administration (SFDA) in promoting good clinical practice and new guidance on ethics committees is discussed. The presentation also looks at the current system of SFDA approved clinical trials sites and the management of ethics committees and informed consent practices at the sites.

Attendees will learn:

  • The regulatory and institutional frameworks for human subjects protections in China
  • The development of ethical review practices and the management of IRBs in China
  • Steps toward developing a national system for the recognition and accreditation of ethics committees in China
  • Challenges in addressing informed consent in China: urban vs. rural research, oncology research, paediatric research
  • Informed consent and patient recruitment in China
Dr. Francis Crawley, Good Clinical Practice Alliance – Europe (GCPA) and Strategic Initiative for Developing Ethical Review (SIDCER), Brussels, Belgium

11:55 a.m. – 12:40 p.m.

GCP Compliance for Clinical Trials: 5 Tips for Qualifying Investigators and Sites (prerecorded due to time difference in China)
Sponsors spend hundreds of thousands of dollars researching, qualifying and readying clinical sites and investigators for China based trials. If this due diligence isn't done effectively and GCP violations occur, it could mean delays in meeting trial goals or international regulatory sanctions. If quality sites and investigators are selected — those that meet recruitment goals on time, execute the study protocol successfully and are audit ready — the trial will likely finish on time and yield evaluable data. Choosing quality sites and investigators is essential to getting your trial done on time and correctly. Plus, sponsors whose trials start and end on time are a step ahead of their competition.

Attendees will learn:

  • Insight on site/investigator recruitment — how to ensure you can recruit the right sites/investigators for the right studies and vice versa
  • The red flags that warn of trouble with a site/investigator before and during a trial
  • Site/investigator interview techniques — the best ways to ask questions and answers to look for
  • Guidance on how to strengthen the site-sponsor relationship and lay the foundation to enable sites to meet enrollment goals and understand GCP expectations
  • Contractual risk-sharing language and strategies for ensuring equitable distribution of risks
  • Warning signs for when a site/investigator is in distress and how to get back on track or make a graceful exit

Dr. Yan Wu, Medical Director, Biogen China

12:40 p.m. – 1:40 p.m.

Lunch Break

1:40 p.m. – 2:25 p.m.

US FCPA and UK Bribery Act Compliance: How A $100 Payment Could Wreck a Multi-million Dollar Drug or Device Clinical Trial
The US and UK governments are pursuing violations of the Foreign Corrupt Practices Act (FCPA) and Bribery Act at an increased rate. The definitions for the FCPA and the UK Bribery Act provisions are not always obvious and can lead to confusion and unintentional violations. In addition to a devastating blow to a drug or device’s approval prospects, violations can include multimillion-dollar fines.

Attendees will learn:

  • Best practices for implementing adequate controls governing clinical trial conduct and other common foreign business activities
  • Key FCPA cases in the drug and device sector and the lessons learned
  • Essential training and compliance procedures to manage FCPA and Bribery Act risks in a multinational drug or device company

Marcus Asner, Partner, Arnold & Porter, New York
Kathleen Harris, Partner, Arnold & Porter, London, formerly Head of the Fraud Business Group, UK Serious Fraud Office

2:25 p.m. – 3:10 p.m.

Pan-Asian Clinical Strategies and Integration for Drug Development
China’s State Food and Drug Administration (SFDA) is updating their laws, provisions and guidelines on a regular basis. There were major structural changes at SFDA/CDE in 2010, resulting in added complexity in the regulatory environment and processes for drug development that manufacturers need to be aware of if they plan to seek product registrations in China.

Attendees will learn:

  • Examination of China’s regulatory system and SFDA structure; including regulations and guidelines, current regulatory environment and trends
  • Updates on the challenges and opportunities in clinical application and MA approvals
  • Cases studies in successfully developing biopharmaceutical products in China

Min Yue, Senior Consultant, PAREXEL Consulting, Indianapolis, IN

3:10 p.m. – 3:20 p.m.

Closing Comments and Adjournment

Chairperson, Gabriela Rossi, Principal Consultant, PAREXEL Consulting, Boston, MA