Revised as of July 25, 2011
Click here to view the agenda.
Drug- and devicemakers are flocking to China to conduct clinical trials. More than 2,700 clinical trials have already been held in China (or are being planned), and in the coming years this growth is sure to continue.
And why not? China offers tremendous advantages:
Find out what you need to know to take your clinical trials to China — or improve yours if you’re already there — with this virtual conference from FDAnews and PAREXEL.
Lisa Rysso-DiMaggio, Principal Consultant, PAREXEL Consulting (Chairperson)
Carolyn Leahy, Director, WRS-Emerging Markets, Pfizer Global Research & Development, Sandwich Laboratories, UK
Kathleen Harris, Partner, Arnold & Porter, London, formerly Head of the Fraud Business Group, UK Serious Fraud Office
Marcus Asner, Partner, Arnold & Porter, New York
Min Yue, Senior Consultant, PAREXEL Consulting
Dr. Francis Crawley, Good Clinical Practice Alliance – Europe (GCPA) and Strategic Initiative for Developing Ethical Review (SIDCER)
Who Will Benefit
|10:00am – 10:10am||Introduction to the Virtual Conference|
|10:10am – 10:55am||The Promise and Pitfalls of Conducting Clinical Trials in China – A Regulatory Perspective|
|10:55am – 11:40pm||Best Practices in Sample Collection and Data Analysis for China-Based Trials|
|11:40am – 12:00pm||Break|
|12:00pm – 12:45pm||Informed Consent Best Practices: 10 Tips to Assure Compliance|
|12:45pm – 1:30pm||GCP Compliance for Clinical Trials: Investigator Qualifications and Site Selection|
|1:30pm – 2:30pm||Lunch Break|
|2:30pm – 3:15pm||US FCPA and UK Bribery Act Compliance: How a $100 Payment Could Wreck a Multi-million Dollar Drug or Device Clinical Trial|
|3:15pm – 4:00pm||Pan-Asian Clinical Strategies and Integration for Drug Development|
|4:00pm – 4:10pm||Closing Comments and Adjournment|
Chinese Clinical Trials — The Rising Star takes all the best elements of the best live conference you’ve ever attended – and avoids all the negatives. There’s no hassle getting away from the office, or travel and hotel expenses. Instead, you get valuable intelligence using the Internet for visual components and your speakerphone for the accompanying audio.
On the day of the event, all you do is go to the specified website and dial the specified toll-free telephone number, both provided in your registration confirmation.
That’s all there is to it. Then, relax at your desk or in your conference room, enjoying conference sessions featuring PowerPoint slide presentations, helpful handouts and Q&A opportunities where your specific questions will be answered direct answers from leading professionals.
About Our Chairperson
Lisa Rysso-DiMaggio, Principal Consultant, PAREXEL Consulting, manages worldwide regulatory operations teams, leads management of global regulatory projects and is a regulatory strategy and regulatory authority liaison.
Previously she was in charge of worldwide regulatory strategy for Pfizer, where she specialized in managing global regulatory teams and providing regulatory strategy for clinical trial and marketing applications in Africa, Asia, Latin America, the Middle East, Central and Eastern Europe and the Caribbean.
Lisa is working on a M.S. in Bioscience Regulatory Affairs from The Johns Hopkins University. She has a MS in Information Economics, Management and Policy from the University of Michigan and a BS in Physics from Eastern Michigan University. In addition, she has completed course work in Food and Drug Law, IND/NDA Submissions, and Drug Development through the Temple University/Pfizer distance learning program in Quality Assurance and Regulatory Affairs.
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