Chinese Clinical Trials — The Rising Star Surefire Strategies For Conducting On-Time, Cost-Effective, Data-Sound Drug and Device Clinical Trials

$897.00
 


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:

  • Low cost:  Estimates suggest savings of as much as 50% versus running trials
    in Western Europe or the United States.
  • Big pools of "treatment-naive" patients — the faster your recruiting numbers are
    met the faster you can complete your trial and get your product to market.
  • Increasing comfort from sponsors and regulators alike about the quality of the data
    from trials conducted in China.
  • Worried about your intellectual property in China?  Don’t be.  Chinese IP protections
    are getting stronger.

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.

Register Now

Speakers Include
 
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

  • Chinese Clinical Operations Specialists
  • Scientific and Medical Affairs Directors
  • Regulatory Affairs Directors and Liaisons
  • Patient Recruitment and Clinical Trial Specialists
  • Clinical/R&D Operations and Research Personnel
  • Clinical QA/QC Personnel
  • Strategic Planning and Operations Directors

Agenda

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

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What are the benefits of a virtual conference?

  • Highly effective communication: This event uses Internet and audioconferencing to create
    a seamless interface and deliver vital compliance and management advice with every day
    technology found in every workplace.
  • Great value: Select as many of your colleagues to attend as you wish, and then educate
    all of them for one low price, with no travel, lodging or per diem expenses.
  • Stress-free: You never leave your building, so there’s no hotel or airport nightmares. You’ll
    feel like you’re off-site at a top-flight conference, but you’ll still be able to come and go as
    you please and keep track of your daily work.
  • Efficient: You can assign your staff to different sessions.  Staffers can go to the sessions
    that most pertain to their responsibilities.
  • Interactive: No one-way street, you’ll have plenty of opportunities to ask questions and
    get involved.
  • Up to the minute: This program will be up to the minute with the very latest requirements
    from the FDA and other international regulatory bodies incorporated into the event.
  • Comprehensive: You’ll hear from leading industry experts all in the course of one day.

How does a virtual conference work?

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.