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China Update: Regulatory Changes and Implications

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Overview 

Continuing Education credits are not available for the archived offering.
This archived webinar is available for purchase through November 27, 2014.
Broadcast time: 1 hour 29 minutes


Recently, the China Food and Drug Administration (CFDA) has implemented or proposed several important changes in its regulations concerning drug registration, clinical trials and other areas.  There have also been changes in the regulatory review practice in areas such as Multi-regional Clinical Trial (MRCT) for China registration.  Additionally, the CFDA has started the revision of the “Drug Administration Law” which is in place to ensure drug quality and safety.  These changes will continue to drive the evolution of the Chinese regulatory environment, directly impacting the strategy, planning and execution of the pharmaceutical companies in the development and registration of new products in China.  In this webinar, experts will review some of these regulatory changes, discuss the potential impact and share insight on how to address issues arising from these changes.


Presentations on
Recent and Upcoming Changes in Law, Regulation and Regulatory Practice
Industry’s Response and Strategies

 

Who Should Attend 

Professionals involved in:

  • Regulatory Affairs
  • Legal
  • Regulatory Policy
  • Research and Development
  • Strategic Planning
  • Clinical Development

Learning Objectives 

At the conclusion of this webinar, participants should be able to:

  • Describe the recent and upcoming key changes in Chinese drug regulation and regulatory review practice
  • Explain the potential impact to the industry of these changes
  • Discuss strategies to address issues arising from these changes

 

Contact Information 

Printable Registration Form

Registration Questions
Toll Free 1.888.257.6457
Phone +1.215.442.6100
Fax +1.215.442.6199
Monday-Friday 8:30AM-8:00PM ET
CustomerService@diahome.org

For further information, contact
Carolyn Callahan
Phone +1.215.442.6194
Fax +1.215.442.6199
Carolyn.Callahan@diahome.org

Technical Requirements 

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Presenter(s) 

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Agenda  

Day 1 Wednesday, May 28, 2014

  • 9:00AM - 11:59PM

    China Update: Regulatory Changes and Implications

    Speaker(s):

    • Moderator
      Jian Peng
      Clinical Research Director
      Sanofi (China), China
    • Recent and Upcoming Changes in Law, Regulation and Regulatory Practice
      Chen Yang, JD
      Partner
      Sidley Austin LLP Beijing Office, China
    • Industry’s Response and Strategies
      Janet Lu, MS
      Head of Regulatory Asia Pacific
      Roche , China

Registration Fees 

Other Fees

Group Site
$799.00
Group Plus
$1499.00

Member

Member Government Individual
$125.00
Charitable Nonprofit/Academia Member Individual
$175.00
Member Individual
$250.00

Non-Member

NonMember Government Individual
$125.00
Charitable Nonprofit/Academia Nonmember Individual
$175.00
NonMember Individual
$350.00
Registration Information

Printable Registration Form

  • Individual registration is a license for ONE internet login allowing one viewer.
  • Group site registration is a license for ONE internet login allowing multiple viewers from one location.
  • Group Plus is a license for up to FIVE internet logins allowing one or more viewers at each login location.


Cancellations:  No refunds will be provided in the event of a participant’s cancellation since all costs for this webinar have been prepaid by DIA. DIA reserves the right to modify or cancel programs and/or substitute presenters or panelists. DIA is not responsible for failure to deliver programs due to circumstances beyond its control.

Participants with Disabilities: Reasonable accommodations will be made available to persons with disabilities who attend an educational activity. Contact the DIA office in writing at least 15 days prior to event to indicate your needs.

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