Acceptability of Clinical Trials Data in China, India and Asia for Global Marketing Application

COURSE DETAILS

18  July 2013, Singapore 2pm - 3pm 
Singapore

Normal Course Fee: 79 usd/seat

Company Bulk: 299 usd/up to 6 seats

(Certificate of Participants to be issued)

 

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ICH GCP is considered to be gold standard for the conduct of clinical trials globally. Data from ICH regions: the United States, Europe and Japan, will automatically be accepted as part of a submission for a marketing authorisation in these regions.  Increasingly, data from outside ICH regions, including India, China and Asia are being used to support applications for Marketing Authorisations for Pharmaceutical Products. 

 

This useful training will explore the minimum standards expected by the FDA and EMA for clinical trial data used to support a global MAA in these regions.

 

COURSE OBJECTIVE

Upon completion of this program, participants will be able to:

  • Understand the guidelines available for minimum Good Clinical Practice standards globally;
  • Comprehend the minimum ethical and Quality standards for the acceptance of data for marketing submissions in India, China and Asia;
  • Evaluate the impact on the clinical trial design and extrapolation on data to be used in global marketing authorization applications for pharmaceuticals.

 

WHO SHOULD JOIN 

  • Managers 
  • Personnels working in CROs and Pharma
  • Clinical Research Coordinators/Associates
  • Clinical Research Professionals
  • Clinical Scientists/Basic Scientists
  • Clinical Investigators/Principal Investigators
  • Clinical Quality Assurance Professionals
  • Project Managers
  • Clinical Study Coordinators

 

Distinguished Trainers

Ms Trish Parry BSc (Hons), FICR, CSci, Director & CEO, Otus Clinical Services Ltd

Trish Parry is a clinical research consultant with 30 years’ experience in the pharmaceutical industry and 23 years’ experience in clinical research. Trish has extensive experience in global monitoring and International clinical project management as a result of working in multi-national pharmaceutical companies including Genzyme, US Bioscience and Allergan and clinical research organisations including Quintiles. Read More