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Half-day Workshop1: Individual Case Safety Report (ICSR) Medical Review (morning)

May 11 2014 8:30AM - May 11 2014 12:00PM | Shanghai International Convention Center No. 2727, Riverside Avenue Pudong 200120 Shanghai China

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Overview 

Individual case safety report (ICSR) is fundamental in the safety surveillance of medicines. It is therefore important to capture information on ICSRs in a structured manner and to the highest possible quality standards to support accurate  detection and analysis of drug safety signals. With the quick development of Chinese pharmaceutical companies and contract research organizations, there is an urgent need for our local reviewers to have both higher capacities and more  experience in ICSR medical review, keeping the pace with the professionals around the world. Moreover, local pharmaceutical community will need to comply with the global standards of ICSRs reporting, such as major agencies’ requirement and ICH guidelines, to make the products approved globally, to improve the monitoring of the medicinal products already on the market, thereby to ensure the safety of patients using medicinal products. The most common challenges in ICSR  medical review are accurate event coding, expectedness and causality assessment. This workshop will provide the audience both introduction of global standards and practicing experience.

Who Should Attend 

  • ICSR reviewers
  • Safety risk management of medicinal products
  • Medical writers who develop CSRs
  • Data managers and operators who need interact with ICSR medical reviewers

Learning Objectives 

  • Know the points to consider for high quality event coding
  • Learn how to perform the accurate expectedness assessment in individual cases
  • Know the various methods for causality assessment in ICSRs and the requirement in FDA final rule
  • Learn how to perform appropriate causality assessment using the method of Global Introspection based on FDA final rule

Contact Information 

For general inquiries and registration, contact
Mr. Fei XIE
Phone +86.10.6260.2240
fei.xie@diachina.org or dia@diachina.org

For exhibiting, hosting, and advertising inquiries, contact
Ms. Jean XU
Phone: +86.10.5923.1096
jxu@kellencompany.com

To Register, click here.

Instructor(s) 

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