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Workshop3: Early Clinical Development from First-in-Human (FIH) to Proof of Concept (POC)

May 11 2014 8:30AM - May 11 2014 5:30PM | Shanghai International Convention Center No. 2727, Riverside Avenue Pudong 200120 Shanghai China

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Overview 

The workshop is designed to meet the growing needs in China for training of early drug development from First-in-human (FIH) to Proof of Concept (POC), where the first evidence of clinical efficacy is demonstrated in the target disease of interest. How to safely and efficiently to manage this early phase of clinical development using clinical pharmacology principles, modelling and simulation approaches, innovative POC design, robust clinical operation and monitoring will be discussed. At the end of the workshop, a panel discussion will be organized with regards to current challenges and future perspectives in early clinical development in China.

Who Should Attend 

  • Professionals in pharmaceutical R&D (Local & global MNCs)
  • Staff & managers from Ph1 units
  • Professionals in translation medicine or experimental medicine research
  • Physicians/ healthcare professionals involved in the early clinical development
  • Clinical pharmacologists
  • Professionals interested in PK/PD modeling & simulation
  • Health authorities
  • Academic professionals in health science/pharmaceutics

Learning Objectives 

  • Overview of FIH study including study design, selection of starting dose, dose escalation and stopping rule
  • How is the POC normally carried out with precedent/unprecedented mechanism of action (MoA)
  • Importance of proof of pharmacology and utility of novel clinical technology for POC
  • Modelling and simulation for human dose prediction and POC decision-making
  • Safety/risk management in early clinical development

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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