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Increasing the Efficiency & Probability of Success of Clinical trials

Conducted by: Dr. Yossi Gilgun-Sherki
SKU: 201011
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The single biggest category of spending in innovative R&D is clinical development, and the costs for clinical studies were increased dramatically over the years, but with no proportional rise in the rate of new drug approvals. It is therefore crucial to use various managerial, strategic and scientific methodologies in order to improve the efficiency and probability of success in future...Continue reading

The single biggest category of spending in innovative R&D is clinical development, and the costs for clinical studies were increased dramatically over the years, but with no proportional rise in the rate of new drug approvals.

It is therefore crucial to use various managerial, strategic and scientific methodologies in order to improve the efficiency and probability of success in future clinical studies.

The seminar sheds light on the challenges and opportunities that the innovative drug developers in the pharmaceutical industry are facing, and discuss some of the most useful tools that might contribute to better planning, designing and executing of clinical trials. Implementation of these approaches will lead to speed and success rates enhancement while reducing costs.

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Date:  6 January, 2020
Course location: Kfar Maccabiah, Ramat Gan
Duration: 1-Day Course
Hours: 09:00 - 17:00
Credits: 1
Course Language: עברית

Course price: ₪1,850 + VAT
Early registration is Closed
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Issues to be covered

  • Challenges and opportunities in innovative drug development
  • Pre-clinical planning & design
  • Dose extrapolation from animals to human
  • Starting & escalating doses in First-in-Human studies
  • Clinical trials stages
  • Fundamentals of study design & different clinical design types
  • Strategic planning and clinical development
  • Lessons learned from clinical programs execution
  • Innovative methodologies and technologies in clinical testing

Who should attend

CPM, CTM, Clinical directors and any clinical/ IR&D executive that would like to expand his knowledge in drug/ clinical development.

Benefits to the Participants

  • Acquaintance of the challenges and opportunities in innovative drug development from its early stage until approval
  • Acknowledging the importance of efficient pre-clinical planning in support of human studies
  • Attainment of effective tools for execution and analysis of pre-clinical testing prior moving to the clinic
  • Acquisition of effective dose extrapolation techniques from animals to human and understanding of the calculation behind starting & escalating doses in First-in-Human studies
  • Distinguish between early vs. late-stage clinical trials
  • Recognize different study design types and gaining tools to select the optimal design
  • Comprehend the value of strategic planning and effective clinical development in decision-making
  • Acquaintanceship with innovative methodologies and technologies that will increase efficiency and probability of success of a clinical program

About The Lecturer

Yossi Gilgun-Sherki
Dr. Yossi Gilgun-Sherki, an independent Clinical & Scientific Advisor, has
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