Pharmacokinetics / Pharmacodynamics MODELLING Concepts and Applications in Drug R & D

  • Real Time Online Delivery – Live Training Sessions
  • Virtual Attendance for 4 Days Training
  • Guided Learning Hours – 16
  • Case Studies, Practical Exercises, Q & A,
  • Pre-Course Access: Intro Session Coupon, Pre-Event Questionnaire, Presentation Slide Deck

Course Overview

This comprehensive and detailed intermediate 4-day online course describes the PK/PD studies from an industrial perspective to achieve a successful regulatory submission. The course is intended for those that do not have a previous background in PK/PD but also for those with experience in PK/PD but wish to get an in-depth training in PK/PD.

The daily 4-hr sessions (among many others): Participation will provide an overview of the above topics including temporal placement throughout the drug R&D program. This will be done without excessive use of mathematics. The course will provide trouble-shooting strategies for all the main studies and will focus on the critical aspect for a smooth conduction, interpretation, and use of PK/PD for the successful selection and registration of New Chemical and Biological Entities. The course will provide the basic concepts and application of Population PK as well as its relevance in drug R&D, Case studies will also be provided.

Trainer’s Profile

Our expert has many years of teaching and training experience in several fields of Translational Sciences. Experience consists in translational approaches for drug discovery and development for successful drug discovery and development. Regulatory pre-clinical development package and early clinical development.

Currently applying translational approaches from drug discovery to development and registration in several therapeutic areas. A member of various international scientific societies and serves on the review board of numerous professional journals. Acts as an external expert evaluator for the European Commission on the 7th Framework Program, Maria Sklodowska-Curie Individual Fellowships, HORIZON 2020, and Innovative Medicine Initiative, and for several other government organizations where our expert evaluates and provides recommendations on applications requesting funding.

Key Takeaways

  • A deeper understanding of the PK/PD studies in drug R&D from an industrial perspective.
  • Insight into the optimal strategies to design and interpret the relevant PK/PD studies.
  • A detailed appreciation of the role of biomarkers in drug R&D and their optimal use for study design and outcome evaluation.
  • A critical and practical overview of the crucial aspects of the first in human study design, conduction, and interpretation including regulatory aspects.
  • How to avoid failure of PK/PD studies conducted either in-house or contracted externally.

Who Should Attend

This course has been specifically designed to address the needs and will be of particular benefit to professionals working in different departments including:

  • Pharmacokinetics
  • Pharmacology
  • Regulatory
  • Medical Affairs
  • Licensing
  • Project Management
  • Outsourcing
  • Pre-clinical Discovery and Development
  • Clinical Research and Development

For participation details contact

Mithun Siddartha

mithun.siddartha@biiworld.com

+1 780 851 7197 (Canada)

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Date

Jul 01 - 04, 2024

Time

13:00 to 17:00 (Central European Time – CET)
3:00 pm - 6:00 pm