Drug Development and Pharmaceutical R&D Business Framework

Introduction to Business Operations in Drug Development & Clinical Research Process

Are you considering a career in the biopharmaceutical industry? Are you a new employee or non-technical person working in Pharmaceutical R&D?

About This Course

This course will provide you with an overview of the whole Drug Development process, from drug discovery to regulatory submission, with insights into team structure, project management framework, governance & reporting.
In essence, the course will provide you with the assets to be familiarised and make you more comfortable working for or with a biopharma company.

Why You Should Join

• To improve the understanding of the essential steps in drug development process with focus on the development stages

• Understand the business and operational aspects of managing drug development projects

• Understand the responsibilities of R&D functions' and project teams along the drug development process

Learning Objectives

By the end of this course, you will:

• Get a solid foundation in the drug development process and who are major actors in a biopharma company

• Identify the essential steps in the drug development process

• Identify the key functions involved in the drug development process

• Recognise the key decision points, phases, workpackages and deliverables in a drug development project

  
  

Key Take Aways

• Drug Development phases from discovery, through clinical development to submission

• Clinical Development : general principles of clinical trials and phase specificities

• The Global Drug Development Plan and the Target Product Profile (TPP) and their importance

• Roles and responsibilities of R&D Functions (Chemistry, Manufacturing, and Controls, Project Management, Regulatory Affairs, Clinical, Non-Clinical Development)

• Project Management framework for modern pharmaceutical development:  Project phases, milestones, governance

Target Audience

• Professionals new to drug development and clinical research

• Scientific and non-scientific employee eager to better understand business and operational aspects of driving drug development projects

• Anybody interested in learning more about the drug development process