pharmaceutical drug development

Introduction to Business Operations in Drug Development & Clinical Research Process


$ 100 /Course


What you'll learn

  • Know what are core activities carried out in each phase of the project and their importance
  • Understand the roles and responsibilities of different business functions in the drug development process
  • Understand core strategic and project management aspects of business operations in the development of a drug in medium and large biopharmaceutical companies
  • Understand the terminology used in the drug development project lifecycle
  • Understand the business platforms and tools used to drive and support drug development projects


  • Primarily you have an open mind and the will to learn
  • It is an advantage if you have you have a background in life science or business.
  • It is an advantage if you have a strong business acumen and are able to understand business processes and project management concepts as well as workflows or processes
  • Last but not least, some technical understanding of business technology applications or software used to support business operations are an asset for this course


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

Who this course is for?

  • Anybody new to the pharmaceutical sector especially R&D and who would like to work in this sector
  • People who need a fundamental knowledge on drug development for their job (e.g. IT company which are providers for pharma firms)
  • Graduate and Undergraduate students, (in biotechnology, life sciences, pharmacy and related pharmaceutical domains), whose institutions do not offer courses like this one
  • This course is NOT for seasoned professionals in pharmaceutical development

Course content

6 sections • 30 lectures • 1h 4m total length


Karen Kiranka

Pharmacist, MBA in HealthCare Management

Karen Kiranka, is a trained health systems manager with an MBA in Healthcare Management from Strathmore University Business School. She has a background in Pharmacy and Public health. Karen is involved in the day-to-day operations at CRK-Clinical Research Organization and works as a lead researcher in the clinical trials, all the other market research, and training.

Karen is registered with the Pharmacy and Poisons Board and the Health Systems Management Association. She is rich with leadership skills, critical thinking, communication skills, and a great team player. She has worked with key leaders in the health industry including The Nairobi Hospital, Avenue HealthCare, and Pink Pharmaceuticals Limited.


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