Course Information
Registration period
Year-round Recruitment
Course Level
Study Mode
Duration
1 Hour(s) 4 Minute(s)
Language
English
Taught by
Project Upskill
Rating
2 views
Course Overview
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
Course Content
- 6 section(s)
- 30 lecture(s)
- Section 1 Introduction to Drug Discovery & Development
- Section 2 Development Phases (Highlights)
- Section 3 The R&D organisation
- Section 4 Project Management Framework and Governance
- Section 5 Information Systems, Numericals and Reporting
- Section 6 Conclusion
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
Skills covered in this course
Reviews
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PPriyanshu Vaishya
Hyuuuuu
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YYasmeen Nkrumah-Elie
It is a good match. I am having to pause to take notes, as I was not able to find a transcription of the lecture.
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SShivani Bharam
the quiz could be improved..its vry simple
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KK Steele
I have an MBA, but my school did not have a focus on healthcare. I have 20+ years working for or in support of pharma manufacturers, but on the commercial side, not the R&D side. So far this course does a good job of outlining the basics. There's lots I know already, but it moves quickly so it doesn't feel like a waste of my time. And there are several things that were gaps for me--things I didn't know, or didn't understand from the R&D perspective--and this has filled them in for me.
