Drug Development and Pharmaceutical R&D Business Framework

Drug Development and Pharmaceutical R&D Business Framework, available at $49.99, has an average rating of 3.91, with 30 lectures, 5 quizzes, based on 102 reviews, and has 431 subscribers.

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

Enroll now: Drug Development and Pharmaceutical R&D Business Framework

Summary

Title: Drug Development and Pharmaceutical R&D Business Framework

Price: $49.99

Average Rating: 3.91

Number of Lectures: 30

Number of Quizzes: 5

Number of Published Lectures: 30

Number of Published Quizzes: 5

Number of Curriculum Items: 35

Number of Published Curriculum Objects: 35

Original Price: €109.99

Quality Status: approved

Status: Live

What You Will 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

Who Should Attend

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

Target Audiences

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

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 Curriculum

Chapter 1: Introduction to Drug Discovery & Development

Lecture 1: Introduction

Lecture 2: Drug Development in a Nutshell

Lecture 3: Drug Discovery

Lecture 4: The R&D Pipeline & Portfolio Management: An Introduction

Chapter 2: Development Phases (Highlights)

Lecture 1: Pre-Clinical (Phase 0)

Lecture 2: What are Clinical Trials?

Lecture 3: Phase I

Lecture 4: Phase II

Lecture 5: Phase III

Lecture 6: Registration & Launch

Lecture 7: Phase IV (Post-Launch)

Chapter 3: The R&D organisation

Lecture 1: The R&D Organisation

Lecture 2: The CMC Function

Lecture 3: The Clinical Function

Lecture 4: The Non-Clinical Safety Function

Lecture 5: The Regulatory Affairs Function

Lecture 6: Project Management Functions

Chapter 4: Project Management Framework and Governance

Lecture 1: The Project Team

Lecture 2: Project Management Framework

Lecture 3: Global Drug Development Plan & The Target Product Profile (TPP)

Lecture 4: Project Milestones: Overview of milestone types and Phase Milestones

Lecture 5: Project Deliverables

Lecture 6: Project Decision Points and Project Governance

Chapter 5: Information Systems, Numericals and Reporting

Lecture 1: IT Landscape and Information Flow

Lecture 2: Project Reporting

Lecture 3: Function Reporting

Lecture 4: Portfolio Reporting, Performance Indicators and Benchmarking

Chapter 6: Conclusion

Lecture 1: Summary of Learnings & The future of pharmaceutical companies

Lecture 2: Course Assets/ Downloads

Lecture 3: Acknowledgements

Instructors

Project Upskill
by Veemal Chungoora

Rating Distribution

1 stars: 2 votes
2 stars: 5 votes
3 stars: 16 votes
4 stars: 36 votes
5 stars: 43 votes

Frequently Asked Questions

How long do I have access to the course materials?

You can view and review the lecture materials indefinitely, like an on-demand channel.

Can I take my courses with me wherever I go?

Definitely! If you have an internet connection, courses on Udemy are available on any device at any time. If you don’t have an internet connection, some instructors also let their students download course lectures. That’s up to the instructor though, so make sure you get on their good side!

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