Drug Development and Pharmaceutical R&D Business Framework

Introduction to Business Operations in Drug Development & Clinical Research Process

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Drug Development and Pharmaceutical R&D Business Framework

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

Description

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 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

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