Overview

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 CourseThis 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 JoinTo improve the understanding of the essential steps in drug development process with focus on the development stagesUnderstand the business and operational aspects of managing drug development projectsUnderstand the responsibilities of R & D functions' and project teams along the drug development processLearning ObjectivesBy the end of this course, you will:Get a solid foundation in the drug development process and who are major actors in a biopharma companyIdentify 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 projectKey Take AwaysDrug Development phases from discovery, through clinical development to submissionClinical Development: general principles of clinical trials and phase specificitiesThe Global Drug Development Plan and the Target Product Profile (TPP) and their importanceRoles 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, governanceTarget AudienceProfessionals new to drug development and clinical research Scientific and non-scientific employee eager to better understand business and operational aspects of driving drug development projectsAnybody interested in learning more about the drug development process

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