The drug development lifecycle: from preclinical studies to phase IV

• Identify the different stages of pharmaceutical product development

• Define the key prerequisites before First-in-Human (FIH) studies and the impact of preclinical data on clinical trial design and post-marketing activities

• Describe the roles of the different stakeholders involved in clinical development, both within and outside drug development companies

• Explain the main challenges and risks associated with the clinical development plan
   

Staff working in clinical support functions, such as clinical operations, project management, data management, production, and laboratory testing.

No specific requirements for participation. 

• Drug development lifecycle and clinical development overview

  • Key stages of pharmaceutical product development from preclinical studies to Phase IV activities 

  • Mission, objectives and key issues of clinical development 

  • Global understanding of the drug development lifecycle and associated risks

• Regulatory, ethical and stakeholder environment

  • Regulatory and ethical context governing clinical development 

  • Clinical development stakeholders and ecosystem 

  • Roles and interactions between pharmaceutical companies, regulatory authorities and external partners

• From preclinical studies to clinical trials

  • Key prerequisites before First-in-Human (FIH) studies 

  • Strategic interactions between preclinical and clinical development 

  • Influence of preclinical data on clinical trial protocols 

• Clinical development challenges and post-marketing activities

  • Challenges and risks associated with the clinical development plan 

  • Interactions between clinical development and post-marketing activities 

  • Long-term perspective on the product lifecycle beyond clinical phases