The Drug Development Lifecycle: From Preclinical Studies to Phase IV (EN)
Understand the key stages of the drug development lifecycle, from preclinical evaluation to post-marketing activities. Learn to identify stakeholders, regulatory interactions and strategic challenges associated with clinical development.
- Biopharmaceutique - procédés et qualité
- Seneffe
- 1 day
- 12 people max.
- Céramique Création et Pharma consulting
- Entreprise
- Présentiel, Anglais
Before you register
Target audience : Clinical support functions (e.g., clinical operations, project management, data management, production, lab testing)
Prerequisite : No prerequisites needed
Learning objectives
- 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
Training content
- 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 and ethical context governing clinical development
- Clinical development stakeholders and ecosystem
- Roles and interactions between pharmaceutical companies, regulatory authorities and external partners
- Key prerequisites before First-in-Human (FIH) studies
- Strategic interactions between preclinical and clinical development
- Influence of preclinical data on clinical trial protocols
- 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
Tarifs et aides financières
511 €
Formation catalogue planifiée chez aptaskil, avec un maximum de 25 % du groupe de participants issus d'une même organisation
Formation catalogue réservée à votre équipe, organisée dans vos locaux ou chez aptaskil selon vos préférences
Formation entièrement construite avec vous, adaptée à vos objectifs, votre contexte et vos besoins opérationnels
