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
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
Fonds de formation du secteur chimie, plastiques et sciences de la vie qui finance les formations des collaborateurs des CP 116 et 207
Fonds de formation du secteur agroalimentaire qui finance les formations des collaborateurs des CP 118 et 220
Cette formation vous intéresse ?
La formation n'est actuellement pas programmée en inter-entreprise. Si vous souhaitez vous former vous ou vos collaborateurs, notre équipe peut organiser cette formation en intra-entreprise ou l'adapter à vos besoins spécifiques.
