Management of Clinical Trials – Regulatory Strategy and Procedures in Product Development

• Understand the roles and responsibilities of major regulatory agencies involved in product development and approval. 
• Gain insight into the international regulatory environment, with a focus on EU, Swiss, and US legislation. 
• Explore regulatory pathways for early access to innovative therapies. 
• Learn about regulatory considerations for special populations, including orphan and paediatric indications. 
• Examine the specificities of advanced therapy medicinal products (ATMPs). 
• Understand the structure and purpose of the Common Technical Document (CTD) in regulatory submissions. 
• Review the regulatory requirements and strategies for the development of generics and biosimilars. 
• Develop strategies for effective interactions with health authorities throughout the product lifecycle. 

• Ability to navigate and interpret international regulatory frameworks applicable to product development. 
• Gain Knowledge of specific regulatory pathways for early access, orphan drugs, paediatrics, and ATMPs. 
• Understanding of the essential aspects of preparation and structuring of regulatory submissions using the Common Technical Document format. 
• Understanding the differences in the development and approval processes for generics and biosimilars vs innovative drugs. 
• Gain expertise in designing and adapting regulatory strategies across product development phases. 
• Understand the planning and managing process for interactions with health authorities to support product approval and lifecycle management. 

CHF 1,800

a) Holders of a university master's degree or doctorate in science, medicine or pharmacy or a qualification deemed equivalent;
or a bachelor's degree in nursing from a Swiss University of Applied Sciences;
or a qualification deemed equivalent or professional experience deemed equivalent by the programme directors.

b) Good oral and written comprehension of English (equivalent to level B2-C1)