Regulatory strategy in product development (micro-credential)

Micro-credential (2 ECTS)

Course objectives

• 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.

Audience

Professionals involved in drug development areas such as regulatory affairs, manufacturing, preclinical and clinical development, clinical operations, medical marketing, market access, or quality assurance and quality control within the pharmaceutical, biotechnology, or medical device industries. This may include regulatory affairs specialists, project managers/leaders, entrepreneurs, clinical scientists, and professionals contributing to the development and registration of therapeutic products.

Registration deadline

20 March 2026