Structure + Content
Setting
This programme emphasises communication as a critical skill, particularly for regulatory professionals who interact with a global audience, including manufacturers, authorities and Notified Bodies. Communication skills are essential for discussing issues with internal management and effectively navigating due diligence processes.
A strong understanding of statistical methodologies and data interpretation are essential. You will learn the language of statistics, identify the right questions to ask and use the resources available to answer them. Mastering the use of (bio)statistics ensures consistency in documents and clarity in messaging, fostering confidence in your contributions to clinical development.
The integration of Artificial Intelligence (AI) is transforming the regulatory landscape. This programme explores how AI can streamline processes, enhance data analysis and improve decision making. You'll learn how to use AI to automate routine tasks, allowing you to focus on strategic activities and increase productivity. However, the use of AI in healthcare presents challenges such as privacy, ethical considerations and regulatory compliance, which are also covered.
Ethics is the foundation of laws and regulations. This course addresses the ethical challenges faced by regulatory affairs professionals and the importance of ethical practices in clinical trials, product development and regulatory compliance. Linked to ethics is sustainability: You will also learn about environmental management, recycling and waste disposal as well as best practices for sustainability and environmental compliance.
Marketing principles and marketing regulation are also included in this programme.