Description: Regulatory professionals sit at a powerful intersection between critical actors and stakeholders required to bring a profitable drug to market. Regulatory professionals have to manage communications and timelines across internal and external actors, set appropriate expectations for all involved, and manage key regulatory gates with a panoply of global actors (FDA, EMA, PMDA, among others). The regulatory professional role can be seen as tactical, operational and as a functional staff utility for a pharmaceutical/medical device company; or, the role can be highly strategic, and influential in drug/device development planning, presentation and submissions. This workshop aims to teach or refresh key principles in strategy, and provide practical guidance on how to incorporate strategic thinking in the regulatory role, as well as to engage internal partners to work together with a strategic, collaborative mindset. As well, the workshop will cover some key ideas around organizational functioning and culture that can affect how strategic thinking is realized (or not). Live surveys will help identify action issues for afternoon discussion.
Share key principles of strategic thinking, innovation, and design thinking – build/extend the language system for discussing innovation, strategic thinking and systems change
Assess current regulatory affairs practices, culture, and behavior and contrast with ideals for innovation and strategic thinking, with specific application to current change management challenges
Identify opportunities to experiment, innovate, think long term, try new practices in home workplace
Build action plan for innovation experiments/action learning