Overview
This virtual live training course intends to provide an overview of key aspects of regulatory intelligence. Participants will have a hands-on experience in identifying the most reliable and valuable sources of information, monitoring selected sources, assessing the impact of new requirements on the company’s business and adapting the way of communicating key intelligence to the needs of internal stakeholders.
Regulatory Intelligence has been defined by DIA as “the act of gathering and analyzing publicly available regulatory information (…) including communicating the implications of the information, and monitoring the current regulatory environment for opportunities to shape future regulations, guidance, policy, and legislation.” These aspects are more important than ever to keep track of the global regulatory environment that is constantly changing with new science, new unmet needs new technical advances (e.g. Artificial Intelligence). Mastering intelligence skills is critical for any full-rounded regulatory professional and is part of needed skills that make an R&D professional proficient.
This tutorial intends to provide a comprehensive and focused teaching experience to professionals that are interested in developing regulatory intelligence skills and possibly even specializing in that field. It will focus on the EU environment and its key stakeholders such as the EMA and the European Commission and will explore the sources and types of available information that can support regulatory strategies and wider R&D discussions. It will be hosted by the EU Regulatory Intelligence Network Group (EU RING), an informal group of industry regulatory intelligence professionals based in Europe with a wealth of experience.
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