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Organiser: DIA

Join the only course in regulatory intelligence that is tailored to the European healthcare landscape with a focus on the key stakeholders like EMA and EC.

This virtual live training course provides 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 course provides 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.

Featured topics

  • Mission, organisation and value of the Regulatory Intelligence function in a pharmaceutical company
  • Overview of the various sources/types of information and different ways to collect it (Push vs. Pull models)
  • Collaboration between corporate RI function and local stakeholders
  • Assessment of the relevance
  • Time-sensitivity and impact of information on the company’s processes and business
  • Interactive session on practical case studies (point of view of several RI professionals on key topics)
  • Analysis of the strengths and weaknesses of the different media available for dissemination of the information (Newsletters, Intranets, Social media…)
  • Discussion on how to store curated information and how to integrate Hard Intelligence and in-house Soft Intelligence
  • Regulatory data analytics: Can technology take it one step forward?

Learning Objectives:

  • Identifying the most reliable and valuable sources of information
  • Monitoring selected sources
  • Assessing the impact of new requirements on your business
  • Communicating key intelligence to internal stakeholders
  • Saving time and resources with the right sources and strategies
  • Understanding the strategic value of regulatory intelligence
Available Dates

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