Overview

The regulatory environment is constantly changing with new science, new unmet needs, new technical advances. Mastering intelligence skills is critical for any full-rounded regulatory professional and is vital part of the skills for any R&D professional. Join the only course in regulatory intelligence that is tailored to the European healthcare landscape with a focus on the key stakeholders like the European Medicine Agency (EMA) and the European Commission.

Exchange experiences, challenges, and solutions with representatives from global pharma organizations but also small or medium companies. The DIA offers an unparalleled network of regulatory intelligence experts. The course will be led 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?

Who should attend?

Professionals that are interested in developing regulatory intelligence skills and possibly specializing in that field are provided with a comprehensive and focused teaching experience. The goal is to master regulatory intelligence as described in DIA’s definition of the term 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.”

Learning objectives

Get an overview of key aspects of regulatory intelligence with hands-on knowledge.
Learn how to gather the right information and understand the impact on your organization.

This training course provides you hands-on experience in:

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

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