Improve your Regulatory Intelligence (RI) Skills

Detailed programme

Day 1: 12:00 - 16:00
Day 2: 12:00 - 16:00
You may dial in 30 min. before the session

Introduction to regulatory intelligence (RI)

• Defining RI and its key components; skills and competencies
• Where the need for RI in pharmaceutical industry stems from

Short break

Monitoring the regulatory environment

• Main sources for regulatory information in key jurisdictions
• Public information from regulatory authority webpages
• Identifying regulatory trends

Exercise

Short break

Understanding and shaping the regulatory environment

• The role of impact analysis in RI
• Regulatory guidelines and consultation procedures
• Opportunities and forums for engagement with stakeholders

Exercise

End of day one

Locating and analysing regulatory precedent

• Locating and analysing precedent from EU and US drug and biologic sources
• Assessing the impact of precedent for regulatory decision-making
• Understanding the importance and context of precedent in regulatory strategy

Short break

Exercise

Communication and knowledge management in RI

• How to effectively communicate RI within the organisation
• Tools and processes for communication; Knowledge sharing and management

Short break

The strategic value of RI and its evolution

• Increasingly strategic value progressing R&D towards HTA and access
• RI role in support of due diligence activities
• Artificial Intelligence and the next frontiers of RI

Exercise

Seminar end

Detailed programme

Day 1: 12:00 - 16:00
Day 2: 12:00 - 16:00
You may dial in 30 min. before the session

Introduction to regulatory intelligence (RI)

• Defining RI and its key components; skills and competencies
• Where the need for RI in pharmaceutical industry stems from

Short break

Monitoring the regulatory environment

• Main sources for regulatory information in key jurisdictions
• Public information from regulatory authority webpages
• Identifying regulatory trends

Exercise

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