CRED 8 Presentations

01/07/2024

Organising your Company

• Prepare for different scenarios • Who would you take to an OE? Who would attend a clarification meeting? Do you need KoL support? • Ensure senior leadership and other key stakeholders (e.g. Commercial, Supply Chain) are kept informed of key milestones and know when to escalate issues • Prepare to receive lots of internal questions • Plan in advance of questions, and be on standby in case of ad-hoc requests • Use tools to track questions and responses, ensure team is clear on process, set up placeholder meetings to assess questions etc • Be agile when needed; have a rapid response team available for any questions that require quick answer (CRITICAL for accelerated assessment) • Have regular meetings with core team (and wider) to keep on track, escalate challenges and ensure consistency of response

The Organisation for Professionals in Regulatory Affairs

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Further info to come in theory vs reality

Common Problems and Pitfalls

• Not using regulatory interactions effectively • Not knowing business priorities and global strategy • Not having enough resource; filing an MAA requires a dedicated team • Under-estimating time required to author documents and responses • Under-communicating to internal teams • Making assumptions • Not following guidance, this can lead to unnecessary questions and even major objections • Insufficient risk mitigation • Not being transparent e.g. if issue in data calculation, tell the Agency! • Not communicating effectively with EMA Product Lead and leveraging relationship • Not thinking creatively and looking for solutions when responding • Assessment reports will often be late, and there may be errors (we’re all human!)

The Organisation for Professionals in Regulatory Affairs

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