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

35

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

36