CRED 8 Presentations

01/07/2024

Piloting a Project Orbis submission

The Organisation for Professionals in Regulatory Affairs

9

Managing Internal Expectations – Handling multiple procedures in parallel

Consider submission sequencing:  Available resources  Anticipate clashing global procedures

● Responses to RFIs / AHEG / OE / Advisory Committee / labeling negotiations – Avoid simultaneous Oral Explanation in Amsterdam and Advisory Committee in Washington …  Assure internal alignment for prioritizing ● What if a 48-hour ClariFaxcomes in two days before Oral Explanation?

The Organisation for Professionals in Regulatory Affairs

10