Agreeing to Submission Document Timelines & Sticking to Them: Fairy Tale or Reality?

Setting and adhering to a timeline for planning, drafting, reviewing and editing regulatory documents needed for the submission dossier is a major challenge for drug development teams. The most common pitfalls in submission planning include:

  • Missing the opportunity to learn and discuss everything possible at the beginning
  • Scheduling summary document preparation in parallel with source document preparation
  • Not engaging all stakeholders in developing the submission

Keeping submission timelines on track can be further compounded when sponsors try to develop simultaneous global submissions. The consequences of a chaotic submission process include wasted time and money, employee burnout, and a suboptimal dossier.

How can teams facilitate the submission process?

In this webinar, Mr. Steve Sibley defined best practices for establishing submission timelines that won’t change, addressed regional differences to minimize document re-work when submitting to multiple countries, and identified leadership and project management skills helpful to regulatory writing.