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 will define best practices for establishing submission timelines that won’t change, address regional differences to minimize document re-work when submitting to multiple countries, and identify leadership and project management skills helpful to regulatory writing.
About Our Speaker
With a career spanning more than 25 years in the pharmaceutical industry, Mr. Sibley has extensive experience across regulatory writing, consulting, and clinical project leadership roles. He has successfully supported projects from discovery through approval and life cycle management. These include significant roles in more than 50 submissions and, in several cases, leading the entire submission team overseeing all documentation from Modules 1 through 5. Mr. Sibley drives the expansion of the company’s submission leadership and consulting capabilities in guiding clients to successful clearance of regulatory milestones.