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Abstract: When planning an Investigational New Drug (IND) or Clinical Trial Authorization (CTA) submission, navigating FDA, EMA, and other regulations can be challenging and creating scientifically-sound strategies are essential. As submissions expand to multiple countries during later phase trials, greater challenges can arise if not prepared with knowledge of the requirements, proper time management, and defined roles for the team towards approval.
Join us as experts in project management, medical writing, and regulatory operations discuss best practices for a successful submission process from start to finish.
Attendees will learn:
- Efficiencies for multi-country submissions
- Essential steps in pre-submission planning
- Timeline management and potential pitfalls
- How to define roles and responsibilities to avoid delays or confusion
- Structure and content of the submissions at various stages of development
- Navigating the country–specific regulatory requirements
- Post-submission maintenance and responsibilities
Jessica Reed, PhD, Senior Manager, Project and Account Management
Nicole Northrop, PhD, Manager, Regulatory and Medical Writing
Allison Ward, MSA, MSEd, Senior Manager, Regulatory Operations