Project Scheduling Techniques for Drug Development Submissions if US and EU

Regulatory submissions for drug development require precise project scheduling to meet critical milestones and ensure timely market entry.

This webinar, Project Scheduling Techniques for Drug Development Submissions in US and EU, provides practical insights into structuring submission timelines, managing cross-functional dependencies, and mitigating potential delays. Participants will learn effective scheduling methodologies, such as critical path analysis and phase-gate planning, and explore digital tools that enhance efficiency. Whether navigating IND, NDA, BLA, or EMA submission pathways, attendees will gain the strategies needed to optimize regulatory timelines and streamline the approval process.

Why You Should Attend:
Participants in this webinar will acquire essential knowledge on planning and managing drug development submission schedules to ensure timely regulatory approvals.

By understanding FDA and EMA timelines, utilizing effective scheduling methodologies, and implementing risk management strategies, attendees will enhance their ability to navigate complex submission processes. This training is designed to improve efficiency, minimize delays, and enhance collaboration across regulatory, clinical, and project management functions, ultimately supporting successful drug development initiatives.

Areas Covered in the Session:

• Introduction to Project Scheduling in Drug Development (5 minutes)
• Importance of structured project scheduling for regulatory submissions
• Overview of US FDA and EU EMA submission pathways
• Objectives of the webinar
• Regulatory Timelines and Submission Requirements (10 minutes)
• Key US FDA submission pathways (IND, NDA, BLA, ANDA) and timelines
• EMA submission processes (MAA, centralized, decentralized, and national procedures)
• Understanding key milestones and interdependencies
• Project Scheduling Techniques for Drug Development (10 minutes)
• Gantt charts, critical path method (CPM), and PERT analysis
• Phase-gate planning and iterative scheduling approaches
• Best practices for aligning R&D, clinical, and regulatory teams
• Managing Risks and Avoiding Delays in Submission Timelines (10 minutes)
• Identifying potential bottlenecks in regulatory processes
• Risk-based scheduling and contingency planning
• Case studies of successful and delayed submissions
• Tools and Technologies for Submission Planning (10 minutes)
• Project management software (MS Project, Smartsheet, Planisware, etc.)
• Digital collaboration tools for cross-functional teams
• AI-driven predictive scheduling and automation
• Case Studies and Practical Applications (10 minutes)
• Real-world examples of drug development submission schedules
• Lessons learned from timeline accelerations and delays
• Strategies for optimizing project scheduling efficiency

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