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Early Pre-Clinical Stage Drug Development From Inception to First Regulatory Submission

This course will teach you to master:

• Pre-Clinical PM Roles
• Building Pre-Clinical Team Requirements
• Matrix and 360-Degree Management
• Change Control Process Implementation
• Comprehensive Risk Mitigation Plan
• Developing a Gap Analysis Plan
• Initial Regulatory Submission Plan
• Creating RACI Diagrams
• Product Profiles and Draft Labels
• Third Party Contractors
• Strategic Partner/SME Relationships
• Cultural and Remote Issues
• Preparing for Regulatory Filing

For the Drug Development Professional: A Two-Day Workshop To Enable More Successful Development Teams

With the inherent risks associated with early stage life-science development, organizations such as yours face a multitude of challenges. Managing product development with challenging and changing technologies can be high hurdles when trying to advance a project into clinical development.

Project success is vital to your stakeholders and the survival of your business. Good project management can provide a strategic and competitive advantage. Great project management techniques can greatly improve the odds of success amid the high stakes struggle to commercialize products.

This first ever Concept to Clinic: Pre-Clinical Project Management workshop will interactively engage you and immerse you in critical essential skills. You will learn the best practices of project management to assess, modify, deliver and review complex early stage projects, and lead your effort to the initiation of a clinical study. The workshop will focus specifically on the earliest stages of bio-product development and drill down into the nature and discipline of managing early stage projects.

Project Management Techniques That Meet the Needs and Demands of the Competitive Pre-Clinical Environment:

Step by step, you will explore the issues that affect your responsibilities and tasks in the competitive drug development field. As a manager or as a team member, with expert guidance from an industry expert, you will hone your skills and learn to...

• Better and more effectively lead the project team, including remote team members
• Develop a comprehensive project plan with preset milestones and inputs for requisite functional areas, key timeline initiatives, key milestones and deliverables
• Develop thorough documentation and planning techniques — allowing for accurate product profiles, draft labels, a comprehensive gap analysis plan and all processes through First Regulatory Submission
• Implement a communications and management plan for a diverse and remote project group or resources
• Manage relationships, conflict and management issues inherent in drug development and life sciences
• Student Needs Assessment Workshop – A customized workshop will be developed and conducted based on the specific needs and issues of the professionals attending this program

Immediate Benefits of Participating In This Workshop

1. Learn to gather only the essential information to build requirements that meet the needs of the pre-clinical team
2. Develop solid drug plans with the end in mind: transition to the preparation for the clinical stage of development
3. Discover new techniques, tips and tricks for effectively managing cross-functional teams
4. Balance the constraints of pre-clinical development including scope, schedule, budget, resources and risk by understanding and using the knowledge areas within the PMBOK©
5. Know how to accurately track, report and resolve technical and team issues with confidence
6. Develop a model to proactively evaluate all pre-clinical project activities
7. Understand how to build contingency plans and execute corrective actions
8. Institute a communication plan that provides only necessary information to all project stakeholders
9. Learn effective planning techniques to develop comprehensive risk mitigation plans
10. Immediately employ effective tools to maximize efficiencies, deliver on targets and milestones, while demonstrating the strategic advantage of the project management function
11. Overcome common challenges that are truly germane within the Pre-Clinical Project Managers tasks
12. Thoroughly prepare the entire team for the First Regulatory Submission
13. Confidently lead your team in developing an initial product label and target profile document
14. Gain knowledge from an expert who has been in the trenches in pre-clinical drug development and willing to share his “lessons learned”
15. Understand the subtle and more obvious nuances associated with third party contractors and work with them to your advantage
16. Discover communication tactics that will create cohesion and unity, preventing costly miscommunication
17. Create much more accurate estimates and schedules, saving time and money
18. Develop RACI diagrams for projects to track roles and responsibilities
19. Effectively work with your team to develop the product profile and characteristics needed for the First Regulatory Submission
20. Discover simple cost-saving and time-saving techniques that will not hinder progress or accuracy as they help you thoroughly bring your projects to completion
21. Learn the tips and tricks that will better serve you in your tasks and your career
22. Balance the constraints of drug development, managing team members and delivering projects to your organization
23. Manage team members across the street or around the world while also understanding cultural differences
24. Effectively integrate strategic partners and outside subject matter experts into your pre-clinical project
25. Track large, complex development projects by better measuring key indicators