Dynamic and Interactive Training offered by ABS Pharma Projects, LLC

Pre-Clinical Stage Drug Development From Concept to First Regulatory Submission

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…1) - Better and more effectively lead the project team, including remote team members, 2) - Develop a comprehensive project plan with preset milestones and inputs for requisite functional areas, key timeline initiatives, key milestones and deliverables, 3) - 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, 4) - Implement a communications and management plan for a diverse and remote project group or resources, 5) - Manage relationships, conflict and management issues inherent in drug development and life sciences and 6) - 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

Strategic Life Science Project Management: Acceleration to Proof of Concept

To remain competitive, pharmaceutical and biotechnology companies must continually pursue innovative products. With the ever increasing risk of failure and the enormous challenges involved in product development, life science companies developing innovative life science products face extraordinary challenges to deliver their products on time and on budget. What can be done to improve the odds and reach greater project success on delivering achievement according to the constraints defined by the product requirements?

Product success is not only vital for the for the organizations stakeholders, but may also be crucial for the survival of the business. Project management methodologies can provide a strategic and competitive advantage for projects that are of critical importance to life science companies and can afford an organization, as a whole, improvement in the odds of success amide the high stakes struggle to commercialize products.

Partnering for Success: Developing Value through Strong Alliances

It is inevitable that projects that utilize outsourced resources will continue to be a part of strategic product development. Creating successful mutually beneficial alliances, that meet the increasing need for strategic development for both partners, will have profound implications on the success of both companies. An alliance must have a solid base that considers the implications for the customer as well as the alliance partners.

This course will examine the impact of 3^rd party relationships on the overall process and development of projects. The participant will learn both practical as well as tactical strategies to benchmark, monitor and control project progress and success. Using Project Management processes and skills, the challenges inherent with strategic alliance management will be addressed.

Managing and Mitigating Risk in Pharmaceutical Development Projects

We all recognize that risk and uncertainty is an inevitable part of all projects. Do we aggressively plan and prepare to manage and mitigate pharma development risks or do we deny that they will happen? Risk management is generally ignored or certainly addressed only when it happens. What are the potential upsides and downsides of our development projects and how can we initiate a total Risk Management system in our projects? There are many approaches and processes that can be developed for risk evaluation. How do we organize our projects and plan for Project Risk?

The participant will learn both practical as well as tactical strategies to plan, manage and mitigate pharmaceutical development risk and reveal strategies using Project Management processes and skills to address the challenges inherent with Risk Management will be addressed.