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Wednesday, June 22 • 9:00am - 10:00am
#306: Leveraging Best Practices and Tools from the Discipline of Project Management to Uphold Quality, Protect Patient Safety, and Optimize Financial Budgets in a World of Complexities

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Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-22-600-L04-P ; CME 1.00; PDU 1.00 PMI 216632V6LJ; RN 1.00

The biopharma project manager needs to be well equipped to properly manage both anticipated and unanticipated uncertainties and changes across the drug development phases. Uncertainty can be brought on by complex business ventures like mergers and acquisitions, the evolving landscape of the COVID-19 pandemic, and the evolving global clinical research landscape. Whether internally or externally triggered, changes may impact financial incentives and quality management plans. The importance of quality, patient safety, and financial precision throughout the drug product development continuum is unquestionable and the efforts to uphold rigorous standards are further complicated by the challenge of remote work. To limit disruption or risk caused by change, the well-positioned project manager drives the quality management processes, put into place a plan for continual improvement and leverages benchmark data to uphold standards. For example, understanding Fair Market Value data when it comes to the development of negotiating a tight budget is a key component to the global clinical research landscape. The global effect of industry is changing with the steady rise of mergers, acquisitions, and strategic alliances. The resulting relationships trigger the need for effective pharmacovigilance integration strategies to ensure compliance while protecting patient safety. In this session, we will share best practices that may be applied to uncertain circumstances to prioritize the wellbeing of patients, uphold quality standards and identify opportunities for economic data and technology to deliver efficacy. A project manager can use his/her specialized skills, tools, and techniques to find innovative ways to help organizations achieve desired outcomes despite uncertainty. The project manager, like the conductor of an orchestra, plays a critical role aligning and leading a project team to success.

Learning Objectives

Recognize the potential impact of mergers, acquisitions, and strategic alliances on patient safety; Identify strategic, actionable factors for successful pharmacovigilance transitions; Discuss the importance of quality management in drug development projects; Describe how a robust quality management plan can be developed and utilized during uncertain times; Demonstrate the manual, time-consuming processes associated with building and negotiating a clinical trial budget and the impact.


Sabrina Hayden, PharmD


Optimizing Study Budgeting and Access to Industry Indicative FMV Data to Accelerate Trial Timelines
Ashley Baxter

Protecting Patient Safety in an Age of Pervasive Mergers, Acquisitions, and Strategic Alliances
Sabrina Hayden, PharmD

Quality Management During Uncertain Times: The Evolving Role of Project Manager
Vinod Arora, MSc

avatar for Vinod Arora

Vinod Arora

Lead- Portfolio Management, Bridge Medical Consulting Pvt. Ltd, India
Vinod has over 18 years of experience spanning project management, medical writing, quality control, and people development. He has played an active role in strategic initiatives for project management, process improvement and people development during his journey in pharmaceutical... Read More →
avatar for Ashley Baxter

Ashley Baxter

Sr. Business Optimization Specialist, Greenphire, United States
Ashley Baxter is an innovative solutions provider with more than a decade of experience working on studies from the bidding stage, all the way through study closeout. Her roles have ranged from regulatory documents, site contracts, payments, proposals, operational bidding, start-up... Read More →
avatar for Sabrina Hayden

Sabrina Hayden

Pharmacovigilance Fellow, Albany College of Pharmacy, BeiGene, Inc., United States
Graduated from Massachusetts College of Pharmacy and Health Sciences located in Boston, MA with a PharmD and is currently enrolled in the university's Master of Business Administration courses specifically in Healthcare Management. Offered a pharmacovigilance fellowship with Albany... Read More →

Wednesday June 22, 2022 9:00am - 10:00am CDT
Room 183 C McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616
  07: ProjectManagement-StrategicPlanning, Session