Pharma Project Management Flashcards
What is pharmaceutical project management?
The discipline of planning, executing, and closing pharma projects to achieve specific objectives efficiently, across time, cost, and scope constraints.
What are the three constraints in the project management ‘Iron Triangle’?
Time, Cost, and Quality (Scope).
What does SMART stand for in project management?
Specific, Measurable, Achievable, Realistic, Timed.
What is a milestone in pharma project management?
A major achievement or deliverable that marks progress within the project.
What is a tollgate?
A decision checkpoint where stakeholders assess whether a project can proceed to the next phase.
What is a Target Product Profile (TPP)?
A strategic blueprint outlining desired characteristics of the final drug product including indication, efficacy, dosage, and administration route.
What are Target Product Claims (TPCs)?
Statements reflecting intended regulatory and marketing claims that shape regulatory strategy and study design.
What is the difference between Proof of Principle (PoP) and Proof of Concept (PoC)?
PoP shows biological activity (non-clinical), PoC demonstrates clinical efficacy (in patients, supports investment decisions).
How does a team differ from a group?
A team shares goals, accountability, and works collaboratively, whereas a group may work independently with no shared purpose.
What are the characteristics of a high-performing team in pharma?
Shared vision, clear roles, diverse expertise, supportive culture, cross-functional coordination, mutual accountability.
Is constructive tension beneficial in pharma teams?
Yes – it drives innovation through diversity of thought and challenges assumptions.
Why is clarity in team structure and roles important in pharma projects?
It ensures accountability, enhances communication, and reduces cross-functional conflicts.
What is a key lesson from case-based pharma project issues?
Early planning and cross-functional communication prevent misalignment between clinical, regulatory, and commercial priorities.
What is the role of governance in pharma project management?
To provide structure for decisions, risk management, stakeholder alignment, and efficient resource allocation.
