Project Management

Practical Classes (# 3 – 29th Set 2023)

Prof. Nuno Cavaco Time to clarify doubts: Fridays 12h30 – 14h00

Email: namc@fct.unl.pt Previous booking via email

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Project Management

Learning Outcomes of Class 3

• Example / Exercise of Project Charter

• Group Assignment – Development of the Project Charter

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Project Charter – concept review

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Example / Exercise of Project Charter

• EasyLife is a pharmaceutical industry
• The company has more than 40 years of experience and is
recognized for its innovative capacity
• They goal/ project is to produce a new medicine/drug
• This medicine aims to treat heart attacks

Let´s build up its Project Charter

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Project Management

What dimensions should be covered by the Project Charter?

1. Project title 8. Project constrains
2. Project manager 9. Project assumptions
3. Project sponsor 10. High-level risks
4. Project description 11. Project timeline
5. Scope statement 12. Budget estimation
6. Key stakeholders 13. Approval signatures
7. Project deliverables

The document should have around 3 pages

NOTE – The content presented in this exercise aims to give examples of possible
answers, so it exceeds the 3 pages that the document must have
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1. Project title

Issues to consider:
• Must be objective/succinct
H+ project
• Must be able to portray Development and go-to-market of
Heart Plus,
what the project is the revolutionary medicine for heart attacks
• Must be appealing

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2. Project manager

Issues to consider:
• Skills (technical, leadership and
behavior) Nuno Martins Cavaco
Head of product innovation
• Current role and responsabilities namc@fct.unl.pt
930000001
• Availability (concerning other
projects and its time allocation)
• Overall project planning,
execution, and reporting

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3. Project sponsor

Issues to consider:
Nome Role Scope Contacts
• Who have the power Rui Setas PCA Authorization
rs@easylife.com
930000002
• Who is responsible for Inês Saraiva Financial Dir Funding
is@easylife.com
930000003

• Authorization, funding Alice Luz

Innovation
Support
al@easylife.com
930000005
Council Dir
and support

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4. Project description
Issues to consider:
• What the aims to achieve
• Goals and objectives
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H+ aims to be an innovative medicine for treating heart
attacks.
The project of its development and go-to-market represents
a bold step forward in cardiovascular medicine, with the
potential to save countless lives and alleviate the global
burden of heart disease.
It combines cutting-edge scientific research with a strategic
market approach to bring this life-saving innovation to
those who need it most.
Heart attacks, or myocardial infarctions, are a leading cause
of mortality worldwide.
H+ will be a huge opportunity to reinforce Easylife’s
competitive position in the market and for its sales and
revenue increase, estimated around 1,5 BUSD/year after
the second year in the market.
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4. Project description

Objectives 1. Life-Saving Medication: The H + project aims to provide a medication that

can significantly reduce mortality and morbidity associated with heart
attacks.
2. Improved Quality of Life: By minimizing cardiac damage and preventing
recurrent heart attacks, the medicine will enhance the quality of life for
heart attack survivors.
3. Economic Benefits: Reduced healthcare costs related to heart attack
treatment and hospitalization, along with improved productivity among
survivors, will contribute to economic benefits. Increasing Easylife’s
revenue around 1,5 BUSD/ year
4. Global Impact: The project aspires to have a global impact by addressing
a widespread health issue and improving healthcare outcomes on a broad
scale. Will reinforce Easylife’s competitive position in the market
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5. Scope statement (3/3) 1. Medicine Development:

1. Conduct comprehensive research to formulate and develop an innovative
Issues to consider: pharmaceutical solution for the treatment of heart attacks.
2. Design the medicine to provide rapid symptom relief, minimize cardiac
• What is included muscle damage, and prevent recurrent heart attacks.
2. Clinical Trials:
1. Plan and execute rigorous clinical trials to assess the safety and efficacy of
the developed medicine.
2. Include diverse patient populations to evaluate the medicine's
performance under varying conditions.
3. Regulatory Approvals:
1. Work closely with regulatory authorities to obtain all necessary approvals
for the distribution and usage of the medication.
2. Ensure compliance with local and international regulations and standards.
4. Manufacturing and Quality Control:
1. Establish robust manufacturing processes and quality control protocols to
ensure consistent production of the medication.
2. Implement stringent quality assurance measures to meet safety and
efficacy standards.
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5. Scope statement (3/3)

Issues to consider:
5. Go-to-Market Strategy:
1. Develop a comprehensive market entry strategy, including pricing,
• What is included
distribution channels, and marketing campaigns.
2. Identify target markets and customer segments.

6. Education and Awareness:

1. Implement initiatives to educate healthcare professionals, patients,
and the public about the advantages and proper use of the new
medication.
2. Raise awareness about heart attack prevention and management.

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5. Scope statement (3/3)

Issues to consider:
• What is excluded 1. The project does not include the development of medical
devices or surgical procedures for heart attack treatment.

2. Marketing and distribution activities beyond the initial market

launch are not within the scope of this project.

3. While the project aims to enhance heart attack prevention, it

does not encompass the development of preventive vaccines
or lifestyle interventions.

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6. Key stakeholders

Issues to consider:
• Who have an interest
in the project
• Who are likely to be
impacted by it
• Internal and external
stakeholders
• Importance-influence
matrix

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6. Key stakeholders
• Primary Stakeholders:
Issues to consider: • Patients and their families
• Healthcare providers (doctors, nurses, paramedics)
• Who have an interest • Pharmaceutical researchers and developers
• Regulatory authorities (FDA, EMA, etc.)
in the project • Investors and funding partners
• Marketing and distribution teams
• Who are likely to be
impacted by it • Secondary Stakeholders:
• Pharmaceutical manufacturing facilities
• Internal and external • Hospitals and healthcare institutions
stakeholders • Medical associations and organizations
• Government health agencies
• Importance-influence
matrix Let’s do the importance-influence matrix
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7. Project deliverables

Issues to consider: 1. Formulated and tested medication for heart attack

treatment.
• Tangible and
2. Clinical trial reports and regulatory approvals.
intangible products,
services, or 3. Established manufacturing processes and quality control
protocols.
outcomes
4. Go-to-market strategy and marketing materials.

5. Educational materials for healthcare professionals and

the public.

6. Market launch and initial sales.

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8. Project constrains

Issues to consider:
• Budget: The project is subject to budget limitations and
• Issues that may limit the will seek funding from various sources, which may
project's options or impact the pace and scale of development.
influence its outcome
• Regulatory Hurdles: Compliance with regulatory
• Budgetary limits, time requirements and approvals may introduce delays or
modifications to the project timeline.
constraints, regulatory
requirements, and • Market Competition: The pharmaceutical market for
heart attack treatment is competitive, and market
resource limitations dynamics may affect market penetration and pricing
strategies.

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9. Project assumptions

Issues to consider: 1. The project assumes the availability of skilled and

• Environment or qualified researchers, clinicians, and pharmaceutical
experts.
conditions that could
affect the project's
success 2. It is assumed that the medication development
process will proceed according to the current state of
scientific knowledge and technological capabilities as
of the project initiation date.

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10. High-level risks 1. Clinical Trial Challenges:

1. Patient Recruitment: Difficulty in recruiting a sufficiently
Issues to consider: diverse and representative patient population for clinical trials
can lead to biased results. Establish protocols with hospitals
2. Safety Concerns: Unforeseen adverse effects or safety issues
• Potential risks and during clinical trials may result in delays or even project
uncertainties termination. Identify side-effects at research activity

• Initial strategies for 2. Regulatory Hurdles:

1. Regulatory Approval Delays: Regulatory agencies may require
risk mitigation additional data or documentation, causing delays in obtaining
approvals. Anticipate needs & establish relationship
2. Compliance: Ensuring strict compliance with evolving
regulatory standards and requirements can be challenging and
may necessitate changes to the drug's development.

3. Scientific Uncertainty:
1. Efficacy and Safety: The medicine's effectiveness and long-term
safety may not meet expectations, leading to significant
setbacks in development or market acceptance.
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10. High-level risks 4. Competitive Landscape:

1. Market Competition: Other pharmaceutical companies may
Issues to consider: develop competing drugs, affecting market share, pricing, and
market penetration.
2. Intellectual Property: Protecting intellectual property and
• Potential risks and defending against patent challenges is crucial to maintaining a
uncertainties competitive edge.

• Initial strategies for 5. Funding and Budget Constraints:

1. Insufficient Funding: Budget limitations or difficulties in
risk mitigation securing funding may impede research, development, and
marketing efforts.
2. Cost Overruns: Unanticipated expenses in clinical trials,
manufacturing, or regulatory compliance can strain the
project's budget.

6. Supply Chain Disruptions:

1. Manufacturing Issues: Problems in scaling up manufacturing
processes or securing the necessary raw materials may disrupt
the drug's production and distribution.
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10. High-level risks 7. Market Acceptance:

1. Market Skepticism: Healthcare professionals and patients may
Issues to consider: be skeptical of a new medication, leading to slower adoption.
2. Pricing Challenges: Finding the right pricing strategy to balance
affordability and profitability can be challenging.
• Potential risks and
uncertainties 8. Ethical and Legal Concerns:
1. Ethical Issues: Ethical dilemmas may arise concerning patient
• Initial strategies for consent, access to the medication, and clinical trial conduct.
2. Legal Challenges: Legal disputes, including patent litigation and
risk mitigation regulatory issues, can lead to costly delays and setbacks.

9. Healthcare System Integration:

1. Integration Challenges: Ensuring the medication is seamlessly
integrated into healthcare systems and protocols may require
significant effort.

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10. High-level risks 11. Market Volatility and Economic Factors:

1. Economic Downturn: Economic recessions or downturns can
Issues to consider: impact healthcare spending and market demand for new
medications.
2. Currency Fluctuations: Exchange rate fluctuations can affect
• Potential risks and the cost of manufacturing and international pricing.
uncertainties
12. Pandemic or Health Crisis:
• Initial strategies for 1. Public Health Emergencies: Outbreaks of infectious diseases or
other public health crises may divert resources, attention, and
risk mitigation funding away from the project.

13. Reputation Risks:

1. Negative Media Coverage: Unforeseen issues or adverse events
related to the medication can lead to negative media coverage
and damage the project's reputation

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11. Project timeline

Issues to consider: The H + project anticipates a multi-year timeline

encompassing research, development, clinical trials,
• Main activities and durations regulatory processes, manufacturing setup, and
market launch. The estimated duration of the project
• Relation between activities is 43 months.

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12. Budget estimation The project will require significant funding to cover research,
development, clinical trials, manufacturing facilities, and
Issues to consider: marketing.

• Initial estimate budget Funding will be sought from public and private sources,
including venture capital, grants, and partnerships.
• Funding requirements
Investment
• Financial assumptions
Human Resources 1 000 000 €
Equipment 6 000 000 €
Materials 3 000 000 €
Clinical trials 5 000 000 €
Administrative processes 2 000 000 €
Marketing 1 500 000 €

Total 18 500 000 €

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13. Approval signatures

Issues to consider:
Nome Role Scope Contacts
• By the project sponsor Rui Setas PCA Authorization
rs@easylife.com
930000002
• Other key stakeholders Inês Saraiva Financial Dir Funding
is@easylife.com
930000003
Innovation al@easylife.com
Alice Luz Support 930000005
Council Dir

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Let’s do the Project Charter of our project (group work assignment)

You can use the templates on CLIP

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