It is the middle of 2020. The COVID-19 pandemic which was officially declared in March of 2020 issubsiding in the Western parts of the world as the warmer weather begins; the end may be near
although some are predicting we have yet to see the end as the colder weather will trigger a far worse
catastrophe. The pharmaceutical company (XYZ) you work for is a small company, founded in 2009, that
is still in its infancy years with no product on the market yet. All of the firm’s current projects are in the
research and development phases from pre-clinical to phase 3 clinical trials. This means your company
has no revenues yet nor have experience with post-market approval of regulated products. For now, you
are well financially resourced. The company has been backed by several large venture capitalists that
provided cash for equity, and the recent initial public offering (IPO) of the company’s stock on the
NASDAQ provides significant additional liquidity. Additionally, there are many government grants and
programs that are providing financial support of companies undertaking active research to finding a
vaccine or treatment of COVID-19. Currently, the company has $2B in cash and cash equivalents and the
operating expenses per year is about $400M. Further, the company has access to an additional $1B
credit facility and can raise additional funds through issuing new shares albeit it will decrease the value
per share possibly angering existing shareholders.The expertise of XYZ is in antibodies particularly for
cancer treatments. However, one of your scientists suggests that one of your antibodies that is under
patent protection may yield therapeutic value in COVID-19. If true, you could leverage the existing
government programs, and expedited reviews through the regulatory agencies to have your product on
the market by late 2021 or early 2022. Further, this would be your first post-market approved product,
generate revenues, and possibly spike the stock price up given the catalyst event.The senior leadership of
XYZ has decided to undertake this initiative starting with pre-clinical studies commencing in the
upcoming weeks. You are tasked with:
1: Developing a strategy using the instructions provided in-class(by using module3)(Just here include
Implementation of the strategy do not include Strategic Analysis and Strategy Development just
include Implementation of the strategy)
of Strategy
2: Developing a risk management plan using the instructions provided in class.(By using module5)
Introduction to Strategic
Management – MGMT56906
Module 3
Mani Kang, MBA, MSc, PMP
Course Learnings Outcomes
•
Analyze the effectiveness of a project management strategy as it is applied
throughout the project lifecycle.
•
Analyze internal resources, industry structures, and environmental trends
needed to have informed strategies.
•
Evaluate how project management functions reflect the organizational
mandates and goals, including project success.
•
Critique strategies within the context of a regulated environment that
contribute to and promote health equity and inclusion in diverse
communities.
•
Evaluate associated risks and threats to the success of any given project.
•
Apply risk management practices to support formulating a project or
organization’s strategy for success.
•
Develop solutions to issues leading to successful project management
processes, documents, and project outcomes.
What is strategy?
• Strategy is not…
• A goal
• Operational effectiveness or efficiency alone
• Strategy is…
• The creation of a unique and valuable position
• Making trade-offs i.e., deciding what not to do
• Creating fit amongst the firm’s activities
How do you define strategy?
Porter M, 1996 – Harvard Business Review
What is strategic management?
How organizations develop and maintain their strategies
in the context of the greater environment
• Environment is everything ‘outside’ to the organization
• Environment includes opportunities and threats
End goal is to create value added through
competitive advantage and thrive!
Strategic management involves three pillars…
Strategic
Management
Strategic
Analysis
Strategy
Development
Implementation
of Strategy
We will explore each of these pillars in more detail throughout this module!
Class Discussion:
1. Does your organization have a strategy?
2. How does your organization handle strategic
management? Describe your experiences.
Is my strategy good?
Ask these questions of your strategy:
• Does it add value?
• Does it address the environmental circumstances?
• Does it generate competitive advantage for the business?
• Is it unique?
• Does it make sense?
• Can it be adapted if needed?
• Does the risk-benefit analysis suggest it is worth it?
• Does it deliver the results of your intended purpose?
If you cannot answer any of these questions, you may have to
return to strategic analysis to better understand your situation
Strategic
Management
Strategic
Analysis
Strategy
Development
Implementation
of Strategy
External Analysis
Porter’s 5 Forces
Analyzes an industry for its attractiveness
Porter’s 5 Forces
•
•
•
Generally…
How easily can suppliers
drive up the cost of inputs?
How many suppliers exist
that provide this input?
How much would it cost to
switch to another supplier?
number of suppliers means
https://www.investopedia.com/terms/p/porter.asp
supplier power
Porter’s 5 Forces
•
•
Generally…
number of substitutes means
https://www.investopedia.com/terms/p/porter.asp
What goods or services
can be used in place of the
company’s products or
services?
How readily available are
such substitutes?
threat of substitutes
Porter’s 5 Forces
•
•
•
Generally…
How many buyers exist?
How significant, to the
company, is each buyer?
How much would it cost to
find new buyers or
markets?
number of buyers means
https://www.investopedia.com/terms/p/porter.asp
power of buyers
Porter’s 5 Forces
•
•
•
•
Generally…
barrier to entry means
https://www.investopedia.com/terms/p/porter.asp
How high are the barriers
to entry to enter the
industry?
How much money and time
does it take to enter the
industry?
Are there specialized
resources, personnel
required to enter the
industry?
Is the industry regulated
and how hard is it to
become compliant?
threat of new entrants
Porter’s 5 Forces
•
•
Generally…
number of competitors
https://www.investopedia.com/terms/p/porter.asp
How many competitors
exist in the industry?
Do competitors provide
equivalent products or
services?
industry rivalry
Porter’s 5 Forces
•
•
•
Helps managers
understand the competitive
landscape of a company
and how the company is
positioned within it.
May not work well when
trying to analyze a single
company compared to an
industry.
All five forces are
considered equal when in
reality it is not.
Overall, Porter’s 5 Forces explains how costs, prices and consumer benefits act
https://www.investopedia.com/terms/p/porter.asp
Class Exercise:
Apply the Porter’s 5 Forces framework to the
pharmaceutical industry in North America
PESTEL Analysis
Political
Economic
Sociocultural
Technological
Environmental
Legal
PESTEL Analysis
• Enables analysis of the business environment a firm operates in
• Supports strategic planning & enterprise risk management planning
https://corporatefinanceinstitute.com/resources/knowledge/strategy/pestel-analysis/
PESTEL Analysis
• Generally, related to possible
government (in)actions or
policies
Political
• Possible issues:
• Elections
• Anti-competition issues
• International trade
• Fiscal policy
• Proposed legislation
https://corporatefinanceinstitute.com/resources/knowledge/strategy/pestel-analysis/
PESTEL Analysis
• Generally, related to broader
economy thus financial matters
• Possible issues:
Economic
• Interest rates
• Inflation
• Exchange rates
• Employment rates
https://corporatefinanceinstitute.com/resources/knowledge/strategy/pestel-analysis/
PESTEL Analysis
• Difficult to quantify
• Possible issues:
• Demographics
Social
• Lifestyle trends
• Consumer behavior/attitudes
https://corporatefinanceinstitute.com/resources/knowledge/strategy/pestel-analysis/
PESTEL Analysis
• Related to how technology
changes may impact an industry
or organization
• Possible factors:
Technological • Automation
• Cybersecurity
• Artificial intelligence
https://corporatefinanceinstitute.com/resources/knowledge/strategy/pestel-analysis/
PESTEL Analysis
• Matters related to the
environment
• Possible issues:
Environmental
• Carbon footprint e.g., what is
the environmental impact of
computer-based drug
discovery
• Stewardship of natural
resources
https://corporatefinanceinstitute.com/resources/knowledge/strategy/pestel-analysis/
PESTEL Analysis
• Factors that emerge from the
regulatory environment
• Possible issues:
Legal
• Industry specific regulation
• Licensing/permits
• Protection of intellectual
property
https://corporatefinanceinstitute.com/resources/knowledge/strategy/pestel-analysis/
PESTEL Analysis
• The forces of the 6 domains are interdependent
• Goal is to reduce threats and exploit opportunities
Class Exercise:
Apply the PESTEL analysis to a pharmaceutical company
spearheading the development of COVID-19 vaccines in
2020
Internal Analysis
SWOT
Internal to the firm
External to the firm
Strengths
Weaknesses
Opportunities
Threats
SWOT – Strengths
• What does the organization excel at?
• What separates us from the competition?
• What is your strongest asset(s)?
https://www.investopedia.com/terms/s/swot.asp
SWOT – Weaknesses
• What do we need to improve?
• What are not so good at?
• What is our detractors?
• What is the lowest performing asset(s)/resource(s)?
https://www.investopedia.com/terms/s/swot.asp
SWOT – Opportunities
• Are there emerging trends?
• Is there upcoming changes that we can exploit? e.g., election, policies
• What segments are we not targeting?
Can be guided by your Porter’s 5 Forces & PESTEL!
https://www.investopedia.com/terms/s/swot.asp
SWOT – Threats
• Is there something upcoming that can harm our organization? e.g.,
government changes, rising input costs
• Is competition amongst firms increasing?
• Are there new regulations that is negative to us?
Can be guided by your Porter’s 5 Forces & PESTEL!
https://www.investopedia.com/terms/s/swot.asp
Using your SWOT…
• Can support strategic planning
• Knowing what you are good at, not good at, what opportunities and
threats exist, what can you do to achieve your objective(s)?
https://www.investopedia.com/terms/s/swot.asp
Example of an output from a SWOT
Pharmaceutical company ABC is well-resourced and
has plenty of funds to develop a new drug for diabetes
(strengths). However, there are challenges in retaining
highly productive researchers that are essential for
efficient drug discovery (weakness). The diabetes
market is set to increase significantly and is gaining
increased attention from governments for
reimbursement (opportunities). Many big players are
eyeing this market and will most likely enter soon which
increases competition (threat).
VRIO
https://strategicm
anagementinsight
.com/tools/vrio/
• Assess each resource or
capability through this framework
• Resources and or capabilities
that generate sustained
competitive advantage are your
strengths
• Resources is not limited to
’things’, it can be people too
https://strategicm
anagementinsight
.com/tools/vrio/
• In the context of pharmaceutical
companies…
• Many of the approved
products meet the criteria for
sustained competitive
advantage for the duration of
the patent
• Once the patent expires it is
still valuable but may not be
rare i.e., generics
https://strategicm
anagementinsight
.com/tools/vrio/
Class Exercise:
Apply the SWOT and VRIO to any pharmaceutical
company of your choosing (ideally a large one that is
familiar to the class)
Strategic
Management
Strategic
Analysis
Strategy
Development
Implementation
of Strategy
We did our analysis, now what?
https://strategicmanagementinsight.com/tools/strategic-planning-process/
Creating a strategy
• What is your long-term objective?
• What level of strategy are you creating?
• Business (focus for this course)
• Corporate
• Global
https://strategicmanagementinsight.com/tools/strategic-planning-process/
Creating a strategy
• Bridge your internal/external analysis into one strategy based on the
resources that are available to you
• Make sure to answer, ‘does the strategy achieve my objectives?’ and
‘does the strategy align with the organization’s vision and mission?’
https://strategicmanagementinsight.com/tools/strategic-planning-process/
If you have multiple options for a strategy
Evaluate them using a criteria
• What factors are the most important (weighted)?
• Which option comes out ‘on top’?
• Make sure a reality check is done.
• Does your selected option meet your objective(s), is feasible, and
nothing to impede it e.g., regulations?
Put it all together… Diamond E Framework
https://www.smartsheet.com/strategic-planning-models
Put it all together… Diamond E Framework
Ensures that the strategy fits, is possible, and desired!
https://www.smartsheet.com/strategic-planning-models
Strategic
Management
Strategic
Analysis
Strategy
Development
Implementation
of Strategy
Executing strategies needs clear and detailed
instructions
• Often, instructions to implement business strategies are vague
• Employees may not truly understand how strategies will be formed
https://hbr.org/2000/09/having-trouble-with-your-strategy-then-map-it
Strategy map
• Provide clarity on how everything is linked to the overall objectives of the
strategy
• Provides a visual relationship of the objectives, resources and
relationships
https://hbr.org/2000/09/having-trouble-with-your-strategy-then-map-it
Strategy
map
https://hbr.org/2000/09/having-trouble-with-your-strategy-then-map-it
The map to the destination
• Use the strategy map to guide decisions on areas of focus, investment,
and resource allocation
In conclusion
Strategic Analysis
Internal & external environment
Strategic Development
Evaluate options
Strategy Implementation
Map, allocate resources, manage
Managing Risk in
Pharmaceutical Companies–
MGMT56906
Module 5
Mani Kang, MBA, MSc, PMP
Course Learnings Outcomes
•
Analyze the effectiveness of a project management strategy as it is applied
throughout the project lifecycle.
•
Analyze internal resources, industry structures, and environmental trends needed to
have informed strategies.
•
Evaluate how project management functions reflect the organizational mandates
and goals, including project success.
•
Critique strategies within the context of a regulated environment that contribute to
and promote health equity and inclusion in diverse communities.
•
Evaluate associated risks and threats to the success of any given project.
•
Apply risk management practices to support formulating a project or organization’s
strategy for success.
•
Develop solutions to issues leading to successful project management processes,
documents, and project outcomes.
Monitor risks
Implement
risk
responses
Plan risk
management
It is iterative, thus never
ends until the project
ends
Risks change, your
process doesn’t
Plan risk
responses
Perform
analysis
Identify risk
What can happen if risk management is not a
priority?
• Unsafe products
• Ineffective products
• Loss of business
• Legal consequences
Mollah, A. H., Long, M., & Baseman, H. S. Risk management applications in pharmaceutical and
biopharmaceutical manufacturing. (2013)
Health Canada & risk management
• Guidance exists to support the submission of risk
management plans (RMP)
• RMPs are used to
• Support a life cycle approach to drug vigilance
• Enhance HC’s regulatory assessments
• Support timely access to safe, efficacious and high-quality
drugs
• Support ongoing evaluations
• Align drug vigilance with international practices
https://www.canada.ca/en/health-canada/services/drugs-health-products/reports-publications/medeffectcanada/guidance-document-submission-risk-management-plans-follow-commitments.html
ICH E2E pharmacovigilance planning
• ICH E2E guideline defines to parts to an RMP – safety
specification & pharmacovigilance plan while acknowledging
risk minimization is part of risk management planning
• Health Canada has adopted the ICH E2E guideline
https://www.canada.ca/en/health-canada/services/drugs-health-products/reports-publications/medeffectcanada/guidance-document-submission-risk-management-plans-follow-commitments.html
When is a RMP required to Health Canada?
• Can be part of or not part of a new drug submission
• Submission involving new active substance
• Biologics and subsequent entry biologics
• Radiopharmaceuticals
• Drug returning that was previous withdrawn for safety issues
• Drugs with significant change in indication
• Drugs for Extraordinary Use
• If Health Canada requests one from you
https://www.canada.ca/en/health-canada/services/drugs-health-products/reports-publications/medeffectcanada/guidance-document-submission-risk-management-plans-follow-commitments.html
RMP’s can be requested by Health Canada for generics too!
https://www.canada.ca/en/health-canada/services/drugs-health-products/reports-publications/medeffectcanada/guidance-document-submission-risk-management-plans-follow-commitments.html
Health Canada defines a risk management
plan as
A dynamic standalone document reflecting both emerging
known and unknown safety data (clinical & non-clinical) that
should be updated throughout the drug’s life cycle
It is the responsibility of the sponsor/market authorization
holder to perform the required pharmacovigilance and risk
minimization activities in the approved RMP as well as
updates to the RMP
https://www.canada.ca/en/health-canada/services/drugs-health-products/reports-publications/medeffectcanada/guidance-document-submission-risk-management-plans-follow-commitments.html
Why is risk management important for
pharmaceutical projects?
• Regulatory expectation e.g., Health Canada
• Good business practice; comprehensive risk management
should:
• Improve quality
• Increase efficiency
• Reduce non-value-added efforts
• A means of gathering information needed to make sound
business decisions
Mollah, A. H., Long, M., & Baseman, H. S. Risk management applications in pharmaceutical and
biopharmaceutical manufacturing. (2013)
Risk management in the context of
pharmaceutical projects…
• Focuses heavily on:
• Probability of occurrence of harm
• Severity of the harm should it occur
• Remember, from a business perspective it is not just ‘harms’
aka threats, it is also opportunities (Module 2)
What are some hazards that may arise from
pharmaceutical projects?
Not sterile/contaminated
Incorrect potency
Mislabeled
Ineffective
Inefficient processes
Misuse of products
Lack of product supply
Mollah, A. H., Long, M., & Baseman, H. S. Risk management applications in pharmaceutical and
biopharmaceutical manufacturing. (2013)
There are many more… can
you think of any?
What are some harms that may result in
pharmaceutical projects?
Injury/death for the
patients
There are many more… can
you think of any?
Disruption of product
supply
Mollah, A. H., Long, M., & Baseman, H. S. Risk management applications in pharmaceutical and
biopharmaceutical manufacturing. (2013)
Quality Risk Management
Risk to quality is one aspect of overall risk
• Manufacturing & use of a drug product entails some degree
of risk
• Product quality needs to be maintained throughout the
product’s lifecycle
• Effective quality risk management enables better decision
making, proactive ways to identify and control, ensure the
drug’s effectiveness, and provide regulators with greater
assurance of the company’s abilities
https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/applicationssubmissions/guidance-documents/international-conference-harmonisation/quality/adoption-internationalconference-harmonisation-technical-requirements-registration-pharmaceuticals-human-use.html
Principles of quality risk management
1. Evaluation of the risk to quality should be based on
scientific knowledge and ultimately link to the protection
of the patient
2. The level of effort, formality, documentation of the quality
risk management should commensurate with the level of
risk
https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/applicationssubmissions/guidance-documents/international-conference-harmonisation/quality/adoption-internationalconference-harmonisation-technical-requirements-registration-pharmaceuticals-human-use.html
Typical quality risk
management process
Look familiar?
https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/applicationssubmissions/guidance-documents/international-conference-harmonisation/quality/adoption-internationalconference-harmonisation-technical-requirements-registration-pharmaceuticals-human-use.html
Initiating quality risk management processes
• Define the problem
• Gather information data on the hazard, harm and impact
• Identify a leader and necessary resources
• Specify a timeline, deliverable and level of decision making
https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/applicationssubmissions/guidance-documents/international-conference-harmonisation/quality/adoption-internationalconference-harmonisation-technical-requirements-registration-pharmaceuticals-human-use.html
The risk assessment
• Involves identification of the hazards, analysis and evaluation
of risks
Remember, in the context of quality risk assessment in
pharmaceuticals the ’fundamental questions’ are:
1. What might go wrong?
2. What is the probability it will go wrong?
3. What are the consequences if it goes wrong?
https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/applicationssubmissions/guidance-documents/international-conference-harmonisation/quality/adoption-internationalconference-harmonisation-technical-requirements-registration-pharmaceuticals-human-use.html
Risk identification
We are identifying hazards related to the problem statement!
In Module 2, we discussed the identification process in more detail
including the use of tools such as a cause & effect diagram
Cause & effect diagrams
Mollah, A. H., Long, M., & Baseman, H. S. Risk management applications in pharmaceutical and
biopharmaceutical manufacturing. (2013)
Value chain analysis
Mollah, A. H., Long, M., & Baseman, H. S. Risk management applications in pharmaceutical and
biopharmaceutical manufacturing. (2013)
Can serve as an
effective tool to
identify risks along the
value chain
Preliminary
hazard
analysis
Mollah, A. H., Long, M., & Baseman, H. S. Risk management applications in pharmaceutical and
biopharmaceutical manufacturing. (2013)
Risk matrix
Probability of Harm
Severity of Harm
Risk analysis
• Remember, we talked about qualitative and quantitative
analysis in Module 2
• In quality risk management, detectability is a possible factor
in the estimation of risk i.e., our ability to detect the harm
Why do you think detectability may be important in quality
risk management?
https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/applicationssubmissions/guidance-documents/international-conference-harmonisation/quality/adoption-internationalconference-harmonisation-technical-requirements-registration-pharmaceuticals-human-use.html
Risk evaluation
• Refers to evaluating the the identified & analyzed risks
against a given risk criteria
• Considers the strength of evidence for the ‘fundamental
questions’
The outputs of risk assessment (identify, analyze, evaluate)
in quality risk management is a quantitative or qualitative
estimate or description of the risks respectively
https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/applicationssubmissions/guidance-documents/international-conference-harmonisation/quality/adoption-internationalconference-harmonisation-technical-requirements-registration-pharmaceuticals-human-use.html
Risk control
• To reduce a risk to an acceptable level
• Includes the decision to reduce and/or accept risks
Questions to ponder:
1. Is the risk above an acceptable level?
2. What can be done to reduce/eliminate the risks?
3. What is the balance between benefits, risks, resources?
4. Are new risks introduced as a result of the controls?
https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/applicationssubmissions/guidance-documents/international-conference-harmonisation/quality/adoption-internationalconference-harmonisation-technical-requirements-registration-pharmaceuticals-human-use.html
In quality risk management…
• Risk control is not just mitigation or elimination, but it can
also be to improve the detectability of hazards
• Acceptance of risks should be once the quality risk is reduced
to a specified acceptable level (as per risk management plan)
https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/applicationssubmissions/guidance-documents/international-conference-harmonisation/quality/adoption-internationalconference-harmonisation-technical-requirements-registration-pharmaceuticals-human-use.html
Risk communication
• Sharing of information about risk and risk management
between decision makers and other parties
• Communication can occur amongst parties at any point of
the risk management process
• All outputs of quality risk management processes should be
appropriately communicated and documented
• But not every risk and decision needs to be
communicated
https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/applicationssubmissions/guidance-documents/international-conference-harmonisation/quality/adoption-internationalconference-harmonisation-technical-requirements-registration-pharmaceuticals-human-use.html
Risk communication
can occur amongst
many parties
Can be about aspects of
risk such as: existence,
nature, form, probability,
severity, acceptability,
control, treatment,
detectability…
Regulators
Suppliers
https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/applicationssubmissions/guidance-documents/international-conference-harmonisation/quality/adoption-internationalconference-harmonisation-technical-requirements-registration-pharmaceuticals-human-use.html
Patients
Parties
Other
industry
Within the
company
Documentation is a form of communication &
may be alone sufficient for some risks
Mollah, A. H., Long, M., & Baseman, H. S. Risk management applications in pharmaceutical and
biopharmaceutical manufacturing. (2013)
Risk review
• Remember, risk management in general is an ongoing iterative
process
• Quality risk management is no different
• A mechanism to review & monitor events needs to be developed
https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/applicationssubmissions/guidance-documents/international-conference-harmonisation/quality/adoption-internationalconference-harmonisation-technical-requirements-registration-pharmaceuticals-human-use.html
Potential Applications for Quality
Risk Management
Part of integrated quality management
Documentation
Training
Defects
Auditing/Inspections
Periodic review
Change management/control
Continuous improvement
https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/applicationssubmissions/guidance-documents/international-conference-harmonisation/quality/adoption-internationalconference-harmonisation-technical-requirements-registration-pharmaceuticals-human-use.html
Part of regulatory operations
• Inspections & assessments
• How much resources are needed for inspections?
• How significant are the findings?
• What is the most appropriate post-inspection follow-up?
• Do we have the information to evaluate the submitted
information and impact of proposed changes?
• Are there risks that should be communicated between
inspectors?
https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/applicationssubmissions/guidance-documents/international-conference-harmonisation/quality/adoption-internationalconference-harmonisation-technical-requirements-registration-pharmaceuticals-human-use.html
Part of development
• Goal is to design a quality product and its manufacturing process to
consistently deliver the effectiveness of the product safely
https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/applicationssubmissions/guidance-documents/international-conference-harmonisation/quality/adoption-internationalconference-harmonisation-technical-requirements-registration-pharmaceuticals-human-use.html
Part of facilities, equipment & utilities
• Goal is to design, maintain, and keep facilities/equipment/utilities in a
state of quality
https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/applicationssubmissions/guidance-documents/international-conference-harmonisation/quality/adoption-internationalconference-harmonisation-technical-requirements-registration-pharmaceuticals-human-use.html
Part of materials management
• Goal is to ensure suppliers and contract manufacturers are up to the
quality standard in the appropriateness of the materials as well as the
associated supply chain
https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/applicationssubmissions/guidance-documents/international-conference-harmonisation/quality/adoption-internationalconference-harmonisation-technical-requirements-registration-pharmaceuticals-human-use.html
Part of production
• Goal is to ensure appropriate validation, in-process sampling/testing
and production planning
https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/applicationssubmissions/guidance-documents/international-conference-harmonisation/quality/adoption-internationalconference-harmonisation-technical-requirements-registration-pharmaceuticals-human-use.html
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First, you will need to complete an order form. It's not difficult but, if anything is unclear, you may always chat with us so that we can guide you through it. On the order form, you will need to include some basic information concerning your order: subject, topic, number of pages, etc. We also encourage our clients to upload any relevant information or sources that will help.
Complete the order form
Once we have all the information and instructions that we need, we select the most suitable writer for your assignment. While everything seems to be clear, the writer, who has complete knowledge of the subject, may need clarification from you. It is at that point that you would receive a call or email from us.
Writer’s assignment
As soon as the writer has finished, it will be delivered both to the website and to your email address so that you will not miss it. If your deadline is close at hand, we will place a call to you to make sure that you receive the paper on time.
Completing the order and download