Lee Crisanto G.

BSHM 1B

SYNTHESIS (RISK MANAGEMENT)

Approval of a product is a Critical Juncture, the Beginning of the lifecycle pursues and manages
emerging knowledge about risk–benefit uncertainty.

A risk management plan (RMP) details the safety profile of a medicine, the actions taken by the
marketing authorization holder to characterize the safety profile during post-marketing
pharmacovigilance activities, and the steps taken to prevent or reduce the risks associated with the
medicine in patients risk minimization measures. The objectives of the RMP are to Identify or
characterize the safety profile, How to characterize further, Measures to prevent or minimize risks
including assessment of the effectiveness of those measures, and document post-authorization
obligations

leads to Safety Specifications It’s really important to identify the risk for which there is
adequate evidence of an association, Important Potential Risks for which there is suspicion of an
association but no confirmation Important Missing Information about risk is not available and represents
a limitation of the safety data.

It’s really important to see the Impact on the risk-benefit balance of the product, the Impact on the
individual, and the seriousness of the risk and the Impact on public health, Risks to be included in the
‘contraindications’ or ‘warnings and precautions section of SmPC

leads to the Pharmacovigilance Plan. Routine pharmacovigilance (PSUR, ADR collection, and
analysis) or additional pharmacovigilance (PASS, measurement of effectiveness of Risk Minimization
Activity) should be provided for each of the safety conpediatricingle safety concern can have
nopediatricmultiple additional pharmacovigilanpediatricies. Protocols for the studies should be
submitted as part of the RMP with clear milestones.

leads to plans for post-authorization efficacy studies (PAES) For many medicines, PAES won't be
necessary. Long-term efficacy follow-up studies may be required for some medicinal products.
Marketing authorization applications that include a pediatric indication or will only seek a pediatric
indication. Applications to add a pediatric indication to existing marketing authorization. Advanced
therapy medicinal products.

the RMP handles Risk Minimisation Measures Routine Risk Minimisation (SmPC, Labelling,
Package leaflet, Pack size, Legal status of the product) Additional Risk Minimisation (DHPC, Educational
material, Controlled distribution system, Etc.) The Risk Minimisation Measures should be proportionate
to the risk The effectiveness of the Risk Minimisation Measures should be evaluated The Risk
Minimisation Measures should not be promotional in nature, and should not be a repetition of
information that is already clearly stated in the SmPC

Routine Risk Minimization (SmPC, Labeling, Package Leaflet, Pack Size, and Legal Status of the Product)
Additional Risk Minimization (DHPC, Educational Material, Controlled Distribution System, etc.) The Risk
Minimization Measures should be proportionate to the risk The effectiveness of the Risk Minimization
Measures should be evaluated The Risk Minimization Measures should not be promotional in nature,
and should not be a repetitious process

An RMP should be submitted at the initial marketing authorization application for new products. For
already existing marketing authorizations an RMP should be submitted at the time of a significant
change to the marketing authorization, or at the request of the Agency

The regulatory oversight of RMPs lies with the PRAC. The PRAC is involved in procedural and scientific
matters regarding RMPs as of its meeting in September 2012. The RMP will be assessed by the PRAC
Rapporteur. The PRAC provides ‘Advice’ to CHMP.

RMP is a living document that will be updated throughout the life cycle of the product Each update will
be assessed by the PRAC An updated RMP should be submitted

At the request of the European Medicines Agency, Whenever the risk management system is modified,
especially as the result of new information being received that may lead to a significant change to the
benefit/risk profile or as the result of an important (pharmacovigilance or risk minimization) milestone
being reached.

The revised RMP should be provided in CTD section 1.8.2, using the document structure as provided in
the guidance. For updates of existing RMPs: Until further notice companies have to send in all parts of
the RMP so that a complete RMP is provided to the Agency.

The outlines of the educational program (i.e. the key elements) are part of Annex II of the marketing
authorization. Assessment of the educational program incorporating these key elements is

done at the Member State level since the GVP Module V chapter V.C.7 states that Member States have
the responsibility for ensuring that the key elements described in the conditions and/or restrictions are
implemented by the marketing authorization holder in their territory.

An RMP summary is required for all medicines authorized. The current approach is that subsequent
updates could be used to ensure all medicines have an RMP summary. The summary of the RMP for
each medicinal product shall be made publically available.

The company of the generic medicinal product should use the (E)PAR and the SPC of the reference
medicinal product to obtain the safety concerns to be included in module SVIII of the RMP. Companies
may also discuss with the relevant competent authority what safety concerns should be included.

In summary Proactive approach, characterizes the safety profile, and Prevents or minimizes the risks.
PRAC oversight Living document.

Many conventional fields, including business, industry, healthcare, conflict resolution, sociology, and the
like, have used risk management techniques. Risk-taking is said to be encouraged by it. One may take on
complicated, difficult undertakings or venture into new, uncharted territory with more confidence and
courage by recognizing and managing the risks. However, the software industry has recently started to
acknowledge it as a recommended practice. There are several explanations. Increasing business
volatility, rapidly evolving technology, higher customer satisfaction, globalization, a significant influence
on business disruption, and similar factors are some of them. Over the last few decades, a lot of studies
have been done in the area of software risk management. There are now several frameworks and
models that offer different risk kinds, risk management techniques, process models, and performance
metrics as a result of this. The condition of risk management practice is not well understood in spite of
this. There aren't any papers that describe the general state of risk management and how it works with
the development process, as far as the authors of this study are aware. Because of this, we venture to
assert that the software community now lacks knowledge of the state of risk management practice in
the workplace. In this study, we examine the current state of risk management and how 37 software
businesses have integrated it with software development. Our objectives are to ascertain the current
state of the risk management process in the industry; compare standard process models to actual
industrial practice; ascertain how the industry has integrated risk management with its development
processes; ascertain problems that may help to enhance the integrated process; and ascertain the
distinctions between agile and other development methodologies.

Identifying any incident that might potentially have a negative (risk) or good (opportunity) impact on the
project's goals is the first stage in the risk management process.

Project milestones, Financial trajectory of the project, and Project scope

These occurrences can be recorded in the risk register and then reported in the risk matrix.

A risk's (or opportunity's) description, causes, and effects, as well as its qualitative and quantitative
evaluations and mitigation strategy, all serve to define it. It may also be described by the person who is
in charge of the action. A risk (or opportunity) must have each of these qualities in order to be real.

The risks and opportunities (R&O) identified must be as accurate and detailed as possible in order to be
managed properly. The risk or opportunity's title needs to be brief, self-explanatory, and clearly stated.

R&O may and should be identified by all project participants, and the Risk (or Opportunity) Owners are
in charge of determining its substance. The official process for identifying risks and creating response
plans must be carried out through discussions with risk owners, and that is the responsibility of risk
managers. In our upcoming post on the duties of the risk management team, we will go into further
depth about each of these jobs.

Using the methods of established methodologies, such as Failure Modes, Effects and Criticality Analysis
(FMECA), cause trees, etc., while analyzing the documentation already in existence, conducting expert
interviews, holding brainstorming sessions, taking into account the lessons learned from R&Os
encountered in previous projects, and using pre-established checklists or questionnaires covering the
various project areas (Risk Breakdown Structure or RBS).
Risk and opportunity evaluations come in two flavors: qualitative and quantitative. A qualitative analysis
examines the degree of criticality in light of the likelihood and consequences of the event. A quantitative
analysis examines the event's financial impact or benefit. Both are required for a thorough assessment
of risks and opportunities.

QUALITATIVE ASSESSMENT

According to the criticality scales for the project, the risk owner and risk manager will rank and order
each identified risk and opportunity by effect severity and occurrence likelihood.

Assessing the impact's seriousness

Estimating the seriousness of each of the consequences identified at the project level is important in
order to evaluate the total impact. The various impacts and their severity are rated on a scale. This
guarantees a consistent and trustworthy evaluation of the risk and opportunity.

QUANTITATIVE ASSESSMENT

In the majority of projects, the goal of the quantitative assessment is to create a financial appraisal of
the potential financial benefit or effect of risk or opportunity. Depending on the organizational structure
of the firm, either the risk owner, the risk manager (with assistance from those in charge of estimates
and numbers), or the management controller is responsible for carrying out this stage. These sums
reflect an unanticipated prospective expense that was not included in the project budget, or a possible
profit if we are talking about an opportunity.

An organization must first prepare a treatment plan that details its strategy for managing hazards. The
goal of the risk treatment strategy is to lessen the likelihood that the risk will materialize (preventive
action) and/or to lessen the effect of the risk (mitigation action). The goal of a treatment plan for an
opportunity is to boost the chance that it will materialize and/or to boost its advantages. A response
plan is established for the project based on the type of risk or opportunity.

It is necessary to monitor and report on risks, opportunities, and the strategy for addressing them. The
importance of the danger or opportunity will determine how often this occurs. It will be made sure
there are suitable venues for escalation and that the right risk responses are being taken by creating a
monitoring and reporting framework.
Risk Management Process Review

The goal of risk management is to recognize possible issues before they arise so that risk-handling
actions may be planned and implemented as necessary during the course of a project or product to
reduce negative effects on accomplishing goals.

A crucial component of technical and corporate management procedures, risk management is an

ongoing, forward-looking activity. Risk management should address problems that can jeopardize the
accomplishment of crucial goals. To successfully predict and minimize the risks that have a significant
influence on the project, a continuous risk management method is used.

Early and proactive risk identification is a key component of effective risk management, which is
accomplished with the cooperation and participation of pertinent stakeholders. To create a climate for
unrestricted disclosure and discussion of risk, strong leadership from all key stakeholders is required.

Although early on and during all project phases, technical difficulties are the top concern, risk
management must take both internal and external sources for cost, schedule, and technical risk into
account. Because it is often simpler, less expensive, and less disruptive to make modifications and rectify
work efforts during the earlier, rather than the later phases of the project, early and aggressive risk
detection is crucial.

The three components of risk management include developing a risk management strategy, recognizing
and assessing risks, and addressing discovered risks, which may include putting risk mitigation measures
into action as necessary.

Recommendation

The process of discovering, evaluating, and controlling risks to an organization's resources and profits is
known as risk management. A competent risk management program aids a company in taking into
account the complete spectrum of risks it encounters, including financial uncertainties, legal obligations,
technological problems, strategic management blunders, accidents, and natural catastrophes. The link
between risks and the potential negative cascade effects on the strategic objectives of an organization is
also examined by risk management.