Course Code: PHA 056

Student Activity Sheet #9

Name: _________________________________________________________________ Class number: _______

Section: ____________ Schedule: ________________________________________ Date: ________________

Lesson title: Clinical Trials; Pharmacovigilance, Post marketing Materials:

surveillance and Intellectual property protection. {Pen, highlighters, & students activity
Lesson Objectives: sheet}
At the end of the lesson, you should be able to:
1. Differentiate Pharmacovigilance from Post marketing surveillance. References:
2. Discuss the types of intellectual properties & its importance. 1. Rosa, C., Campbell, A. N.,
Miele, G. M., Brunner, M., &
Winstanley, E. L. (2015). Using e-
technologies in clinical trials.
Contemporary clinical trials, 45(Pt
A), 41–54.
https://doi.org/10.1016/j.cct.2015.
07.007
2.
https://www.pv-education.org/me
dia/1085/text_lecture01_general-i
ntroduction-pv_lareb_who_2017.
pdf

Productivity Tip: Luke 18:27 But He said, “The things that are impossible with people are possible with
God.” How you see yourself reflects your performance. Always make it a habit to remind your heart & mind
as to why are you doing this? To whom do you dedicate these efforts? You are capable of doing great
things and it starts with discipline. Set a time to focus only on your studies, set a time for rest. And learn to
organize the things that you do. Use a journal to write your progress, list down your pros and cons and
you`ll be able to find solution and progress not only in your studies but in your journey.

A. LESSON PREVIEW/REVIEW
Introduction ( 3 mins)

Uncertainty about the safety of commonly used medicines, gives rise to concerns in the public. Future health
care professionals need to realize that adverse outcomes of drug use occur and are mostly unpredictable.
They need to learn what to tell patients about the knowledge on safety of drugs and how to act in situations
when adverse drug reactions.

Activity 1: What I Know Chart, part 1 (5 mins) Answer only the first column, “What I know”. Leave the third
column “What I Learned” blank at this time.

What I Know Questions: What I Learned (Activity 4)

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1. What is the meaning of

ecological momentary
assessment?

2. What is adverse drug

reaction?

3. What is the issue given by the

drug thalidomide?

B.MAIN LESSON

POST- MARKETING SURVEILLANCE

PHASES OF CLINICAL TRIALS

Phase I: First in man Safety

Phase II: First in Patient –dose, dosage forms
Phase III: Efficacy, ADRs
Post-marketing Surveillance or Phase IV: Evaluation of the real clinical setting.

= Postmarketing surveillance (PMS), in simple terms, refers to the process of monitoring the safety of drugs
once they reach the market after the successful completion of clinical trials. The primary purpose for the
conduct of PMS is to identify previously unrecognized adverse effects as well as positive effects. Other
essential components can include off- label drug use, issues with orphan drugs and problems associated with
the conduct of international clinical trials in the paediatric population.
-
- PMS is an essential tool that helps to correlate the strength of the exposed drug with that of the
adverse events, thereby painting a clearer picture with regard to the types of positive or negative effects that
a drug may threaten to pose, over a prolonged period of administration.
No fixed duration/Patient population -

Starts immediately after marketing ~

Report all ADRs -
Help to detect -
Rare ADRs -
Drug interaction -
Also new uses for drugs[sometimes called Phase V] ~

Benefits of Postmarketing Monitoring

The ability to study the following:
• Low frequency reactions (not identified in clinical trials)
• High risk groups
• Long-term effects
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• Drug-drug/food interactions
• Increased severity and / or reporting frequency of known reactions

METHODS OF SURVEILLANCE
Thus, four types of studies are generally used to identify drugs effects:
1. Controlled clinical trials:
To minimize bias through such method as randomization and “double-blinding’’.
Directly monitor patients for the duration of studies.
For evaluating a drug’s efficacy and safety.
They are often costly.
2.Spontaneous or voluntary
reporting
By physician and other health provider & hospital may alert FDA and pharmaceutical firms to possible
adverse effects of drugs.
3. Cohort studies :
Studies follow a defined group of patient for a period of time.
Patient are not randomly assigned , & there is no blinding.
If adverse reaction occur. A second group of patient with the same medical condition , who are not
taking the drug and who may be receiving alternative treatment.
4. Case-control studies :
Case control studies identify patient with the adverse effects to be studied, and compare them with the
sample drawn from the same cohort that gave rise to cases.
PMS PROCEDURE
It should assign departments or position a responsible for performing a particular function.
Manufacturer may find it helpful to a have report at the end of year, as well as PMS tracking
schedule and log. This information could constitute feedback received from user .
Information obtained from PMS system should be communicated , at a minimum, annually during a
management review meeting-which is top managements examination of the organizations quality
management system.

Postmarket Adverse Event Reporting and MedWatch

Postmarketing safety reporting requirements
• Under 21 CFR 314.80 postmarketing safety reports must be submitted to the agency for the following:
15- day Alert reports: Serious and unexpected adverse experience from all sources
(domestic and foreign) Periodic Adverse Events Reports: Domestic spontaneous adverse
events that are:
- Serious and expected
- Non-serious and unexpected
- Non-serious and expected
- Quarterly for the first 3 years then annually

Spontaneous Reports
• A communication from an individual (e.g., health care professional, consumer) to a company or regulatory
authority
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• Describes a suspected adverse event(s)

• Passive and voluntary reports

What is a Safety Signal?

• Reported information on a possible causal relationship between an adverse event and a drug
• The relationship being previously unknown or incompletely documented
• Usually supported by multiple case reports
• New unlabeled adverse events
• An observed increase in a labeled event OR a greater severity or specificity
• New interactions
• Newly identified at-risk Population

Components of a Good Postmarketing Report

• Description of adverse event
• Suspected and concomitant product therapy details (e.g., dose, dates of therapy)
• Patient characteristics (e.g., age, sex), baseline medical condition, comorbid condition, family history, other
risk factors
• Documentation of the diagnosis
• Clinical course and outcomes
• Relevant therapeutic measures and laboratory data
• Dechallenge and rechallenge information
• Reporter contact information
• Any other relevant information

Safety Evaluators (SEs)

10 teams of SEs
– Majority clinical pharmacists
– Provide critical analysis of sources of post marketing data to identify and evaluate safety signals

Medical Officers (MOs)

• Provide clinical expertise in various therapeutic areas such as dermatology, oncology, rheumatology, etc.
• Collaborate with Division of Pharmacovigilance’s (DPV) teams on safety evaluation
• Collaborate with Office of New Drugs (OND) on safety evaluation

PHARMACOVIGILANCE
-
Public concerns

● Uncertainty about the safety of commonly used medicines, gives rise to concerns in the public. Future
health care professionals need to realize that adverse outcomes of drug use occur and are mostly

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 Course Code: PHA 056
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Name: _________________________________________________________________ Class number: _______

Section: ____________ Schedule: ________________________________________ Date: ________________

unpredictable. They need to learn what to tell patients about the knowledge on safety of drugs and how
to act in situations when adverse drug reactions occur.

Pharmacovigilance Definition

-● The WHO defines pharmacovigilance as the science and activities relating to the detection,
assessment, understanding and prevention of adverse drug effects or any other drug related problem.
● The major concern for pharmacovigilance is the post-marketing surveillance phase of a drug. Although
a drug is extensively studied in clinical trials, knowledge on adverse outcomes of drug use in practice is
lacking. Experiences of adverse outcomes of drug use in practice help to detect, assess and
understand adverse drug effects.
● This knowledge derived from practice can help to prevent adverse drug effects in future patients. This
process is also called signal detection.

Divisions of Pharmacovigilance
• Evaluate the safety of drug and therapeutic biologic products
• Advance public health by detecting and analyzing safety signals from all available data sources,
utilizing evidence based methods
• Recommend appropriate regulatory actions, including labeling changes, Risk Evaluation and
Mitigation Strategies (REMS), etc.
• Communicate relevant safety information

ADR Definition

-● An adverse drug reaction is a response to a drug which is noxious and unintended, and which occurs at
doses normally used in man for prophylaxis, diagnosis, therapy or for the modifications of physiological
function.
● Although most ADRs are noxious, sometimes an unexpected beneficial effect is detected.
● For example: abnormal growth (hypertrichosis) of eye lashes, induced by prostamides (or synthetic
prostaglandin F2α –analogues) like bimatoprost. This class of drugs is used for increased intraocular
pressure or glaucoma.

● For cosmetic purposes, the adverse drug effect of hypertrichosis has been turned into a new indication:
eye lash hypotrichosis. A better known adverse drug effect that turnedinto a new indication is the
platelet aggregation inhibition of Aspirin® (acetylsalicylic acid), used as ananalgesic causing increased
bleeding tendency.
● Note the terminology: an ADR is a response (or reaction) of a drug in a person, implying a causal
relationship between drug action and a person’s physiological reaction that is experienced as harm.
● Some articles or sources of information mention ‘ADE’ (adverse drug event) which is an event that is
temporarily associated with the use of a drug, but which is not necessarily causally related. [For
example: dry cough in someone since he started an antibiotic for a respiratory infection.]

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● The same accounts for ‘AE’ (adverse event) for which a causal relationship between the event and drug
has not been established, and which might rely on coincidence. [For example: in a trial 5% of the
treatment group experienced nausea to 4% of the control group.] It is rather confusing that a ‘side
effect’ can account for ADR, ADE and AE, depending on the context. In fact, only an ADR is a true side
effect of a drug.

Seriousness

● Seriousness of an ADR is related to its life threatening nature and is defined as any untoward reaction
to the medicinal product that 1) results in death, 2) is life-threatening, 3) requires hospitalization or
prolongation thereof, 4) causes permanent incapacity or disability, 5) causes birth defects or 6) causes
other medically important conditions.
● This is not the same as perceived severity of ADRs by patients, which has impact on their health
condition, quality of life and might influence drug use.

Drug safety in practice:

Hospitalizations

● Adverse drug reactions can cause serious health problems. Studies indicate that ADRs account for
approximately 5-6% of all acute hospitalizations. About half of these hospitalizations could have been
prevented by better monitoring, timely recognition of the symptoms and by knowledge about certain risk
factors for occurrence of ADRs. Therefore healthcare professional (HCP) knowledge about the safe use
of drugs in daily practice is important to reduce drug-induced patient harm.

Need for monitoring safety of drugs

History

● Because of the thalidomide disaster, causing limb deformities in babies whose mothers took
thalidomide during pregnancy, people started to realize that the safety of drugs should be monitored
closely.
● Phocomelia is a very rare congenital anomaly, which was already known in the 18th century. In the
1950’s more children were born with deformed or absent limbs, caused by teratogenic effects of
thalidomide (Softenon®, Distaval®). This drug was used against morning sickness or as sedative. In
1961 thalidomide was withdrawn from the market.
● Thalidomide is a racemic mixture of molecules, of which S-thalidomide is the bioactive form. Although
the exact mechanism in not clear, thalidomide is thought to inhibit angiogenesis (forming of blood
vessels) and to generate reactive oxygen species that damage and kill cells. These actions gave a new
therapeutic use for thalidomide is multiple myeloma (cancer), leprosy and some other off-label uses.
● Another drug-induced disaster was the use of di-ethylstilbestrol (DES) in pregnant women to prevent
miscarriages, causing serious health problems in the offspring. Daughters from mothers that used DES,
have an increased risk on cervical cancers and deviations in the shape of the uterus. This drug had

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Name: _________________________________________________________________ Class number: _______

Section: ____________ Schedule: ________________________________________ Date: ________________

been used from 1946-1974. Since the effects on offspring of the users of this drug, people still suffer
from these adverse (teratogenic) drug reaction.

Organization of pharmacovigilance

● Although drugs have been extensively studies in pre-marketing trials, post-marketing safety has to be
assured. In the post-marketing phase, new information on safety is derived from spontaneous reporting
systems (SRS) or from additional studies. This new knowledge is constantly used for monitoring the
balance between efficacy and safety of a drug.

● Marketing authorization holders (MAH) keep responsible for their marketed drugs and have to update
the safety of their products periodically in Periodic Safety Update Reports (PSUR). For newly marketed
drugs, MAHs write Risk Management Plans (RMP) to point out which risks can be expected and to
manage them.

International

● The UMC-WHO database of ADRs, also called VigiAcces®, collects all reported ADRs from countries
that are members of WHO. This worldwide database is used for signal detection of new knowledge on
ADRs.

Intellectual property (IP) pertains to any original creation of the human intellect such as artistic, literary,
technical, or scientific creation. Intellectual property is divided into two categories:
Industrial Property includes patents for inventions, trademarks, industrial designs and geographical
indications.
Copyright covers literary works (such as novels, poems and plays), films, music, artistic works (e.g., drawings,
paintings, photographs and sculptures) and architectural design. Rights related to copyright include those of
performing artists in their performances, producers of phonograms in their recordings, and broadcasters in
their radio and television programs.

- Intellectual property rights (IPR) refers to the legal rights given to the inventor or creator to protect his
invention or creation for a certain period of time. These legal rights confer an exclusive right to the
inventor/creator or his assignee to fully utilize his invention/creation for a given period of time. These rights are
outlined in Article 27 of the Universal Declaration of Human Rights, which provides for the right to benefit from
the protection of moral and material interests resulting from authorship of scientific, literary or artistic
-
productions. PR is a strong tool, to protect investments, time, money, effort invested by the inventor/creator of
an IP, since it grants the inventor/creator an exclusive right for a certain period of time for use of his
invention/creation. Thus IPR, in this way aids the economic development of a country by promoting healthy
competition and encouraging industrial development and economic growth.

The importance of intellectual property was first recognized in the Paris Convention for the Protection of
Industrial Property (1883) and the Berne Convention for the Protection of Literary and Artistic Works (1886).
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Name: _________________________________________________________________ Class number: _______

Section: ____________ Schedule: ________________________________________ Date: ________________

Both treaties are administered by the World Intellectual Property Organization (WIPO).

Why promote and protect intellectual property?

✔ The progress and well-being of humanity rest on its capacity to create and invent new works in the areas
of technology and culture.
✔ The legal protection of new creations encourages the commitment of additional resources for further
innovation.
✔ The promotion and protection of intellectual property spurs economic growth, creates new jobs and
industries, and enhances the quality and enjoyment of life.

Types of Intellectual Properties

- A patent is an exclusive right granted for an invention – a product or process that provides a new way
of doing something, or that offers a new technical solution to a problem. A patent provides patent owners with
protection for their inventions. Protection is granted for a limited period, generally 20 years.

What kind of protection do patents offer?

Patent protection means an invention cannot be commercially made, used, distributed or sold without the
patent owner’s consent. Patent rights are usually enforced in courts that, in most systems, hold the authority
to stop patent infringement. Conversely, a court can also declare a patent invalid upon a successful
challenge by a third party.

What rights do patent owners have?

A patent owner has the right to decide who may – or may not – use the patented invention for the period
during which it is protected. Patent owners may give permission to, or license, other parties to use their
inventions on mutually agreed terms. Owners may also sell their invention rights to someone else, who then
becomes the new owner of the patent. Once a patent expires, protection ends and the invention enters the
public domain. This is also known as becoming off patent, meaning the owner no longer holds exclusive
rights to the invention, and it becomes available for commercial exploitation by others.

How is a patent granted?

1. File a patent application.

a) Title of the invention, as well as an indication of its technical field.
b) Background and a description of the invention, in clear language and enough detail that an
individual with an average understanding of the field could use or reproduce the invention. Such
descriptions are usually accompanied by visual materials – drawings, plans or diagrams – that
describe the invention in greater detail.
c) The application also contains various “claims”, that is, information to help determine the extent of
protection to be granted by the patent.

- A trademark is a distinctive sign that identifies certain goods or services produced or provided by an
individual or a company. Its origin dates back to ancient times when craftsmen reproduced their signatures,
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Section: ____________ Schedule: ________________________________________ Date: ________________

or “marks”, on their artistic works or products of a functional or practical nature. Over the years, these marks
have evolved into today’s system of trademark registration and protection. The system helps consumers to
identify and purchase a product or service based on whether its specific characteristics and quality – as
indicated by its unique trademark – meet their needs.
>
Trademark protection ensures that the owners of marks have the exclusive right to use them to identify
goods or services, or to authorize others to use them in return for payment. The period of protection varies,
but a trademark can be renewed indefinitely upon payment of the corresponding fees. Trademark protection
is legally enforced by courts that, in most systems, have the authority to stop trademark infringement.

How is a trademark registered?

✔ First, an application for registration of a trademark must be filed with the appropriate national or regional
trademark office. The application must contain a clear reproduction of the sign filed for registration,
including any colors, forms or three-dimensional features. It must also contain a list of the goods or
services to which the sign would apply. The sign must fulfill certain conditions in order to be protected as
a trademark or other type of mark. It must be distinctive, so that consumers can distinguish it from
trademarks identifying other products, as well as identify a particular product with it. It must neither
mislead nor deceive customers nor violate public order or morality. Finally, the rights applied for cannot
be the same as, or similar to, rights already granted to another trademark owner. This may be
determined through search and examination by national offices, or by the opposition of third parties who
claim to have similar or identical rights.

-Copyright laws grant authors, artists and other creators’ protection for their literary and artistic creations,
generally referred to as “works”. A closely associated field is “related rights” or rights related to copyright that
encompass rights similar or identical to those of copyright, although sometimes more limited and of shorter
duration.
The creators of works protected by copyright, and their heirs and successors (generally referred to as “right
holders”), have certain basic rights under copyright law. They hold the exclusive right to use or authorize
others to use the work on agreed terms. The right holder(s) of a work can authorize or prohibit: its
reproduction in all forms, including print form and sound recording; its public performance and
communication to the public; its broadcasting; its translation into other languages; and its adaptation, such
as from a novel to a screenplay for a film.
Industrial designs relates to features of any shape, configuration, surface pattern, composition of lines and
colors applied to an article whether 2-D, e.g., textile, or 3-D, e.g., toothbrush

Geographical indications are indications, which identify as good as originating in the territory of a
country or a region or locality in that territory where a given quality, reputation, or other characteristic of the
goods is essentially attributable to its geographical origin
Infringement
a breach or infraction, as of a law, right, or obligation; violation; transgression to the violation of a law or

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a right. Infringement may refer to:

● Infringement procedure, a European Court of Justice procedure to determine whether a Member State
has fulfilled its obligations under Union law
● Intellectual property infringement, violating an owner's exclusive rights to intangible assets such as
musical, literary, or artistic works
o Copyright infringement, the use of works under copyright, including reproducing, distributing,
displaying, or performing the copyrighted work without permission
o Patent infringement, using or selling a patented invention without permission from the patent
holder, typically for commercial purposes
o Trademark infringement, a violation of the exclusive rights attaching to a trademark without the
authorization of the trademark owner or licenses
● Secondary infringement, when a party contributes to or is responsible for infringing acts carried out by
another party
● Summary offence or infraction, a crime that can be proceeded against without a jury trial and/or indictment
in some jurisdictions

Sec. 21. Patentable Inventions. - Any technical solution of a problem in any field of human activity
which is new, involves an inventive step and is industrially applicable shall be patentable. It may be, or may
relate to, a product, or process, or an improvement of any of the foregoing. (Sec. 7, R. A. No. 165a)
Sec. 22. Non-Patentable Inventions. - The following shall be excluded from patent protection:
22.1.Discoveries, scientific theories and mathematical methods;
22.2.Schemes, rules and methods of performing mental acts, playing games or doing business, and
programs for computers;
22.3 Methods for treatment of the human or animal body by surgery or therapy and diagnostic methods
practiced on the human or animal body. This provision shall not apply to products and composition for use in
any of these methods;
22.4.Plant varieties or animal breeds or essentially biological process for the production of plants or animals. This
provision shall not apply to micro-organisms and non-biological and microbiological processes.
Provisions under this subsection shall not preclude Congress to consider the enactment of a law
providing sui generis protection of plant varieties and animal breeds and a system of community intellectual
rights protection
22.5.Aesthetic creations
22.6.Anything which is contrary to public order or morality. (Sec. 8, R. A. No. 165a)

Activity 3: Skill-building Activities (with answer key) (20 mins + 3mins checking) (20 points)

A. True or False.
INSTRUCTION: Write true if it`s true, write false if it`s false.
IPR
-F
________1. Industrial Property refers to the legal rights given to the inventor or creator to protect his invention
or creation for a certain period of time.

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Name: _________________________________________________________________ Class number: _______

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I
________2. A patent owner has the right to decide who may – or may not – use the patented invention for the
period during which it is protected.
F
________3. Patent protection means an invention can be commercially made, used, distributed or sold if
provided with the patent owner’s consent. cannot
I
________4. Trademarks origin dates back to ancient times hen craftsmen reproduced their signatures, or
“marks”, on their artistic works or products of a functional or practical nature.
F
________5. Sec 22 Non patentable Inventions talk about - Any technical solution of a problem in any field of
21
human activity which is new, involves an inventive step and is industrially applicable shall be patentable.

I
________6.Phase IV of clinical trials can be only possible through pharmacovigilance.
________7.Daughters from mothers that used DES, have an increased risk on cervical cancers and deviations
in the shape of the uterus.
authorization
F
________8.Marketing association holders (MAH) keep responsible for their marketed drugs and have to
update the safety of their products periodically in Periodic Safety Update Reports (PSUR).

I
________9.Thalidomide can be also used for cancer.
ADR
________10.An adverse drug event is a response to a drug which is noxious and unintended, and which
occurs at doses normally used in man for prophylaxis, diagnosis, therapy or for the modifications of
physiological function.

Activity 4: What I Know Chart, Part 2 (4 mins) Instruction: To review what was learned from this session,
please go back to Activity 1 and answer the “What I Learned” column. Notice and reflect on any changes in
your answers.

Activity 5: CHECK FOR UNDERSTANDING (15 mins)

Instruction: Write the answer on the space provided.

A. Multiple Choice
1.Any technical solution of a problem in any field of human activity which is new, involves an inventive step and
is industrially applicable shall be patentable. Section 21 Patentable inventions
⑧ a. Statement is true
A b. Statement is false
2. A strong tool, to protect investments, time, money, effort invested by the inventor/creator of an IP.
a. Copyright
B ⑧b. IPR
c. Patent
3. Which of the following is/are true about patent?
0 a. exclusive right granted for an invention -
/W b. granted for 15 years 20 years

E- O c. A patent provides patent owners with protection for their inventions. -

d. A and B
e. A and C
4. Distinctive sign that identifies certain goods or services produced or provided by an individual or a
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B company.
a. Patent
Ob. Trademark
c. Copyright
5. What rights do patent owners have?
a. To decide who may – or may not – use the patented invention -

b. Right to collect fees X

A c. Right to report other inventions X
d. AOTA

B. Enumeration
of nowh
1-3.) Provide 3 benefits of Post Marketing Monitoring tood;
renwag" treat
Low frequency reactions
high risks groups long thects
________________,________________,________________,
-

distrion reactions

4-5.) Under Methods of surveillance there are four types of studies that are generally used to identify drugs
effects. Provide at least 2.
Controlled clinical
tridls volspontaneoing; cohortstudies;case-control
________________,________________, studies

C. LESSON WRAP-UP

Activity 6: Thinking about Learning (5 mins)

A. Work Tracker. You are done with this session! Let’s track your progress. Shade the session
number you just completed.
P1 P2
1 2 3 4 5 6 7 8 9 10

B. Think about your Learning. Tell me about your thoughts! Today we talked about The Current Systems and
Technology in Clinical Trials & Pharmacovigilance. What are your thoughts about the lesson today? How
important is this topic to our practice?

_____________________________________________________________
_____________________________________________________________
_____________________________________________________________
_____________________________________________________________
_____________________________________________________________
________________________________________________________.

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FAQs
1.) What is thalidomide used for before?
In the 1950s and 1960s, thalidomide was used to treat morning sickness during pregnancy.
© 1998-2022 Mayo Foundation for Medical Education and Research (MFMER). All rights reserved.

2.) When did pharmacovigilance started? The history of Pharmacovigilance started 169 years ago, on Jan
29, 1848, when a young girl (Hannah Greener) from the north of England died after receiving chloroform
anaesthetic before removal of an infected toenail.
National Library of Medicine 8600 Rockville Pike Bethesda, MD 20894

KEY TO CORRECTIONS

Activity #3

A.
1. False
2. True
3. True
4. True
5. False
6.True
7.True
8.False
9.True
10.False

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