SAS - CDISC CO DOMAIN×

Graphics with Pyton ×

SAS - CDISC Terminologies ×

STATISTICS R ×

SIGNAL DETECTION & AI ×

SAS MACROS ×

Test your knowledge in the new Pharmacovigilance Regulation in Animal Health! ×

Scope of the new regulation - Question 1/10

What does the Regulation of the European Parliament on veterinary medicinal products apply to?

	Veterinary medicinal products prepared industrially and intended to be placed on the market
	Veterinary medicinal products intended for research and development
	Veterinary medicinal products prepared in a pharmacy in accordance with a veterinary prescription
	Products containing autologous or allogeneic cells or tissues that have not been subjected to an industrial process

Check all responses that apply

07-DEC-2021

Veterinary medicinal product - Question 2/10

Among the following conditions, which make a substance a veterinary medicinal product?

	The substance contains microorganisms exerting a beneficial effect on the animal which ingest them
	The substance is presented as having properties for treating a preventing disease in animals
	The purpose of the substance is to be used for euthanasia of animals
	The purpose of the substance is to be used in animals with a view to making a medical diagnosis
	The substance is a preparation obtained from plants

Check all responses that apply

07-DEC-2021

Immediate packaging - Question 3/10

What information must be included on the immediate packaging of veterinary medicinal products?

	The name of the product
	A warning that the product is “for animal treatment only”
	The target species
	A warning that the product must be kept out of the sight and reach of children
	The expiry date

Check all responses that apply

07-DEC-2021

Outer packaging - Question 4/10

What information must be included on the outer packaging of veterinary medicinal products?

	Information concerning the distribution of the product
	A warning that the product is “for animal treatment only”
	The contra-indication and the adverse event
	The marketing authorization number
	The batch number preceded by the word “Lot”

Check all responses that apply

07-DEC-2021

Leaflet - Question 5/10

What information must be included on the leaflet of veterinary medicinal products?

	Information concerning the distribution of the product
	The indication for use
	The contra-indication and the adverse event
	The marketing authorization number
	The batch number preceded by the word “Lot”

Check all responses that apply

07-DEC-2021

Veterinary prescription - Question 6/10

In which situations a veterinary medicinal product is not subject a veterinary prescription?

	The administration of the product is restricted to pharmaceutical forms requiring no particular knowledge or skill in using the products
	The product does not present a direct or indirect risk, even if administered incorrectly, to the animal
	The product is an antimicrobial veterinary medicinal product
	The summary of the product characteristics does not contain any warnings of potential serious adverse events deriving from its correct use
	The product is a veterinary medicinal products used for euthanasia of animals

Check all responses that apply

07-DEC-2021

Pharmacovigilance tasks - Question 7/10

What are tasks of Pharmacovigilance for veterinary medicinal products?

	Redaction of Regulations on veterinary medicinal products
	Detection of adverse reactions in animals
	Detection of adverse reactions in humans after use of veterinary medicinal products in animals
	Protection of public health, animal health and the environment
	Decision to market or not a veterinary medicinal products

Check all responses that apply

07-DEC-2021

MedDRA coding - Question 8/10

Which terms can be HLT term when the SOC term is “Blood and lymphatic system disorders”?

	Blood and lymphatic system disorders (NOS)
	Coagulation abnormalities
	Thrombosis
	Red blood cell investigations

Check all responses that apply

07-DEC-2021

ABON Classification - Question 9/10

What are the minimum criteria for inclusion of an adverse event in the category A (probable) using the ABON system?

	There should be a reasonable association in time between the administration of the veterinary medicine and onset and duration of the reported adverse event
	It necessary results in death
	The description of the clinical phenomena should be consistent with given the known pharmacology and toxicology of the product
	It results in persistence on significant disability
	There should be no other equally plausible explanations of the case

Check all responses that apply

07-DEC-2021

Signal Detection - Question 10/10

In the EMA database, what conditions must be met for AEs to be marked as a possible signal?

	[PRR-] > 1 (lower limit of the 95% confidence interval)
	[PRR+] > 5 (higher limit of the 95% confidence interval)
	Number of cases > 3
	At least one Fatal case

Check all responses that apply

07-DEC-2021

If you usually work in the human health field, we hope that you enjoyed your short trip to animal health!

07-DEC-2021

AI (NATURAL LANGUAGE PROCESSING) & PV ×

Regulatory Inspections ×

Click here to download the list of reference web sites and frequent inspection findings we presented in this video

MACHINE LEARNING ×

COVID19 & NEW TECHNOLOGIES ×

STATISTICS R ×

PV AGGREGATE REPORTS ×

SAS PROC SQL ×

Test your knowledge in GDPR! ×

Objectives - Question 1/10

What are the objectives of GDPR?

	To protect personal data of UE citizens
	To provide transparency by sharing all processed data with European institutions
	Store the personal data of European internet users
	Provide a legal framework for the processing of personal data
	Empowering companies in the fight for data protection

Check all responses that apply

15-DEC-2021

Penalties - Question 2/10

What can be the penalties for non-compliance with GDPR?

	10 million euros fine
	20 million euros fine
	25 million euros fine
	4% of annual turnover
	8% of annual turnover
	10% of annual turnover

Check all responses that apply

15-DEC-2021

Conditions - Question 3/10

What conditions make the data processing lawful?

	Data subject has given his consent to the processing of personal data
	Data subject has been clearly informed that the data is being processed
	Processing is necessary to protect the vital interests of the data subject
	Processing is necessary for compliance with a legal obligation to which the controller is subject
	The processing and storage of data is temporary

Check all responses that apply

15-DEC-2021

Countries - Question 4/10

In which countries can the data of European residents be transferred freely?

	New Zealand
	Norway
	Russia
	Switzerland
	USA

Check all responses that apply

15-DEC-2021

DPO - Question 5/10

Which proposals about the DPO are true?

	The DPO advises on data security
	The DPO provides a data processing contract
	The DPO must be an employee of the company
	The DPO can be external to the company

Check all responses that apply

15-DEC-2021

Data breach - Question 6/10

What are the obligations in the event of a risk-free data breach?

	Document the breach in an internal register
	Notify the breach to the supervisory authority
	Inform the data subject
	Inform the DPO

Check all responses that apply

15-DEC-2021

Serious data breaches - Question 7/10

In the following cases of high-risk data breach, is it mandatory to inform the persons concerned?

	The data controllers do not have any information allowing them to directly contact the persons concerned, but they communicate publicly about the breach
	The data breach is about a small company (less than 10 employees) and contain the salary of each employee but not the name
	The data breach contain passwords for accessing the data, then after being proven that they were not used, the passwords were changed
	An employee manipulated data on his PC in a public place with strangers nearby
	The data is subject to an encryption measure whose key is not compromised and has been generated in such a way that it cannot be found, by any existing technology, by an unauthorized person to use it

Check all responses that apply

15-DEC-2021

DPIA - Question 8/10

Is the "Data Protection Impact Assessment" mandatory in the following cases?

	Data processing relates to genetic patient data
	The data processing is very similar to another data processing for which a DPIA has been done
	The purpose of data processing is to constantly monitor the activity of the Data Subject
	Data processing does not present a high risk for the rights and freedoms of data subjects

Check all responses that apply

15-DEC-2021

Registry - Question 9/10

What should contain the "Records of processing activities"?

	The purposes of data processing
	The list of all subcontractors involved in data processing
	The name and contact details of the data controller
	The data retention time
	The volume of data
	How data are secured

Check all responses that apply

15-DEC-2021

Privacy-by Design - Question 10/10

What are the objectives of Privacy-by Design?

	To ensure that data collection, while authorized, is necessary
	To ensure the protection of data sharing within a company
	To ensure the protection of data throughout the development phase of a new technology
	To ensure the protection of personal data with each new connection to a website

Check all responses that apply

15-DEC-2021

Keep in mind that data privacy is not just important while working, but also when sharing your personal data on social networks or other internet websites!

15-DEC-2021

SAS - CDISC ×

STATISTICS R ×

XXX ×

DATA SECURITY ×

STATISTICS R ×

AI & Animal Health ×

SAS ODS ×

Test your knowledge in Good Clinical Practices! ×

ICH guidelines - Question 1/10

What are the minimum criteria for IRB memberships based on ICH guidelines?

	There must be at least 5 members
	IRB should contain at least 1 scientific member and one non-scientific member
	There is no obligation to have at least 1 member with non-scientific background
	1 member not affiliated with any institution
	No conflict of interest
	Independent of sponsor to provide opinion

Check all responses that apply

23-DEC-2021

FDA guidelines - Question 2/10

What are the minimum criteria for IRB memberships based on ICH guidelines?

	There must be at least 5 members
	IRB should contain at least 1 scientific member and one non-scientific member
	There is no obligation to have at least 1 member with non-scientific background
	1 member not affiliated with any institution
	No conflict of interest
	Independent of sponsor to provide opinion

Check all responses that apply

23-DEC-2021

IRB/IEC responsibilities - Question 3/10

Which of the following statements about responsibilities and composition of the IRB/IEC are true?

	IRB/IEC ensures that the payment to subjects payment to subjects is dependent on completion of the trial by a subject
	IRB/IEC should ensure that information regarding payment to subject is written on the informed consent form
	Investigators participate in the vote and deliberations of the IRB/IEC
	An IRB/IEC may invite non-members with specific expertise for assistance

Check all responses that apply

23-DEC-2021

Serious adverse event - Question 4/10

Which statement about serious adverse event are true?

	An SAE is necessarly either life-threatening or results in death
	An SAE may require long-time hospitalization
	An SAE is a severe disease
	An SAE may result in significant disability

Check all responses that apply

23-DEC-2021

Informed consent - Question 5/10

What should the informed consent document include?

	The fact that the subject’s participation in the trial is voluntary
	The authorisation to make publicly available records that identify the subject
	The way the data of the subject are secured
	The approximate number of subjects involved in the trial

Check all responses that apply

23-DEC-2021

Protocol change - Question 6/10

What conditions are mandatory to make any change to a protocol?

	Prior agreement of the sponsor
	Review and approval of the IRB
	Subjects have given consent
	The trial schedule is unchanged

Check all responses that apply

23-DEC-2021

Representative of a subject - Question 7/10

What conditions are mandatory to conduct a trial with the consent of a legally acceptable representative of a subject (instead of the consent of the subject)?

	The subject has already given his consent for a similar trial
	The approval of the IRB/IEC is requested regarding the inclusion of the subject
	The risk on the subject’s well-being is minimized and low
	The objectives of the trial cannot be achieved with only subjects able to give informed consent personally.
	The trial does not present a high-risk for the rights and freedom of the subject

Check all responses that apply

23-DEC-2021

Care of trial subjects - Question 8/10

Which of the following statements about Medical Care during a clinical trial are true?

	A qualified physician is responsible for all trial-related medical decisions
	The investigator has the obligation to inform the subject’s primary physician about the subject’s participation in the trial
	The subject must provide to the investigator his/her reason(s) for withdrawing prematurely from a trial
	During and following a subject’s participation in a trial, the investigator ensures that adequate medical care is provided to the subject for any adverse event

Check all responses that apply

23-DEC-2021

Sponsor responsibilities - Question 9/10

What are the responsibilities of the sponsor when trial-related duties are transferred to a CRO?

	Trial data quality and integrity
	Quality assurance and control
	Ensuring oversight of any trial-related duty and function performed by the CRO
	Ensure GCP compliance for the duties performed by the CRO
	Any duty and function that has not been specifically transferred to the CRO

Check all responses that apply

23-DEC-2021

CRO responsibilities - Question 10/10

What are the responsibilities of the CRO when trial-related duties are transferred to a CRO ?

	Trial data quality and integrity
	Quality assurance and control
	Ensuring oversight of any trial-related duty and function performed by the CRO
	Ensure GCP compliance for the duties performed by the CRO

Check all responses that apply

23-DEC-2021

Do not hesitate to visit Elsa-Learning, our eLearning platform, next time you need to renew your GCP training!

23-DEC-2021

Merry Christmas! ×

We hope that you enjoyed our videos and quiz during the month of December
Today we have no video for you, but we would like to give you a Christmas present

Do not hesitate to contact us with the code XMAS21 which entitles you

either to a free training module on our Elsa-Learning platform
or to a three-month subscription to our regulatory monitoring application Reglisse

24-DEC-2021