Pharmacovigilance Services

We offer pharmacovigilance services for human use and veterinary during the study and once marketing authorization is available.

Pharmacovigilance for human use

Veterinary pharmacovigilance

PHARMACOVIGILANCE FOR HUMAN USE

Pharmacovigilance services in Spain, Italy and Portugal

We understand pharmacovigilance as the process of monitoring and evaluating the safety and benefit/risk balance of a medicinal product throughout its lifecycle, both in the clinical phases and in the marketing period.

Likewise, monitoring the safety of medical devices is essential to prevent and reduce the recurrence of incidents related to their use.

How we work at León Research:

We provide a high-quality pharmacovigilance service by creating a specific plan for the safety system to be followed in each study, adapted to the Good Pharmacovigilance Practice Guidelines included in the European Union Legal Framework.

Pharmacovigilance of medicinal products and medical devices safety is carried out under the Good Pharmacovigilance Practices, national legislations and European regulations following the highest quality standards to ensure compliance with safety requirements.

Main Pharmacovigilance Services

European QPPV (Qualified Person responsible for Pharmacovigilance)

Local QPPV in Spain, Italy and Portugal

Responsible Person for Clinical Trials

Serious Adverse Event (SAE) collection, management and assessment

Case Narrative writing

MedDRA coding

Individual Case Safety Report (ICSR) information reporting to EudraVigilance

Preparation and submission of periodic reports (PSUR, DSUR and ASR)

Safety information medical review and evaluation

CIOMS preparation and SUSAR reporting.

Safety information submission to Sponsors

Pharmacovigilance for human use

1 · AUTHORIZED MEDICINAL PRODUCTS (AMP)

Set up and maintenance of the Safety Data Exchange Agreements (SDEA)
Qualified Person Responsible for Pharmacovigilance (QPPV) & Deputy
Local QPPV
24/7 contact for local competent authorities and the company
Creation and maintenance of the Safety Management Plan
Preparation and maintenance of Safety Documents (PSMF, RMP)
MedDRA (Medical Dictionary for Regulatory Activities) coding
Individual Case Safety Report (ICSR) information reporting to EudraVigilance (EV)
Strategy Preparation and local literature searches
Preparation and submission of the Periodic safety update reports (PSURs)

2 · DEVELOPMENT MEDICINAL PRODUCTS (DMP)

Creation and maintenance of the Safety Management Plan
Collection, management and assessment of Serious Adverse Events (SAEs)
Preparation and drafting of safety case narratives
MedDRA coding
Preparation of CIOMS forms and reporting of RAGIs
Creation of the global safety database
Preparation and submission of periodic reports (DSUR))

3 · MEDICAL DEVICES (MD) under development or CE marked

Creation and maintenance of the Security Management Plan
Establishment and maintenance of the Safety Management Plan
Collection, management and assessment of serious adverse events (SAEs)
Writing case narratives
MedDRA coding
Preparation and monitoring of MDCG 2020-10/2
Establishment of the global safety database
Reporting of safety information to Competent Authorities and Independent Ethics Committees (IECs)
Preparation and submission of periodic reports (ASRs)

Contact us for more information

Pharmacovigilance Glossary

ADR (Adverse Drug Reaction)
Any undesirable or unintended effect that occurs with a drug, used in its normal dosage, for which a causal relationship cannot be ruled out.

ADR can be separated from AE by the possible/probable/certain causal relationship.

AESI (The acronym AESI refers to an adverse event of special interest)

AGGREGATE REPORTS

AMP (An Authorised Medicinal Product)

ATC (The Anatomical Therapeutical Chemical system)

CIOMS Form
Standardized document including the minimum required information for the appropriate reporting of adverse drug reactions.

The Council for International Organizations of Medical Sciences (CIOMS) create this Form with the purpose of providing an international reference to unify the reporting procedure between different countries.

Different national and international regulatory authorities have created their own reports based on the CIOMS Form I, firstly established in 1987.

COMPLIANCE ON PHARMACOVIGILANCE

DEPUTY QPPV (Qualified Person Responsible for Pharmacovigilance)

DRUG SAFETY

EUDRAVIGILANCE

FDA COMPLIANCE

GLOBAL SAFETY DATABASE
Means a database where it is collected all the Adverse Events, Serious Adverse Events, Serious Adverse Drug Reactions, and pregnancy report occurred during a clinical Trials or in case of Authorised Medicinal Product, all the adverse events reported directly by a health care professionals or users to the Marketing Authorisation Holder or Competent Authority website (special tab for this purpose).

ICSR

LOCAL RESPONSIBLE FOR PHARMACOVIGILANCE (LRPV)
Is the person responsible for some or all (if required by the country specifications), of the pharmacovigilance tasks in a country or territory.

For some territories, this person needs to be formally nominated.

Unless defined otherwise, this person should have a university degree in natural sciences or human/veterinary medicine to be habilitated to act as a responsible person for pharmacovigilance activities.

MARKETING AUTHORIZATION HOLDER (MAH)
Refers to the individual, company, institution, organization or other legal entity in whose name the marketing authorization has been granted.

The marketing authorization may have been granted for a medicine in one, several or all European Union Member States.

The MAH is the responsible for all aspects of the product, including quality and compliance with the conditions of marketing authorization.

MEDDEVs

MEDICATION ERROR

MEDICATION INTERACTION
Refers to any interaction with the medication, and may be classified by the interaction agent itself:

Drug-drug interactions: These are the most common type of drug interaction. The more medications and types of medications you take, the greater the chance for your drug interacting with another medicine. Drug-drug interactions can decrease how well your medications work, may increase minor or serious unexpected side effects, or even increase the blood level and possible toxicity of a certain drug.

Drug-food/beverage interactions: Certain medications can interact with foods or beverages.

Drug-disease interactions: Existing medical condition can affect the way a drug works.

OFF-LABEL

PERIODIC BENEFIT RISK EVALUATION REPORT (PBRER)

PHARMACOVIGILANCE
From the etymological perspective, pharmacovigilance can be divided into two words, pharmaco from the greek “pharmakon” meaning drug and vigilance from the latin “vigilare” meaning to keep watch.

So in general terms, pharmacovigilance is the process to keep a continued vigilance over the marketed and unmarketed (under clinical trials) medicinal products in order to detect, assess, understand and prevent adverse reactions.

PRAC

PSMF

PSUR (THE PERIODIC SAFETY UPDATE REPORT)

QUALIFIED PERSON RESPONSIBLE FOR PHARMACOVIGILANCE (QPPV)

REGULATORY AFFAIRS (RA)
Regulatory affairs professionals (aka regulatory professionals) usually have responsibility for the following general areas:

Ensuring that the company complies with all of the relevant for the company regulations and lawsand assisting with/performing all regulatory submissions and notifications.

Working with country and local regulatory (competent and ethics) agencies and personnel on specific issues that may arise.

RISK MANAGEMENT PLAN

SAE
The acronym SAE refers to a serious adverse event, which is defined as any noxious medical occurrence associated with the use of a pharmaceutical product that is life-threatening or is considered a medically important event or can cause persistent/significant disability, birth defect, hospitalisation, or prolong an existent hospitalisation, or ultimately results in death.

Please note that SAE does not necessarily need to be considered drug-related.

SAFETY MANAGEMENT PLAN
It is the procedure created to regulate all safety communication between the Sponsor and the Contract Research Organizations (CROs).

This procedure ensures the safety reporting of serious adverse events to sites, institutional review boards (IRB) and competent authorities is performed correctly, timely and accordingly with the regulatory requisites.

It also ensures the integrity of the clinical study results and the use of the authorized medicinal products.

SDEA (Safety Data Exchange Agreement)
Written legal agreement between the Marketing Authorization Holder and any subcontractor (pharmacovigilance, manufacturer, licensing partners) that assure any safety information concerning licensed medicinal products will be reported to the MAH so legal reporting requirements can be met.

For pharmacovigilance subcontractors, within this agreement, responsibilities concerning pharmacovigilance activities are clearly stated, granting that an appropriate pharmacovigilance system is in place and that all legal requirements are fulfilled.

SIGNAL DETECTION

SIGNAL
Information provided by marketing experience, investigations or different sources that suggest a plausible causal relationship, or provide new information on a previously known relationship, between a medicinal product and an event, both adverse or beneficial.

Safety signals are especially relevant as they can lead to new medicinal product risk identification so depending on its seriousness and frequency, further MAH actions may be required to confirm the hypothesis.

SUSAR (Suspected Unexpected Serious Adverse Reaction)
This term is used in clinical trials to refers to a serious adverse reaction, i.e. any untoward medical occurrence that results in death, is life-threatening, causes persistent or significant disability, congenital anomaly, hospitalization, or prolonged an existing hospitalization, and that was reported as having a reasonable causal relationship with the experimental medicinal product and is not listed in the applicable product information.

USADE (Unanticipated Serious Adverse Device Effect)

VETERINARY PHARMACOVIGILANCE

Veterinary Pharmacovigilance

We understand veterinary pharmacovigilance as the science and activities related to the detection, evaluation, understanding, and prevention of suspected adverse events or any other problem related to a veterinary drug.

At León Research we provide a high-quality pharmacovigilance service in each study, creating a specific plan for the safety system to be followed for each project, adapted to the Guides for Good Pharmacovigilance Practices included in the legal framework of the European Union 2019/6, which entered into force on January 28, 2022.

Main veterinary pharmacovigilance services

Veterinary QPPV in Europe

Preparation and maintenance of the PSMF

Risk management plan including signal detection

Record of adverse events in EVVET

Adverse event reports

Literature research

Management and internal audits of the PV quality management system

Training plan in PV

How can León Research help veterinary health professionals?

Preparation of the Pharmacovigilance System Master File (PSMF)
Initial training on PMSF management
Pharmacovigilance System Master Plan Maintenance
Initial registration of suspected adverse events and additional data collection
Preparation of reports of adverse events and additional data to present to the health authorities
Assessment of causality in all adverse events
Carrying out internal audits of the Pharmacovigilance system
Monitoring of the quality, integrity and content of the information registered in the pharmacovigilance system, including the information reported to the European Union Database (EVVET) and search for duplicates.

Record of adverse events in EVVET
Document management and archiving system for relevant documentation
Risk Management Plan: including signal detection, continuous benefit/risk monitoring and a communication plan
Pharmacovigilance training plan for all personnel involved in the commercial, quality, distribution, auxiliary personnel, etc.
Literature research
Preparation of a model agreement on pharmacovigilance with drug distribution entities (commercial veterinary distributors)

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Pharmacovigilance Services

PHARMACOVIGILANCE FOR HUMAN USE

Pharmacovigilance services in Spain, Italy and Portugal

How we work at León Research:

Main Pharmacovigilance Services

Pharmacovigilance for human use

1 · AUTHORIZED MEDICINAL PRODUCTS (AMP)

2 · DEVELOPMENT MEDICINAL PRODUCTS (DMP)

3 · MEDICAL DEVICES (MD) under development or CE marked

Contact us for more information

Pharmacovigilance Glossary

VETERINARY PHARMACOVIGILANCE

Veterinary Pharmacovigilance

Main veterinary pharmacovigilance services

How can León Research help veterinary health professionals?

Contact us for more information