Vigilance services

We offer Vigilance Services through life cycle of products

Clinical Research and Development

Clinical safety management of medicinal products, medical devices, and food supplements.

Registration and Marketing Application

Development of safety documents required for marketing application supplements.

Post-marketing

GVP assurance and safety control across your product’s lifetime supplements.

VIGILANCE SERVICES

Vigilance activities in Spain, Italy and Portugal, and with the possibility of carrying out activities in other countries through the Leon Research network.

We understand vigilance as the process of monitoring and evaluating the safety and benefit-risk balance of products throughout their life cycle, including the clinical phases and the marketing phase.

Similarly, 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 vigilance service by creating a specific plan for the safety system to be followed in each project, adapted to the Good Pharmacovigilance Practice guidelines included in the European Union Legal Framework, following the highest quality standards to ensure compliance with safety requirements.

Main Vigilance Services

EU-QPPV

Local QPPV in Spain, Italy and Portugal

EV Responsible Person for Clinical Trials

Case processing and narrative writing

Global and Local Scientific Literature searches

ICSR and SUSAR reporting to EudraVigilance

Safety and medical writing

Preparation of aggegated reports (PSUR, DSUR and ASR)

Pharmacovigilance of radiopharmaceuticals

Pharmacovigilance of veterinary medicines

CLINICAL RESEARCH AND
DEVELOPMENT

EV Responsible Person
Creation and maintenance of the Safety Management Plan
Case Processing including narrative and medical review
CIOMS forms preparation and SUSAR reporting
Creation and maintenance of the global safety database
Preparation and submission of DSUR

REGISTRATION AND MARKETING
APPLICATION

Prepare PV system, including PSMF
Risk-management System
EU-QPPV
Support for Marketing Authorization Applications (MAA)
Prepare in regulator-ready dossiers
Coordinate with Competent Authorities

POST-MARKETING

Creation and maintenance of PV Agreement
EU-QPPV and Deputy
Local PV Support
PSM and PV Agreement
ICSR reporting
Global and Local Scientific Literature searches
Aggregate Safety Reports
Signal management
Regulatory intelligence
Quality system, SOPs and Audits

Vigilance Services Glossary

ADR (Adverse Drug Reaction)

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

AGGREGATE REPORTS

AMP (Authorised Medicinal Product)

ATC (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.

MEDDEVs

MEDICATION ERROR

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.

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.

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)

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