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LeonResearch.Pharmacovigilance

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 products 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.

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HOW WE WORK AT LEON RESEARCH

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We provide a high-quality pharmacovigilance service by creating an specific planning 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 are 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

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  • 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

  • Safety information medical review and evaluation

  • CIOMS preparation and SUSAR reporting.

  • Safety information submission to Sponsors

  • Individual Case Safety Report (ICSR) information reporting to EudraVigilance

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

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    PHARMACOVIGILANCE GLOSSARY

    Pharmacovigilance glossary

    ALL PHARMACOVIGILANCE SERVICES

    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)

    DEVELOPMENT MEDICINAL PRODUCTS (DMP)

    • Creation and maintenance of the Safety Management Plan

    • Serious Adverse Event (SAE) collection, management and assessment

    • Case Narrative writing

    • MedDRA coding

    • CIOMS preparation and SUSAR reporting

    • Creation of the global safety database

    • Preparation and submission of periodic reports (DSUR)

    MEDICAL DEVICES (MD)

    • Creation and maintenance of the Safety Management Plan

    • Serious Adverse Event (SAE) collection, management and assessment

    • Case Narrative writing

    • MedDRA coding

    • MDCG 2020-10/2 preparation and follow up

    • Creation of the global safety database

    • Safety information reporting to CAs and IRBs

    • Preparation and submission of periodic reports (DSURs/ASR)

    Ready to work together?

    Leon Research is a pharmaceutical services provider based in Spain, Italy and Portugal

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