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Pharmacovigilance

Pharmacovigilance

Welcome to the Pharmacovigilance Department of Doctivo Lifesciences. Our commitment to patient safety and efficacy of our products is paramount. As a vital part of our mission, our Pharmacovigilance team diligently monitors, evaluates, and responds to any reports of adverse events associated with our products.

Information received from patients and healthcare providers via pharmacovigilance and medical literature, plays a critical role in providing the data necessary for pharmacovigilance. In fact, in order to market or to test a pharmaceutical product in most countries, adverse event data received by pharmaceutical company is required to be submitted to the local drug regulatory authority.

Thus, pharmacovigilance is concerned with identifying the hazards associated with pharmaceutical products and with minimizing the risk of any harm that may come to patients. Companies must conduct a comprehensive drug safety and pharmacovigilance audit to assess their compliance with worldwide laws, regulations, and guidance

Our team of 10 EU/UK Qualified Persons for Pharmacovigilance (QPPV) and their deputies, as well as over 300 local contact persons responsible for PV (LCPPV) can help you set up and maintain complex global PV systems and participate in non-routine PV activities. Their expertise
spans decades of industry experience, together with in-depth knowledge of industry trends and regulations.

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    What We Do:

    Continuously monitor the safety profile of our products, ensuring they meet the highest standards of safety and efficacy.
    Adhere to global regulatory requirements and collaborate with healthcare professionals, regulatory bodies, and patients to ensure transparent and effective communication.
    Provide healthcare professionals and patients with the necessary information to make informed choices about our products.
    We believe in open communication and prompt response to any safety concerns.
    Collect and analyze data on adverse events, making informed decisions to protect public health
    Engage in ongoing research to improve pharmacovigilance practices and methodologies, staying at the forefront of patient safety.Our Commitment:
    Our priority is the well-being of patients who trust in our products. We are dedicated to ensuring their safety through rigorous monitoring and risk management.
Vigilance on the Safety of Products

As a key factor in the development and use of a medicinal product, Pharmacovigilance includes all the activities aiming at collecting and evaluating information on the safety of drugs, including the suspected adverse reactions. Similar principles and purposes apply to the vigilance of cosmetic products, food supplements and/or medical devices, for which there are specific regulatory requirements which allow the reporting of any adverse events and their evaluation.

Through a continuous review of the safety profile of the medicinal products, the Company may evaluate the implementation of appropriate risk minimization measures and ensures that, provided the authorised terms of use are met, marketed products have a benefit-risk ratio that is favourable for the population.

Hence, pharmacovigilance is essential to better know a drug, to properly inform the physicians who prescribe it and to protect the patients who take it, ensuring it is safely used over time, through a close cooperation among all professionals involved: local, national and international authorities and pharmaceutical companies.

The ultimate goal of pharmacovigilance is an ongoing evaluation of the tolerability profile of a drug throughout its use, from the first clinical trials up to and through the post-marketing stage.

Drugs and Adverse Drug Reactions

Adverse Drug Reaction (ADR) is any response to a drug which is noxious and unintended.

Adverse reactions may arise from use of the product within or outside the terms of the marketing authorisation or from occupational exposure. Use outside the marketing authorisation includes off-label use, overdose, misuse, abuse and medication errors.

What to do in a case of suspected Adverse Drug Reaction

Each country has its own pharmacovigilance rules and legislation to regulate the reporting requirements. Patients and healthcare professionals must refer to national provisions for reporting or may report directly to the Marketing Authorisation Holder (MAH) of the drug that is suspected to have caused the adverse reaction.The MAH will evaluate each safety case report and will notify every report in compliance with the procedures and deadlines provided by applicable laws and regulations.

Before taking any clinical treatment initiative for a suspected adverse reaction, citizens should always consult a physician, providing all the available details about the event and their medical history.