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Pharmacovigilance Services Under EMA Guidelines

Pharmacovigilance is a critical aspect of the healthcare system, focusing on the detection, assessment, understanding, and prevention of adverse effects or any other drug-related problems. Under the European Medicines Agency (EMA) guidelines, pharmacovigilance activities are structured to ensure the highest standards of patient safety and drug efficacy.

EMA

Role of the European Medicines Agency (EMA)

The EMA is a decentralized agency of the European Union (EU), responsible for the scientific evaluation, supervision, and safety monitoring of medicines in the EU. The agency’s pharmacovigilance responsibilities include:

  • Centralized Reporting System: EMA manages EudraVigilance, a centralized database for collecting reports of suspected adverse reactions.
  • Scientific Committees: The Pharmacovigilance Risk Assessment Committee (PRAC) is responsible for assessing and monitoring the safety of human medicines.
  • Guidelines and Regulations: EMA develops guidelines for good pharmacovigilance practices (GVP) to standardize the procedures and requirements across the EU.
  • Coordination and Communication: EMA coordinates with national pharmacovigilance centers and communicates safety information to healthcare professionals and the public.

Ensuring Compliance and Quality

To maintain high standards of pharmacovigilance, EMA conducts regular inspections of pharmaceutical companies and other stakeholders. These inspections assess compliance with GVP guidelines and other regulatory requirements. Non-compliance can result in corrective actions, including fines and product recalls.

Public Health and Communication

EMA places a strong emphasis on transparency and communication. The agency regularly publishes safety communications, including updates on ongoing safety reviews, newly identified risks, and changes to product information. This ensures that healthcare professionals and patients are well-informed about the benefits and risks of medicines.

EMA

Expertise and Experience

Our team of highly qualified professionals has extensive experience in pharmacovigilance across various therapeutic areas and Services

Regulatory Compliance

We ensure strict adherence to global regulatory requirements, including FDA, EMA, health Canada, CDSCO, MHRA guidance

Customized Solutions

We offer tailored pharmacovigilance solutions to meet the unique needs of each client, ensuring optimal outcomes.

Global Reach

With a network of partners and affiliates worldwide, we provide comprehensive pharmacovigilance services across all major markets.