• Regulatory NewsRegulatory News

    EMA Begins Pharmacovigilance Training Courses

    The European Medicines Agency (EMA) this week began running a series of pharmacovigilance training sessions to help companies and regulators meet their obligations when using EudraVigilance, a centralized European database of suspected adverse reactions to medicines in the European Economic Area (EEA). At least one user from each national competent authority, marketing-authorization holder or sponsor of clinical trials in the EEA should complete the training to ensure th...
  • Regulatory NewsRegulatory News

    European Regulatory Roundup: EMA Proposes Major Changes to Risk Management (3 March 2016)

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news. EMA Proposes Major Changes to Pharmacovigilance Risk Management System Guidelines The European Medicines Agency (EMA) has proposed major changes to its good pharmacovigilance practices (GVP) module on risk management systems. EMA wants to implement the modifications to bring the guidelines in line with its current thinking, which has evolved over the past three years as it ...
  • Regulatory NewsRegulatory News

    EU MAHs Will See Relief on Some Pharmacovigilance Updates

    Beginning 1 February, drug companies operating in the EU will only have to update a database for some pharmacovigilance changes and will no longer have to submit a particular IA variation to the European Medicines Agency (EMA). According to the update from the European Commission on Friday, marketing authorization holders (MAH) have to inform competent authorities about changes to the Qualified Person responsible for Pharmacovigilance (QPPV) including contact details and...
  • Regulatory NewsRegulatory News

    European Regulatory Roundup: EMA Revises Conflict of Interest Rules for Board Members (21 January 2016)

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news. PRAC Adopts Strategy to Monitor Effects of Risk-Minimization Measures The Pharmacovigilance Risk Assessment Committee (PRAC) has implemented a strategy to enable it to measure the impact of its activities. Officials have designed the strategy to deliver feedback on the effectiveness of risk-minimization measures and other actions. PRAC, a part of the European Medicines Agen...
  • Regulatory NewsRegulatory News

    European Commission to Evaluate EMA’s Fee System

    Late next year, the European Commission will begin reviewing the pharmaceutical company fee system that helps fund the European Medicines Agency (EMA). “The effectiveness and the efficiency of the system will be examined notably with respect to the sustainability and the fairness of the financial model of the fees charged by EMA to industry at large, including the remuneration paid by EMA to rapporteurs and experts from national competent authorities,” the commission sai...
  • Regulatory NewsRegulatory News

    European Regulatory Roundup: EMA Offers New Pharmacovigilance Updates (17 December 2015)

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news. EMA Releases More Pharmacovigilance Documents The European Medicines Agency (EMA) has released a batch of draft pharmacovigilance documents. EMA covers multiple aspects of good pharmacovigilance practice (GVP) in the texts, from changes to a template for direct healthcare professional (HCP) communication, to tweaks to a biologics-focused document. In total, EMA pub...
  • Regulatory NewsRegulatory News

    EMA Committee Finds No Link Between HPV Vaccines and Rare Conditions

    After reviewing the safety profile of human papillomavirus (HPV) vaccines, a European Medicines Agency's (EMA) committee found no evidence the vaccines cause two rare conditions in young women, concluding that "there is no reason to change the way the vaccines are used." PRAC Review There are currently three centrally-authorized HPV vaccines in the EU – Gardasil/Silgard, Gardasil 9 and Cervarix – to protect against cervical cancer and other HPV related conditions. Upon...
  • Feature ArticlesFeature Articles

    Bringing Structure to Substance Information

    This article discusses compliance challenges pharmaceutical companies face with the International Organization for Standardization (ISO) Identification of Medicinal Products (IDMP) standard for structured substance information. To support continuous pharmacovigilance oversight improvement within the EU, the European Commission has mandated pharmaceutical companies’ adherence to ISO IDMP standards by 1 July 2016 . 1 These standards collectively outline the data ...
  • Feature ArticlesFeature Articles

    Managing Pharmacovigilance in Digital Health Initiatives

    • 14 August 2015
    This article analyzes adverse event reporting obligations and identifies ways to reduce regulatory risk and cost associated with digital health initiatives. The pharmaceutical industry, most would agree, has been slow to embrace the use of digital technologies, such as the cloud and mobile devices, in delivering healthcare. As with social media, pharmaceutical company involvement in digital health presents many difficult questions, making executives uneasy. Among...
  • Regulatory NewsRegulatory News

    MHRA to Pilot Stand-Alone Pharmacovigilance Inspections for Contractors

    The UK's Medicines and Healthcare Products Regulatory Agency (MHRA) is considering conducting "stand-alone" inspections of companies that conduct pharmacovigilance activities on a contractual basis for drugmakers. Background Pharmacovigilance is the process of monitoring the use of drugs after they have entered the market. In particular, regulators, companies and healthcare providers are responsible for monitoring drugs and reporting suspected adverse events. This infor...
  • Regulatory NewsRegulatory News

    EMA Updates Two Pharmacovigilance Guidelines

    Today, the European Medicines Agency (EMA) released two revised guidelines, one final and one draft, to clarify certain aspects of pharmacovigilance in the EU. The two guidelines include a draft version of Module VIII – Post-Authorisation Safety Studies (Rev 2) , which is expected to come into effect in early 2016, and Module IV – Pharmacovigilance Audits (Rev 1) , which takes effect on 12 August 2015. Background Pharmacovigilance is the process of monitoring the use...
  • Regulatory NewsRegulatory News

    FDA and Google Talk 'Adverse Event Trending'

    Last month, representatives from the US Food and Drug Administration (FDA) and search giant Google met to discuss "adverse event trending," Bloomberg reports. Background Currently, FDA keeps track of adverse events submitted through voluntary and mandatory reports to its FDA Adverse Event Reporting System (FAERS). Drugmakers are required to report adverse events to the agency; however, patients and their doctors do so voluntarily, leading to serious underreporting. ...