• EMA Management Board Turns Focus to Regulatory Science and Faster Approvals

    In its first meeting of 2013, the European Medicines Agency's (EMA) management board turned its sights on the agency's use of regulatory science, saying EU regulators need to adopt new approaches to allow for drugs to get to patients more quickly and with a better understanding of patients' tolerance for risk-a potential boon for members of rare patient populations. In a statement, EMA said the board has already turned its attention-much as the US Food and Drug Administr...
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    Book Excerpt: Risk Management in the Future: Looking Into the Crystal Ball

    Chapter 15 Pharmacovigilance has been defined by the World Health Organization as, "The science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem." 1 Pharmacovigilance (or risk management) should help to inform both healthcare professionals and patients, allowing them to make educated decisions when choosing a treatment. 2 The main methods for pharmacovigilance are randomized trials,...
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    Risk Management for Medical Devices - A Practical Approach

    Imagine yourself in this situation: you just started working for a new company and you review the risk management file you need to include in the next device submission, which, by the way, is urgent. You have a look at the Design History File (DHF). There is an FMEA you hope is up-to-date; a risk management plan that unfortunately lacks typical deliverables and a method for systematically tying together risks, hazards, requirements, controls, verification and validation ...
  • EU:European Commission Opens Review of Variations Guidance

    The European Commission has opened a public consultation on proposed changes to the current guidance on making changes to the terms of approved marketing authorizations, otherwise known as the "Variations Regulation." The document takes into account scientific and technical progress since the entry into force of guidelines in January 2010 and addresses an update required by the implementation of the new Pharmacovigilance legislation, which will enter into force in July...
  • New Transparency Standards Now in Place for EMA's Management Board

    The European Medicines Agency (EMA) is on a transparency kick. After coming under unrelenting pressure from the European Parliament (EP) and other stakeholders over perceived opaqueness at the agency, EMA has recently moved to roll out a number of initiatives it says it hopes will reverse the notion that it is a closed agency. Now, its transparency efforts are going right to the top. In an announcement made 8 June, EMA said its Management Board will now be subject to...
  • Report: REMS Preventing Companies From Making Generic Medicines

    The Food and Drug Administration (FDA) Amendments Act of 2007 allowed FDA to institute risk management plans-known as Risk Evaluation and Mitigation Strategies (REMS)-for products with a high probability of misuse or dangerous side effects. Now, manufacturers of generic medicines are claiming a side effect of the REMS policy is just as dangerous: restrictive REMS policies are preventing them from obtaining samples of medicines they need to make generic copies. The ...
  • GHTF Proposes New Harmonization of Medical Device Audits

    The Global Harmonization Task Force ( GHTF ), a medical device-focused regulatory harmonization organization which counts among its members many of the world's top regulatory agencies, announced a new proposed medical device standard aimed at introducing a grading system to be used during regulatory audits by regulatory authorities and auditing organizations. The proposed document, SG3(PD)/N19: Quality Management System - Medical Devices - Nonconformity Grading System ...
  • EMA Tightens Conflict-of-Interest Policies

    The European Medicines Agency (EMA) announced it will, effective immediately, be tightening its conflict-on-interest policies for scientific experts and members of advisory committees. The policy was announced 3 April after being endorsed by EMA's Management Board on 22 March 2012. "The updated policy gives clearer guidance on the involvement of experts in academic trials and publicly funded research," explained EMA in a statement. "It aligns restrictions for the differ...
  • EMA Strengthens Conflict of Interest Policies

    The European Medicines Agency (EMA) announced Monday, 26 March its Management Board has endorsed a proposal from EMA Executive Director Guido Rasi to strengthen conflict of interest policies surrounding its scientific committee members and experts. The Management Board also adopted several other initiatives, including a transparency initiative to "increase the transparency of all pharmacovigilance activities of the Agency and national authorities" while implementing the ...