• Feature ArticlesFeature Articles

    Using risk management to support outsourcing activities

    This article outlines organizational risks and benefits with respect to third-party vendors and partnerships in regulatory affairs functions. It also discusses the different controls available to apply an effective risk management program in an organization.   Introduction   The use of contracted or third-party services can be an effective way for organizations to resource projects or programs. This way of working has been a growing trend in business operations, e...
  • Feature ArticlesFeature Articles

    Overview of Annex I, In Vitro Diagnostic Directive and the new In Vitro Diagnostic Regulation

    This article provides an overview of Annex I, Essential Requirements 98/79/EC and helps clarify understanding of the new content of Annex I, General Safety and Performance Requirements. It is aimed at regulatory professionals who will benefit from having knowledge of In Vitro Diagnostic Medical Devices General Requirements and Essential Requirements (ERs) as well as requirements for risk management, software, labeling, self-testing devices and instructions for use. Int...
  • Feature ArticlesFeature Articles

    Organizational Culture and Memory in Managing Risk in the Medical Device Industry

    This article discusses the importance of organizational culture and memory in the medical device industry's risk management practices. The authors cite new data from an academic study and an existing FDA study of medical device industry participants to suggest risk management practices are not often an integral part of a medical device organization's culture although many organizations claim to have a "culture of quality." Introduction According to the Italian Renaissan...
  • Regulatory NewsRegulatory News

    European Regulatory Roundup: EMA to Waive Some Scientific Advice Fees for Accelerated Access Program (9 June 2016)

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news. EMA Posts new Guidance on Changing Risk-Management Plans, Manufacturing Sites The European Medicines Agency (EMA) has posted new guidance on post-authorization changes to risk-management plans (RMPs) and manufacturing sites. EMA, which has adopted the policies in an attempt to simplify processes for marketing authorization holders, explained the implications of the guidance...
  • Feature ArticlesFeature Articles

    Ethics and Risk Management: Lessons from the VW Defeat Device

    This article discusses risk management practices from the automotive industry and what the biomedical industry can learn from recent current events. Biomedical professionals are constantly reminded of ethics and risk management in all roles in the field. The financial impact of an organization failure can be nearly limitless when regulatory and/or legal risks are not mitigated through the quality system. As a profession, it is clearly understood biomedical innovations ...
  • Regulatory NewsRegulatory News

    Pediatric Study Plans: FDA Unveils Revised Draft Guidance

    The US Food and Drug Administration (FDA) on Tuesday released updated draft guidance intended to help pharmaceutical sponsors submit pediatric study plans, including what should be included in the plans and how they should be submitted. This revision, which FDA says was based largely on public comments, includes additional clarifications on the 2013 draft guidance, such as new information on what constitutes a materially incomplete initial pediatric study plan (iPSP), th...
  • Feature ArticlesFeature Articles

    Practical Guidance for Regulatory Professionals on Combination Products

    This article provides an overview of combination products and practical suggestions and strategies for regulatory affairs professionals when developing global submission strategies and contributing to development and design control activities. Combination Products Combining a drug, device or biological product into a new product (frequently called a "combination product") continues to be an important and growing category of therapeutic products. Approximately one-thir...
  • Feature ArticlesFeature Articles

    Post-Marketing Plans: An Often Overlooked Component of FDA Advisory Committee Meeting Discussions

    The article analyzes the proportion of FDA Advisory Committees specifically asked to discuss or vote on issues related to post-approval safety activities. Introduction Preparing effectively for a US Food and Drug Administration (FDA) Advisory Committee meeting requires the sponsor team's anticipation of discussion and voting topics FDA will pose to the advisory panel. Discussion topics and voting questions will influence information the team provides to the panel as w...
  • Feature ArticlesFeature Articles

    Canada and the Orphan Drug Framework--Where Are We Now?

    Canada, one of the few developed countries without an orphan drug policy, is finally in the last stages of developing one. In the past, when queried about the lack of a policy, representatives from the country’s food and drug regulatory agency, Health Canada, stated that physicians could apply to have patients receive a non-approved orphan drug through the Special Access Programme or through clinical studies (if conducted in Canada). For manufacturers of orphan drug...
  • In Transparency Bid, EU Regulators Unleash More Information About Drug Safety Measures

    In the EU, as in the US, regulators often approve medicines along with measures intended to mitigate risks associated with the use of a drug. Background: What's an RMP? The Risk Management Plans (RMPs), as they're called, include information on how to minimize or prevent risk, plans to initiate postmarketing studies on the safety and efficacy of a medicine, studies to measure the effectiveness of risk-mitigation measures, and general information regarding the known r...
  • RAPS' LatestRAPS' Latest

    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,...
  • Feature ArticlesFeature Articles

    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 ...