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  • Feature ArticlesFeature Articles

    Risk management, drug shortages and the EU portal for clinical trials

    Feature articles during May focused on risk management and mitigation in dealing with contractors and vendors and included articles on best practices in good vendor management, use of risk management to support outsourcing activities, testing in-house versus outsourcing, and outsourcing in regulatory operations. Also included were in-depth examinations of challenges and opportunities in “bespoke” therapies, a critical appraisal of drug shortages in Germany and an update on...
  • Feature ArticlesFeature Articles

    A guide to good vendor management

    This article addresses best practices for regulatory affairs departments in their work with vendors. The author provides an overview of the vendor-contract giver relationship, then discusses finding an appropriate vendor, due diligence in selecting a vendor, vendor-related risk management, contract management, performance evaluation, maintaining the vendor-contract giver relationship, and the importance of follow-up meetings, audits, and reviews.   Introduction   A...
  • 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...
  • Regulatory NewsRegulatory News

    EU Regulatory Roundup: EMA shares advice on validated computer systems used in clinical trials

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news.   EMA shares advice on validated computerized systems used in clinical trials   The European Medicines Agency (EMA) has published a notice about validating and qualifying all types of computerized systems used in clinical trials. EMA released the notice in response to “recent inspection findings” and their implications for the “integrity, reliability, robustness and accep...
  • ReconRecon

    Recon: Abbott beats quarterly profit estimates; UK approves Penlon ventilator for COVID-19

    Editor’s note: Regulatory Recon will be undergoing some changes in the coming weeks as we fine tune its content and presentation to better align with the topics and industries it covers. We value your input as we adapt Recon going forward. Please write to news@raps.org if you have any comments or suggestions.   In Focus: US Chaotic search for coronavirus treatments undermines efforts, experts say ( Washington Post ) House Speaker Pelosi calls Trump WHO decision sen...
  • ReconRecon

    Recon: Merck launches trastuzumab biosimilar in US; Fujifilm boosts Avigan production

    Editor’s note: Regulatory Recon will be undergoing some changes in the coming weeks as we fine tune its content and presentation to better align with the topics and industries it covers. We value your input as we adapt Recon going forward. Please write to news@raps.org if you have any comments or suggestions.   In Focus: US Coronavirus testing hits dramatic slowdown in US ( Politico ) Trump's halt to WHO funding prompts condemnation as coronavirus cases near 2 mill...
  • ReconRecon

    Recon: GSK, Sanofi team up for coronavirus vaccine; India to boost domestic API production

    Editor’s note: Regulatory Recon will be undergoing some changes in the coming weeks as we fine tune its content and presentation to better align with the topics and industries it covers. We value your input as we adapt Recon going forward. Please write to news@raps.org if you have any comments or suggestions.   In Focus: US Trump: It's my decision when to reopen US economy ( Reuters ) ( NPR ) NY, CA and other states plan for reopening as coronavirus crisis eases ( ...
  • Regulatory NewsRegulatory News
    TrackersTrackers

    The Essential List of Regulatory Authorities in Asia

    To ease the process of finding drug and medical device regulators in Asia and Oceania, Focus has updated its list of the website(s) for each country’s ministry of health and regulatory authority. The list also notes the country’s membership in regional organizations that have a regulatory component.   For countries that do not list a regulatory authority, regulatory functions are either performed by the ministry of health, or the information available online was unc...
  • Regulatory NewsRegulatory News

    EMA Staff Losses Tick Up as Workload Increases

    As the interim arrangements to allow European Medicines Agency (EMA) staff to telework from London have now ended, the agency said its total available workforce in Amsterdam is about 730, which is about 20% less than the 900 staffers EMA had in London. “Due to these ongoing resource constraints, delivery of EMA’s work programme for Q4 2019 will be challenging for the Agency, particularly in view of the need to implement new legislation for veterinary medicines and medic...
  • Regulatory NewsRegulatory News

    IMDRF Offers New Guidance on Cybersecurity

    In its first guidance document to deal exclusively with the cybersecurity of medical devices, the International Medical Device Regulators Forum (IMDRF) this week released new general principles and best practices to facilitate better international regulatory convergence on the topic. The 45-page guidance document, developed by a working group led by officials from the US Food and Drug Administration (FDA) and Health Canada, includes both pre-market and post-market cyber...
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    RAPS AnnouncementsRAPS Announcements

    RAPS Honors Winners of Founder’s Award, Community Leadership Award and New Patient-Centered Health Award

    RAPS today recognized five distinguished individuals and one leading advocacy organization for contributions to the regulatory profession and to promoting public health.   “The Founder’s Award is RAPS’ highest honor,” said RAPS Executive Director Paul Brooks. “It recognizes exemplary professionals who have had a substantial and sustained impact over the course of their careers, shaping regulatory policy and practice, and advancing the regulatory profession.”   The ...
  • Regulatory NewsRegulatory News

    APEC Members See Increased Regulatory Convergence

    Countries involved in the Asia-Pacific Economic Cooperation (APEC) are better aligning their regulatory schemes related to drugs and medical devices, according to a new survey unveiled Monday at an APEC meeting in Chile. The survey shows how between 2008 and 2019, APEC countries are seeing modest increases in: Sharing information (from 16 APEC economies to 19 economies) Establishing confidentiality commitments (from 12 economies to 15) Sharing good manufacturing pr...