• Feature ArticlesFeature Articles

    MDR, IVDR, and compliance: A guide for distributors

    Distributors must prepare for new incoming requirements under EU medical device and in vitro diagnostic device regulations. The importance of establishing an effective quality management system, drafting comprehensive contractual agreements and, if required, engaging notified bodies, has created much uncertainty for distributors. To fulfil these new requirements and maintain device supply chains, it is essential for distributors to act early, ensure sufficient in-house com...
  • 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

    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

    Experts Tell Device Companies Not to Fret Over QMS Transition

    Ahead of the proposed shift away from the current US Food and Drug Administration (FDA) quality management system (QMS) CFR 21 Part 820 regulation toward ISO 13485:2016, a new white paper sheds light on how the action will impact medical device development. The white paper identified three interrelated principles that will define the direction of the agency’s process, which has yet to be clearly defined, after the transition . These principles relate to the concept of ...
  • Regulatory NewsRegulatory News

    WHO Consults on QMS Guideline for Regulators

    The World Health Organization (WHO) in January released for consultation a draft of its upcoming guideline on implementing quality management systems (QMS) for national regulatory authorities (NRAs).   Specifically, the 96-page draft guideline is meant to fill the gaps for NRAs looking to implement a QMS based on the International Organization for Standardization’s (ISO) 9001:2015 Quality Management Systems – Requirements standard, as other existing QMS guidelines do n...
  • Regulatory NewsRegulatory News

    Industry Comments on ICH Product Lifecycle Management Guideline

    The European Medicines Agency (EMA) on Friday released comments gathered during its public consultation for the International Council for Harmonisation's (ICH) draft guideline on pharmaceutical product lifecycle management.   The 31-page draft guideline , ICH Q12: Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management , was adopted by ICH and released for public consultation last year.   Most of the comments EMA received express...
  • RAPS' LatestRAPS' Latest

    Risk Management: What Regulatory Professionals Need to Know

    For companies looking to develop new therapies or improve existing ones, and for the regulators overseeing them, striking right balance between potential benefits to patients and an appropriate level of risk is critical. The drive to innovate, develop new and better products, and help patients live healthier lives has led to numerous medical breakthroughs. But it is just as imperative that products are as safe as possible, and that where there are associated risks, they a...
  • Feature ArticlesFeature Articles

    Preparing for and Managing FDA Inspections

    The article discusses best practices for a manufacturer to stay 'inspection ready' on a day-to-day basis with a focus on how to prepare for and successfully manage FDA inspections from start to finish. Introduction For pharmaceutical manufacturers, US Food and Drug Administration (FDA) inspections are an occasional part of being in business and perhaps a fact-of-life. While FDA is required to inspect drug manufacturing facilities every two years, the agency is also au...
  • 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...
  • Regulatory NewsRegulatory News

    MDSAP Changes Aim to Reduce Audit Times

    With an eye on a 1 January 2019 deadline for transitioning to only Medical Device Single Audit Program (MDSAP) quality management system certificates accepted for medical device license applications by Health Canada, the MDSAP consortium has implemented a couple of changes to speed up audits. The changes follow comments received by Health Canada from Canadian medical device license holders regarding the current audit-time model for MDSAP and subsequent annual survei...