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    EU regulators set network strategy to 2025

    The European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) have adopted their next five-year network strategy following its adoption by the EMA’s management board and HMA.   The 53-page strategy, which was released for consultation in July, focuses on six priority areas for the network of regulators:   availability and accessibility of medicines; data analytics, digital tools and digital transformation; innovation; antimicrobial resistance an...
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    RAPS’ updated book on regulatory strategy for devices serves as ‘how to’ guide

    Constant innovation in medical technology, globalization, pressure on medical device makers to control costs and demonstrate clear benefits to patients, and increased scrutiny from regulators make having a sound regulatory strategy more critical than ever. The recently released second edition of RAPS’ Global Medical Device Regulatory Strategy book provides a “how to" guide to developing a comprehensive regulatory strategy for bringing all types of devices to the global...
  • 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...
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    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...
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    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...
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    Reassessing Benefit-Risk: FDA Preps for New Guidance

    US Food and Drug Administration (FDA) and pharmaceutical industry experts gathered Thursday in Silver Spring, MD, to discuss how FDA assesses the benefits and risks of new drugs from the preclinical to postmarket phases. The meeting was conducted as part of FDA preparations in drafting new guidance in FY 2020 on the benefit-risk assessment of new drugs and biologics. Theresa Mullin, associate director for strategic initiatives at FDA’s Center for Drug Evaluation and ...
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    Risk-Based Monitoring: Pfizer and BMS Seek Clarity on FDA Draft Guidance

    Pfizer and Bristol-Myers Squibb (BMS) recently raised questions with and sought further clarity from the US Food and Drug Administration (FDA) on a draft guidance related to the risk-based monitoring (RBM) of clinical trials. The eight-page RBM draft guidance , released in March, comes in the form of eight questions and answers. It expands on guidance from August 2013, known as “ Oversight of Clinical Investigations--A Risk-Based Approach to Monitoring ,” by providing...
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    Industry Calls for Changes in Two REMS Guidances

    Industry groups representing the pharmaceutical, biotechnology and generic drug industries are calling for changes to two recent US Food and Drug Administration (FDA) draft guidances on risk evaluation and mitigation strategies (REMS).   The draft guidances , released for comment in January, detail a framework for companies to develop an assessment plan for their REMS programs and provide recommendations for surveying patient and health care provider knowledge of REMS...
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    FDA Modifies REMS Program for Clozapine

    The US Food and Drug Administration (FDA) announced changes to its risk evaluation and mitigation strategy (REMS) for the antipsychotic drug clozapine, set to take effect on 28 February 2019.   Background   Clozapine, which is marketed as Clozaril, Fazaclo ODT and Versacloz, is an antipsychotic drug first developed in the late 1950s and was first approved by FDA in 1989. Clozapine is indicated for the treatment of schizophrenia in patients whose symptoms are not ad...
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    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...
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    Are You a Rising Regulatory Leader? Learn Business Skills at RAPS Executive Development Program

    As William C. Putnam, PhD, RAC, argues in a  Regulatory Focus  thought piece  on the need for business skills within the regulatory profession, "regulatory professionals need to have a comprehensive understanding of business, such as the business acumen provided by extensive on-the-job training, professional development programs or formal business training."  Regulatory Strategy Critical for Business Success The reasons for this are pretty clear. Regulatory issues can ...
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    Why Regulatory Professionals Need Business Training

    You are the senior regulatory professional in the board room overseeing a major development program. The program looks promising and all you need to be concerned about is the most expeditious and risk-free regulatory path to approval, right? Unfortunately, that is not the case. The regulatory development path is typically much more complex and there are many business factors that drive the ultimate development strategy design. The most successful development programs tak...