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    Cybersecurity, Regulatory Intelligence, Software as a Medical Device and Data Integrity Failures

    Feature articles throughout May examined global regulatory compliance and enforcement issues, including FDA’s review framework for medical devices, global cybersecurity compliance and a process for communicating with China's Center of Drug Evaluation (CDE) during drug development. Other articles explored Regenerative Medicine Advanced Therapy (RMAT) designations, changes in guidance documents, new legislation and helpful regulatory intelligence tools. Experts also provided...
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    Biosimilars, Regulatory Science, Cell and Gene Therapy Guidance and China’s Regulatory Landscape

    April features took an in-depth look at biosimilars from a global perspective, the need to update regulatory science to include the use of Minimal Residual Disease (MRD), recent changes to China’s healthcare regulatory authorities and healthcare policy administration and the importance for manufacturers and regulators to ensure manufacturing controls are in place to sustainably produce regenerative medicines.   Biosimilars   Gowri Sukumar focuses on global regulati...
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    Working with Other Markets: Pathways, Submissions and Strategies

    Feature articles in March explored working with other markets including global regulatory pathways in China, Japan and New Zealand, the regulation of animal drugs and veterinary medical devices and the complex regulatory pathway for drugs to treat orphan/rare pediatric diseases. Other articles explored risk management and medial device software.   Global Regulatory Pathways   Senior regulatory consultant, Yingying Liu , discusses Chinese pharmaceutical regulatory...
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    Global Guidance, Medical Device Technology and Regulatory Intelligence

    February feature articles covered medical device technology challenges, artificial intelligence applications and regulatory intelligence strategy. Global experts also shared their experience on labeling activities for drugs and biologics, the future of the laboratory developed test (LDT) regulation, China’s new drug and device inspection regulations and new guidance for oncology drug development. Medical Device Technology Regulatory experts Stephen Amato and Net...
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    Regulatory Intelligence, Risk Management and Drug Promotion

    Feature articles over the past weeks covered strategies for regulatory intelligence communication and management, the need for quality, relevant and timely intelligence and the importance of regulatory intelligence when preparing for meetings with FDA and other global regulators. Articles also covered emerging trends in risk management, risk evaluation and mitigation strategy and the changing landscape of drug promotion. Regulatory Intelligence   To stay current wit...
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    Cybersecurity, Supply Chain Security, Good Distribution Practices and FDA’s Drug Registration Process

    Feature articles in December highlighted: cybersecurity regulations the benefits of serialization software EU GDP guideline five years later an overview of the current Israeli regulatory system conflicts with separate drug approval in adults and children components of FDA’s drug registration process how to perform a GMP audit the benefits of visual data Securing the Supply Chain Over the past decade, there has been an enormous explosion of minute networked m...
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    Biosimilars, Consumer Advertising and Medical Device and In Vitro Diagnostic Regulations

    November feature articles covered: An Update on Biosimilars Global IVD Regulation and Changing Clinical Evidence Requirements Consumer Advertising and Medical Device Regulations Regulatory Information Management Regulatory Science Biosimilars and Regulatory Science Over the last 10 years, biosimilar acceptance has progressed significantly in Europe and the US although several organizations are advocating for more complete, accurate, transparent prescribing and ...
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    Making Regulatory Information Management (RIM) Transformation Work

    This interview discusses taking a “process-centric approach” to Regulatory Information Management (RIM) and is based on presentations given by two regulatory professionals, Nancy Allen, a senior director in Global Regulatory Affairs at Eli Lilly and Paula Hudson, global implementation lead for RIM Systems Process at Eli Lilly. Allen and Hudson were presenters at the Veeva R&D Summit held on 19 September 2018 in Philadelphia, PA. RAPS: What were Eli Lilly’s goals in imp...
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    Advertising, Promotion and Labeling, Accelerated Approval and Regulatory Science

    October feature articles covered the following topics: the changing advertising and promotion landscape labeling accelerated approval regulations for drugs and devices comparability bridging studies for combination products FDA resources regulatory science In January 2017, the release of two guidance documents shook the pharmaceutical advertising and promotional landscape and, consequently, affected the “risk tolerance” level of regulatory professionals. In “ The...
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    Benefit-Risk Management, Global Advertising, Promotion and Labeling Regulations and Regulatory Intelligence

    Feature articles over the past weeks have focused on the ability to assess and manage the benefit-risk profile of drugs, rules for updating prescription drug labels, off-label communications efforts, FDA’s role in regulating the advertising and promotion of prescription drugs, biologics and medical devices, the challenges of regulating mobile applications versus computers systems and recommendations for measuring regulatory compliance of complementary medicines. Researchi...
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    Risk Management, Policy Framework, EU MDR and EU IVDR, and Global Orphan Drug Regulations

    Feature articles over the past weeks have focused on risk management, the global regulatory framework, including next generation cancer vaccines, drug delivery combinations and pediatric plans, the latest on EU MDR and EU IVDR implementation and global orphan drug regulations. Risk Management Recognized drug safety and risk management expert Elaine Morrato discusses the intersection of emerging implementation science and regulatory science innovation and how together...
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    Nutrition in Health and Disease Management

    Over time, regulatory frameworks have evolved to protect consumers and patients. An unprecedented progression of demographics—including an aging society, noncommunicable chronic diseases, and transforming innovations in healthcare—pose challenges and provide potential opportunities. Action is needed to develop timely, appropriate and affordable healthcare solutions for patients and society. Policies and regulatory frameworks must also be fit-for-purpose to stimulate innov...