• Feature ArticlesFeature Articles

    The Transformation of Digital Health: What it Means for Regulatory Professionals

    Articles throughout November focused on what the changing digital health landscape, including big data, means for regulatory professionals. Leaders in the digital health space shared their insight and best practices on the challenges and opportunities of implementing digital health solutions, data safety and data risk in the digital healthcare sector and global digital drug information sources. Authors presented the impact of Software as a Medical Device (SaMD) on commerci...
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    Evolving Global Regulatory Landscape, Strategies and Best Practices

    October feature articles reported on a number of timely issues facing regulatory professionals today, including the advantages of using periodic safety update reports, practical solutions to pharmaceutical labeling challenges and best practices and strategies to manage global projects. Experts discussed a process to reform the medicinal products authorization system in China, illustrated the the need for regulatory requirements for ‘herbasimilars’ and introduced readers ...
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    Regulatory Strategies for EU MDR and EU IVDR Implementation

    September feature articles took an in-depth look at the new EU Medical Devices Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR), where global medical device leaders explored the nuances of the new requirements and answered the industry’s most challenging questions. Individual articles covered the implementation of the regulations into national legislation, what the new regulations mean for substance-based medical devices, how to incorporate clinical evaluation re...
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    Changing Role of Regulatory Professionals, Career Development and Global Regulations

    Feature articles in August covered the changing role of regulatory professionals including critical thinking and leadership skills, professional development strategies, the importance of obtaining professional qualifications and techniques for transitioning roles in a contract research organization. Other articles covered eCTD submission management, FDA’s TRG Rapid Inquiry Program, an overview of administrative law and considerations for implementation of a companion diagn...
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    Changing Global Regulatory Landscape and Strategy for Drug and Device Operations

    Feature articles in July explored regulatory operations for drugs and devices. Topics included FDA and EU differences in cleanroom specifications, EU accelerated pathway programs, and data requirements for biosimilars versus the reference medicine. Other articles covered India’s new drug and clinical trial rules, China’s new guidance on regulatory inspection and analytical testing documentation, and medical device cybersecurity.   Regulatory Operations for Drugs and Dev...
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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 also must be fit-for-purpose to stimulate innovat...
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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...