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  • Feature ArticlesFeature Articles

    The Changing Role of Regulatory Professionals

    Regulatory Focus has brought together a diverse group of experts to address today’s most pressing issues for regulatory professionals on communication methods to employ with various stakeholders regarding why regulatory is important. Global experts provided insight and shared their experiences on the importance of regulatory affairs to key company decision makers, including what regulatory can do for all stakeholders, demonstrating regulatory value and writing informed c...
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    Changing Regulatory Landscape, Strategy and Global Policy

    January feature articles explored the vital role of regulatory within organizations and throughout the product lifecycle. Some of the leading experts in the profession have come together to share their valuable experience on a wide range of issues impacting regulatory professionals today, including regulatory leadership for a culture of quality, how to successfully hire and engage consultants, regulatory’s role in business strategies and UDI and recall management. Other ar...
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    Advertising, Promotion, Labeling and the Role of Social Media in Regulatory Communications

    Articles throughout December explored advertising, promotion and labeling in addition to the role of social media in regulatory communications. Leading experts in the profession shared valuable insight on a wide range of issues impacting APL professionals today, including optimizing ad/promo regulatory affairs communications, Facebook chat study results and the use of hashtags, social media influencers and considerations, price transparency and assessing risk and strategic...
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    Regulatory Intelligence and Policy

    To support the release of the Q4 Regulatory Focus Article Series, Regulatory Intelligence and Policy: Shaping the Global Landscape , RAPS hosted a lively discussion on Regulatory Exchange with three regulatory intelligence experts, Meredith Brown-Tuttle, Matt Medlin and Kirsten Messmer. The experts , who were all authors in the series, offered their perspectives on the importance of regulatory intelligence and the integral role RI professionals play in defining strate...
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    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...