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    RAPS Welcomes Utah Chapter

    Just over a year after a RAPS-affiliated local networking group was successfully established in Utah, the group officially became the RAPS Utah Chapter. Chapter Chair Robert Wolfarth, senior manager of regulatory affairs for Merit Medical Systems Inc., shared the news and gave a brief overview of the chapter’s vision and mission on 1 November at the Utah Life Sciences Summit in Salt Lake City, an annual industry event organized by BioUtah, a statewide association of lif...
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    Looking Back at the 2018 Regulatory Convergence: the Newsworthy and Noteworthy

    Attendees of RAPS’ 2018 Regulatory Convergence in Vancouver, 1–4 October, were among the first to learn about important developments and the latest news on topics including the coming EU Medical Device Regulation (MDR), the US Food and Drug Administration’s (FDA) cybersecurity policies and the results of RAPS’ comprehensive global salary survey of regulatory professionals. The event also marked the first time RAPS’ annual gathering has been held in Canada. The confer...
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    RAPS Introduces Pharmaceutical- and Medical Device-Focused Regulatory Affairs Certifications (RACs)

    RAPS today announced two new Regulatory Affairs Certifications (RACs) will become available beginning with the next RAC exam period in spring 2019. Exam applications are now being accepted. The two new exams and associated credentials are called the RAC (Drugs) and RAC (Devices). They join the four previously established, regional exams: US, EU, Canada and Global. The RAC is the only post-academic professional credential for the healthcare product regulatory field....
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    RAPS Releases Results of Compensation Survey of Regulatory Professionals

    RAPS today released the results of its comprehensive global survey of healthcare product regulatory professionals, offering a detailed look at how much they earn, which products they work on, what their work entails, and how their roles within their organizations have evolved. RAPS’ 2018 Global Compensation & Scope of Practice Report for the Regulatory Profession aggregates salary data for more than 2,300 respondents from 64 countries and breaks down median and averag...
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    John Lim, Justina Molzon, Barbara Schneeman and Mike Ward to Receive RAPS’ Highest Honor

    RAPS has announced the recipients of its 2018 Founder’s Award. They are: John Lim, MD, executive director, Center of Regulatory Excellence, Singapore; Justina Molzon, JD, former associate center director for international programs, Center for Drug Evaluation and Research (CDER), US Food and Drug Administration (FDA); Barbara Schneeman, PhD, former director, Office of Nutrition, Labeling and Dietary Supplements, FDA; and Mike Ward, coordinator, Regulatory System Strengthen...
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    RAPS to Honor Lena Cordie, Alan McEmber for Outstanding Community Leadership

    RAPS has announced the recipients of its 2018 Community Leadership Award. They are: Lena Cordie, president, Qualitas Professional Services, and Alan McEmber, MS, RAC, head, therapeutic area regulatory strategy, Shire. The Community Leadership Award recognizes RAPS members who have helped build thriving local networks, supported fellow regulatory professionals and acted as RAPS ambassadors. Cordie and McEmber will be honored and receive their awards next week during RAP...
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    Focus on: Susumu Nozawa

    Susumu Nozawa, RAC (US and EU), FRAPS, is the current chair of RAPS’ board of directors. He has more than 15 years of experience in US and international regulatory affairs and compliance, most recently as director of technical and regulatory policy and corporate regulatory affairs at BD in Franklin Lakes, NJ. He also is an active volunteer leader with RAPS as well as other professional organizations, including AdvaMed and the American Medical Devices and Diagnostics Manuf...
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    Daniel Mannix, Sandra Matsumoto and Frank Pokrop Named RAPS Fellows

    RAPS today announced the names of its 2018 class of RAPS Fellows. Daniel Mannix, PhD, FRAPS, vice president, regulatory affairs, MacroGenics Inc.; Sandra Matsumoto, PhD, RAC, FRAPS, vice president, regulatory affairs, Sebela Pharmaceuticals; and Frank Pokrop, CPGP, CQA, CQE, CSQE, RAC, FRAPS, senior director, regulatory affairs and quality assurance, Sotera Wireless, are the latest to join this elite group of accomplished regulatory professionals, the RAPS Fellows . Th...
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    Medical Device Validation: What You Need to Know and Why It's Important

    Inadequate process validation is one of the most common issues leading to warnings from the US Food and Drug Administration (FDA). It may also be the most difficult to address, according to Max Sherman, the editor of RAPS’ recently published second edition of The Medical Device Validation Handbook . Unfortunately, many regulatory and quality professionals, and others involved in device compliance, lack the necessary knowledge and expertise. “People need a greater unders...
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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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    Top Latin American Officials to Examine Region’s Regulatory Challenges and Opportunities at RAPS Regulatory Convergence

    RAPS’ upcoming 2018 Regulatory Convergence , to be held 1–4 October in Vancouver, will once again serve as the venue for a high-level discussion of the regulatory challenges and opportunities for introducing innovative medical treatments throughout Latin America. Some of the region’s top regulators, such as Rafael Pérez Cristiá, MD, PhD, director of the Center for State Control of Drugs and Medical Devices (CECMED), part of Cuba’s Ministry of Public Health; and Julio Sán...
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    How to Prepare for the RAC Exam

    Earning your Regulatory Affairs Certification (RAC) is a significant investment in your regulatory career. The RAC is the only professional credential specifically for regulatory professionals in the healthcare product sector. It shows employers, clients, colleagues and others not only that you have the requisite regulatory knowledge, but also that you are committed to your profession. To get the credential, you must pass one of four challenging RAC exams—the average pa...