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This comprehensive resource covers product change evaluation, postmarket surveillance, audit/inspection compliance, and various other laws and regulations pertaining to maintaining a product on the market.
Hear from leaders around the globe as they share insights about their experiences and lessons learned throughout their certification journey.
This is a recording from August 2022
RAPS first of its kind e-book, Nutrition, Health, and Disease: Regulatory Policy Matters, is a practical source depicting the importance of nutrition and the gut microbiome in noncommunicable chronic diseases (NCD) prevention and management bringing together the regulatory facts and policy considerations by a consortium of global subject matter experts. Readers will be able to use the information gathered in this e-book to gain the knowledge of multiple rapidly evolving areas, including the gut microbiome, to develop timely, appropriate, and affordable healthcare solutions for patients and society. Through real-world examples and case studies, this e-book offers practical advice to help readers navigate the current, often complex, regulatory environment. The vital hands-on practical information paired with the strategic discussion will demonstrate the importance of food and nutrition strategies in key regions.
Filling a gap in RAPS' portfolio: Nutrition, Health and Disease: Regulatory Policy Matters is the first ever electronic nutrition book by RAPS. It is preceded by and partially based on a series of RAPS Regulatory Focus nutrition innovation articles as well as respective RAPS Annual Convergence workshops and presentations over the last decade.
All regulatory affairs professionals with an interest in global pharma and food regulations.
Nutrition, Health, and Disease: Regulatory Policy Matters was developed for regulatory professionals of all levels of RAPS Regulatory Competency Framework, including newcomers and seasoned professionals as well as academics and governmental employees. Regulatory professionals at Levels 1 and 2 of the framework will be able to easily access relevant nutrition regulations and guidance in specific countries and how to apply them in one convenient place. For more senior professionals at Levels 3 and 4 responsible for global regulatory strategy, the book will serve as a valuable resource to facilitate strategic discussions on nutrition regulations and policy worldwide.
Manfred Ruthsatz, PhD, RPh, DABT, RAC, FRAPSExecutive DirectorNutrition+HealthCARE, Switzerland
Manfred Ruthsatz, PhD, RPh, DABT, RAC, FRAPS, is the executive director of Nutrition+HealthCARE, Switzerland, which focuses on specialized and personalized nutrition, the gut microbiome, and healthy longevity. His healthcare regulatory experience, rounded out by quality, safety, vigilance, health economics, and reimbursement, spans more than 30 years in diverse healthcare industry and public health service settings, including US FDA’s CDER and NIH. His publishing and speaking activities in Europe, US, Asia, and LATAM include a wide array of regulatory- and policy-related healthcare topics, with a focus on the health and disease continuum and global convergence. He is an active member of RAPS and its Editorial Advisory Committee, as well as multiple other regulatory, scientific, and nutritional institutions and advisory boards.
Andrea W. Wong, PhDSenior Vice PresidentScientific and Regulatory Affairs
Council for Responsible Nutrition
Andrea W. Wong, PhD, is senior vice president, scientific and regulatory affairs, at the Council for Responsible Nutrition. She leads CRN’s science and regulatory affairs department, responding to emerging scientific and regulatory issues as well as advocating for science-based nutrition. Wong also provides scientific expertise in evaluating research relevant to the benefits and safety of ingredients and dietary supplements, and in support of CRN’s nutrition policy activities. She leads proactive, self-regulatory initiatives, including the development of best practices guidelines for industry on product labeling and formulation.
Gloria HallSenior EditorRAPS
Gloria Hall, RAPS senior editor of publications has more than 20 years of experience managing, marketing, and publishing internationally-recognized publications, including a bimonthly magazine, a quarterly scientific journal, technical guides, and newsletters.
Excellent qualifications in strategic planning and analysis with comprehensive knowledge of project management and execution, publication development, product development and marketing, brand management, and team building
Skilled at establishing and managing strategic partners to develop new products and penetrate new markets.
Proven ability to cultivate productive relationships with key decision makers and manage projects on a global basis.
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