Isis Valle R. Da Costa Email & Phone Number

Brasília, Federal District, Brazil

Regulatory and Scientific Intelligence in Dietary Supplements, Food and Beverages

Critical presentation of the Brazilian legal basis for inspection, auditing and supervision of the food industry, food services and mass events. Types of audits and principles of Hazard Analysis and Critical Control Points (HACCP). How to prepare for inspections of establishments and products regulated by the National Health Surveillance Agency (Anvisa), and by the Ministry of Agriculture and Livestock (Mapa). How to conduct internal audits and how to prepare to receive external audits. How to obtain voluntary certifications.

Brasília, Federal District, Brazil

Responsabilities:- Inbound sales: identifying and connecting with customers to provide tailored solutions.- Building strong relationships with customers to deliver great satisfaction with a problem-solving mentality applied to regulatory intelligence in health surveillance to attract and retain these customers, do business, increase market share, stay ahead of competition, and grow revenues and operations. - Solidification of the governance structure, standard operation procedures, processes flows and processes in the company’s Food, Beverage and Dietary Supplements department.- Leading a team of six people responsible for the strategic regulatory roadmaps of food, beverage, food supplements, food contact material products and ingredients to a wide range of national and international stakeholders to assure compliance with Brazilian regulations. - Managing of a portfolio of around thirteen accounts of continuous regulatory assistance subscribers, providing regulatory advice and information on substance, product and company levels, support for product development teams, advice on ingredients, formulations, and for label, product information and communication material compliance, and monitoring regulatory developments and trends.- Managing of around twenty simultaneous regulatory projects, leading and performing detailed reviews of regulatory risk assessments, safety and efficacy submissions, formulations evaluations, labeling statements, artworks and promotional material reviews, and regulatory opinions.

Brasília, Federal District, Brazil

Responsabilities:- Leading of a team of six people in the setting up of food, beverage, food supplements, food contact material products and ingredients strategic regulatory roadmaps to a wide range of national and international stakeholders to assure compliance with Brazilian regulations. - Implementation of a governance structure, standard operation procedures, processes flows and processes.- Managing of a portfolio of around ten accounts of continuous regulatory assistance subscribers, providing regulatory advice and information on substance, product and company levels, support for product development teams, advice on ingredients, formulations, and for label, product information and communication material compliance, and monitoring regulatory developments and trends.- Managing of around twenty simultaneous regulatory projects, leading and performing detailed reviews of regulatory risk assessments, safety and efficacy submissions, formulations evaluations, labeling statements, artworks and promotional material reviews, and regulatory opinions.Main Achievements: - Approval of four substances for the manufacture of compostable coffee capsules.- Approval of the claim “Lactobacillus rhamnosus GG (DSM 33156) may contribute to the health of the gastrointestinal tract” for a lower dose for dietary supplements.- First authorization to supplement the bioactive compound glucosamine with the approval of a glucosamine hydrochloride obtained from fermentation.- Approval of a maltogenic alfa-amylase enzyme from a genetically modified organism for use in bakery products.- First approval of a yeast trans-resveratrol in Brazil.

Brasília, Federal District, Brazil

Responsibilities:- Restructuration of the area, including the hiring and training of personnel and putting in place a governance structure, standard operation procedures and processes flows.- Technical and strategic support for inbound sales. - Managing of a team of eight people.- Managing of around twenty simultaneous projects, from understanding the clients and other stakeholders’ needs to coordinating the tasks of distributed remote project teams, detailed revision for quality control of all tasks and project progress monitoring.- Account management of around ten accounts of continuous regulatory assistance subscribers with revision of the orientations provided to address all requests from stakeholders (manufactures, distributors, importers, artwork agencies) on (new) food, beverage, dietary supplements and ingredients products development and regularization.- Coordination and moderation of meetings and calls with clients, other stakeholders, the team, and regulatory authorities to ensure appropriate communication takes place to complete all projects in an efficient manner.- Supervision and detailed revision of simplified systematic reviews of the scientific literature for efficacy assessment submissions requesting the approval of functional claims to the Brazilian Health Surveillance Agency (Agência Nacional de Vigilância Sanitária – ANVISA).- Leading the contributions to ANVISA public consultations.Main Achievements: - Inclusion of the update of the Brazilian norm for regenerate cellulose films intended to come into contact with food in ANVISA’s 2021-2023 regulatory agenda and in the MERCOSUL agenda.- First approval of a whole-food source of Vitamin D in Brazil with the inclusion of a vitamin D-enhanced mushroom in ANVISA’s IN 28/2018 positive list.- Establishment of standard regulatory procedures and projects and clients tracking tools.

Brasília, Federal District, Brazil

Responsibilities: - Project management in three different areas: 1) safety and efficacy assessment submissions to the Brazilian Health Surveillance Agency for the request of a wide-variety of new ingredients or food additives; 2) gap analysis of a wide-variety of new food supplements ingredients and functional claims’ compliance with Brazilian requirements; 3) food products and food supplements formulation regulatory analysis followed by the writing of the labeling statements and the labeling art revision for two different brands.- Account management: responsible for the regulatory demands (mostly food supplements formulation analysis, label statements and nutritional table writing, labelling art revision, and specific regulatory doubts) of a client from the sector of dietary supplements import.- Coordination of content creation (webinars, talks and social media) on Brazilian regulatory requirements for presentation to food, beverage, food supplements and ingredients stakeholders.Main Achievements:- First approval of algae-sourced beta-glucans for use in food supplements in Brazil with the inclusion of a whole cell algae and of isolated beta-glucans in ANVISA’s IN 28/2018 positive list.- First approval of a powdered omega-3 for use in food supplements in Brazil with the inclusion of an omega-3 fatty acid lysine complex in ANVISA’s IN 28/2018 positive list.- Reformulation of the company’s food area system to track regulatory submissions to the Brazilian Health Surveillance Agency.- Setting up of systems to analyze food products and food supplement formulations’ compliance to positive lists and limits of use.- Setting up of a system to automatically calculate nutrition facts tables.

Brasília Area, Brazil

Responsibilities: - Content creation (webinars, talks and social media) on Brazilian regulatory requirements for presentation to food, beverage, dietary supplements and ingredients stakeholders.- Project management in three different areas: 1) Safety and efficacy assessment submissions to the Brazilian Health Surveillance Agency for the request of a new ingredients or food additives for use in food supplements; 2) Gap analysis of new food supplements ingredients and functional claims’ compliance with Brazilian requirements; 3) Food products and food supplements formulation regulatory analysis followed by the writing of the labeling statements and the labeling art revision for two different brands.- Account management: responsible for the regulatory demands (mostly food supplements formulation analysis, label statements and nutritional table writing, labelling art revision, and specific regulatory doubts) of a client from the sector of dietary supplements import.- Constant monitoring, analysis, interpretation and implementation of applicable food law and other regulatory requirements such as international standards and norms.- Writing and/or review, compilation, submission and tracking of administrative, technical, and scientific documents for different regulatory procedures.Main Achievements: - First authorization to supplement the mineral boron in the form of food supplements in Brazil with the inclusion of sodium tetraborate decahydrate in ANVISA’s IN 28/2018 positive list.- Approval of anionic methacrylate copolymer for use in the coating of food supplements in Brazil as a glazing agent to provide moisture protection and to mask the taste of various nutrients present in the treated products.- A one-hundred-fold augmentation in the level of permitted use of sodium ascorbate in food supplements for children in Brazil to cover the amount needed for use as cryoprotectant in probiotics lyophilization.

Brasília Area, Brazil

Responsibilities: - Content creation (webinars, talks and social media) for presentation to food, beverage, dietary supplements and ingredients industry stakeholders on Brazilian regulatory requirements.- Project management assistance: support in the management of one large project for the safety and efficacy assessment submission of a new ingredient for use in food supplements to the Brazilian Health Surveillance Agency (Agência Nacional de Vigilância Sanitária – ANVISA).- Regulatory and scientific literature review to support food safety and efficacy assessment submissions.- Tracking of (new) food products regularization processes in the Brazilian Health Surveillance Agency.Main Achievements: - Webinars and talks to update to food, beverage, food supplements and ingredients industry stakeholders on the all-new Brazilian food supplements framework (a set of six norms published in July 2018).

Brasília Area, Brazil

Project manager of the production of a series of educational histology videos on exocrine glands for the Institute of Biological Sciences in Portuguese and English.- Benchmark of the histology educational videos available online.- Writing of the funding proposal for the Brazilian Research Support Foundation (Fundação de de Apoio à Pesquisa - FAPDF) covering the need for the project; detailed project plan, including, goals, objectives, detailed tasks, and timeline; and required equipment, consumables, personnel and budget.- Hiring and management of internal and outsourced personnel: undergraduate researcher, intern, illustrators, translators, announcer, sound engineer, video editors, etc.- Pre-production: study and selection of content, scripts writing, creation of storyboards, and supervision of histological slides light microscopy images production and of content translations.- Production: direction of the production of illustrations, recording of voiceovers, and editing and animation.

Brasília Area, Brazil

- Setup of the Histology Tutoring Program of the Institute of Biological Sciences for extra class assistance to Histology and related disciplines students, including governance setup, and team and schedule management. - Extra class and in class assistance to students.

Brasília Area, Brazil

- Production of e-learning food and nutrition courses focused on public health for health care professionals of the Brazilian Health Care System (Sistema Único de Saúde - SUS) in partnership with the Brazilian Department of Health and the Pan American Health Organization (PAHO/WHO).- Social media management for the Brazilian Health Care System Social Network - RedeNutri.

Brasília, Distrito Federal, Brazil

Responsibilities: - Regulatory and scientific literature review to support new food evaluation regulatory submissions to the Brazilian Health Surveillance Agency (Agência Nacional de Vigilância Sanitária – ANVISA).- Writing of newsletters for the food, beverage and ingredients industry stakeholders (manufactures, distributors, importers).- Tracking of [new] food product registration processes in the Brazilian Health Surveillance Agency.Main Achievements: - Setup of a tutorial for the tracking of new food product registration processes in the Brazilian Health Surveillance Agency.- Reformulation of the newsletter for the food, beverage, and ingredients industry stakeholders (manufactures, distributors, importers).

Paris, Île-De-France, France

Cash register operations, merchandising and counseling customers on organic and natural products.

Paris Area, France

- Technology watch and web analytics for key accounts such as Château de Versailles (www.chateauversailles.fr) and Tag Heuer (www.tagheuer.com).- Responsible for the global intranet and corporate news.

Paris, Île-De-France, France

- Inbound sales (rooms, transport, tours, tickets to local attractions). - Coordination of the daily activities of the hotel staff (housekeeping and maintenance).- General administrative and secretarial support.- Front office reception.- Sales of tours and tickets to local attractions.

Paris Area, France

- Commercial website innovation team assistant for http://edfentreprises.fr. - Benchmark of electricity companies' websites in Portuguese, Spanish, English and French.- Optimizations recommendations for http://edfentreprises.fr.

Brasília Area, Brazil

Promotion of politicians’ activities by press release writing, website update and press reception.

Brasília Area, Brazil

Police reporter.

Brasília Area, Brazil

Local rock themed TV show production.

Bachelor'S Degree, Journalism

Study and practice of the process of journalistic information creation in all kinds of media (print, radio, TV and internet): collection.

Bachelor'S Degree, Journalism

Study and practice of the process of journalistic information creation in all kinds of media (print, radio, TV and internet): collection.

Master 2, Creative Industries: Media, Web, And Arts

Transversal skills to create, produce, promote and enhance media, cultural, and artistic content by putting into perspective the different.

Master 1, Digital Communication: Project Management And Technology Watch

Digital communication strategies (digital medias, Internet, interactive products) and their conception, realization and finalization..

Licence, Communication, Informatique Et Multimédia

Basics of visual and audiovisual communication and its computing development.

International Exchange, Information And Communication

Basic and methodological theories in the Information and Communication science to analyze and create information and communication.

Bachelor Of Applied Science (B.A.Sc.), Nutrition Sciences

Activities and Societies: Histology tutoress.Skills to effectively assess, design and implement dietary strategies and nutritional.