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Summary

Lifesciences professional with 13 years experience working for the top-leading Pharmaceutical, Medical Device, Biotechnology, chemical and cosmetic-dermatological industry. i have studied MSc Bio-engineering at ulht (pt), massachusetts institute of technology (mit, boston, usa), healtheconomics in oxford University (uk), mba at ie business school (spain), phd program at medicine faculty (first year in neurosciences) – universidad autonoma de madrid/instituto ramon y cajal (spain). currently i am studying medicine at ulb (belgium). i speak French (b2/c1), dutch (b2/c1), English (b2/c1), portuguese (c2), spanish (c2), and intermediate italian. have been an invited Teacher at hibernia college and have participated as a speaker in several conferences. i have 4 years experience in bioprocess engineering and 12 years experience in Market access, Strategy, heor, competitve intelligence, and Regulatory Affairs Consultant in different Therapeutic Areas (oncology, Cardiology, Vaccines, Diabetes, Ophthalmology, CNS, Dermatology, Immunology, biosimilars, Biomarkers and Personalized Medicine and rare diseases) serving international clients at global level – emea (belgium, germany, uk, portugal, spain, etc …), latam (brazil, etc), usa and asia. i have worked for several companies such as biotrend and ims Consulting Publications, awards and conference contributors: - kerr, c. calé, j. m. s. cabral and f. van keulen, “factors enhancing lycopene production by a new mycobacterium aurum mutant strain bio-02”, Biotechnology letters scientific magazine (2004). - iapmei national award of Innovation of the best young business woman in 2006, portugal - main invited speaker at “xxxvi congress of gynaecology and obstetrics in guatemala“ - “Genomics and Proteomics new application in the biotech business” 2008 - invited speaker at the “nutrigenetics and nutrigenomics” conference, greece, 2007 extra activities: voluntary work in geriatrics and blood donor

Experiences

Current Experience

  • Engineering, Project Management


    Since October 2015
    trusted Partner at q-people, our background is in projects. we started with Training, mentoring and Coaching of engineers. since then we have grown into a mature company that provides quality services (to our employees and to our clients). our team is made up entirely of specialists, experts who achieve solid results in their field. you can count on that! smart view on project staff as an Employee you have a professional profile. we strengthen these personal, emotional sociable and intellectual skills. this will show in your professionalism. quality first and foremost our project staff deliver outstanding experience. they are professionals that you can rely on. this makes them the best workers you could want for your company. because they grow together with you, prosper and deliver optimal performance. you can count on that. we take care of that! TRUSTED PARTNER At Q-People, our background is in projects. We started with training, mentoring and coaching of engineers. Since then we have grown into a mature company that provides quality services (to our employees and to our clients). Our team is made up entirely of specialists, experts who achieve solid results in their field. You can count on that! SMART VIEW ON PROJECT STAFF As an employee you have a professional profile. We strengthen these personal, emotional sociable and intellectual skills. This will show in your professionalism. QUALITY FIRST AND FOREMOST Our project staff deliver outstanding experience. They are professionals that you can rely on. This makes them the best workers you could want for your company. Because they grow together with you, prosper and deliver optimal performance. You can count on that. We take care of that!

  • Owner, Division Market Access, HealthEconomics and Regulatory Affairs


    Since October 2012
    biodatapharma supports companies in the Pharmaceutical, Biotechnology, Bioengineering, Bioprocessing, Biomedical and Medical Devices sector in the creation and development of new solutions for the success of their business.  biodatapharma offers Market access, healtheconomics and Regulatory Affairs services. hereunder follows some of the competences: Project Management o Market access Strategy and launch strategies o Reimbursement dossiers (decision problem Analysis, Clinical effectiveness Analysis, costeffectiveness Analysis, budget impact Analysis, markov modelling) o identify key opinion leaders (kols), Market access advisors and influencers and their organizational relationships in key stakeholder groups (payer, patient and Physician) o development, management, and execution of strategies and tactical plans to influence Policy issues affecting patient access, provider adoption, and Reimbursement for current and future products, including Health Economics analyses, key influencer relationship management (Physician, government, payer, etc.), public affairs tools, legislative strategies, and highlytuned communications work. o portfolio management and evaluation early Market access Phase II, iii Phase IV and post-Marketing approvals medical writting and scientific translations o ensure the appropriate Licensing, Marketing and legal Compliance of Pharmaceutical and medical products in order to control the safety and efficacy of product o literature review, Clinical pathway Validation, interviewing kols, writing and publishing papers o conduct secondary and primary Research interviews and questionnaire development for a variety of respondent types website: www.biodatapharma.com facebook: https://www.facebook.com/pages/biodatapharma/411614399033509?ref=hl BioDataPharma supports companies in the Pharmaceutical, Biotechnology, BioEngineering, BioProcessing, Biomedical and Medical devices sector in the creation and development of new solutions for the success of their business.  BioDataPharma offers Market Access, HealthEconomics and Regulatory Affairs services. Hereunder follows some of the competences: Project Management o Market access Strategy and Launch strategies o Reimbursement dossiers (Decision Problem Analysis, Clinical Effectiveness Analysis, CostEffectiveness Analysis, Budget Impact Analysis, Markov Modelling) o Identify key opinion leaders (KOLs), Market Access Advisors and Influencers and their organizational relationships in key stakeholder groups (payer, patient and physician) o Development, management, and execution of strategies and tactical plans to influence policy issues affecting patient access, provider adoption, and reimbursement for current and future products, including health economics analyses, key influencer relationship management (physician, government, payer, etc.), public affairs tools, legislative strategies, and highlytuned communications work. o Portfolio Management and Evaluation Early market access Phase II, III Phase IV and post-marketing approvals Medical writting and scientific translations o Ensure the appropriate licensing, marketing and legal compliance of pharmaceutical and medical products in order to control the safety and efficacy of product o Literature review, clinical pathway validation, interviewing KOLs, writing and publishing papers o Conduct Secondary and Primary Research interviews and questionnaire development for a variety of respondent types website: www.biodatapharma.com facebook: https://www.facebook.com/pages/Biodatapharma/411614399033509?ref=hl

  • Owner BioDataPharma (Division Pharma/Biotech Engineering) workig for Q-People


    Since September 2012
    Validation, technology engineering, scale-up, dimensioning, cleaning, Project Management solve technical problems Project Management technical and analytical knowledge in this area design and development of simple and low cost solutions to daily basis Process Engineering Lab case analysis, create and implement standards and best practice experience (gmps). develop new methodologies and implement new technologies; write technical reports and Research papers; biocatalysis reactors design economic and Market Analysis, Manufacturing selection processes and equipment dimensioning, facility layouts R&D Project Management website: www.biodatapharma.com facebook: https://www.facebook.com/pages/biodatapharma/411614399033509?ref=hl Validation, Technology engineering, Scale-up, dimensioning, Cleaning, Project Management Solve technical problems Project Management technical and analytical knowledge in this area design and development of simple and low cost solutions to daily basis process engineering Lab case analysis, create and implement standards and best practice experience (GMPs). Develop new methodologies and implement new technologies; Write technical reports and research papers; BioCatalysis Reactors design Economic and Market Analysis, Manufacturing selection processes and Equipment dimensioning, Facility Layouts R&D Project Management website: www.biodatapharma.com facebook: https://www.facebook.com/pages/Biodatapharma/411614399033509?ref=hl

  • Owner


    Since October 2003
    stress and burnout Coaching nutritional Consulting image Consulting workshops webpage: www.catiacalecoaching.com facebook: https://www.facebook.com/catiacalecoaching linkedin: https://be.linkedin.com/pub/catia-andreia-cale/105/154/295 Stress and Burnout Coaching Nutritional Consulting Image Consulting Workshops webpage: www.catiacalecoaching.com facebook: https://www.facebook.com/catiacalecoaching linkedin: https://be.linkedin.com/pub/catia-andreia-cale/105/154/295

Past Experience

Knowledge

LinkedIn Assessment :
BiotechnologyPharmaceutical IndustryLifesciencesoncologyImmunologyMarket accessDrug DevelopmentMedical DevicesClinical trialsClinical DevelopmentRegulatory affairsCardiologyDiabetesDermatologyNeurologyRegulatory Affairs; Healtheconomics;Market Access; Portfolio Management; Strategy

Education

  • Doctor of Medicine (MD) in Medicine from Université libre de Bruxelles in 2017
  • Health Economics in from University of Oxford in 2014
  • in Business Engineering from Massachusetts Institute of Technology in 2012
  • Certificate in Stress and Burn-out Management and Coaching in from University of Central Florida in 2009
  • Master of Business Administration (MBA) in MBA from IE Business School in 2009
  • Doctor of Philosophy (PhD) (1st year) in Neurobiology and Neurosciences from Universidad Autónoma de Madrid in 2005
  • Biotechnological Engineering, Project Engineering in Engineering from Universidade Lusófona de Humanidades e Tecnologias in 2003

Training and Certification

  • Image consulting in 0000 Certification
  • Medical Nutrition in 0000 Certification
  • New Jersey Institute of Technology in 0000 Certification
  • Pharmaceutical Validation Processes in 0000 Certification
  • Process Validation for Medical Devices in 0000 Certification
  • Stress and Burnout Management in 0000 Certification

Area / Region

Vilvoorde, Belgium

Others

Driving License
  • No

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