Gitte Frausing Email and Phone Number
Gitte Frausing work email
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Gitte Frausing personal email
Data standards expert in CDISC SDTM and SEND. Since 2007 I have been an active part of the CDISC (Clinical Data Interchange Standards Consortium) working closely with other members of the pharmaceutical industry, contract research organisations and the FDA (Food and Drug Administration, US) in the development of a standard for electronic non-clinical data (SEND – Standard for Exchange of Non-clinical Data). Implementation experience with data standards include project management, defining and leading nonclinical data standardization effort, process analysis and future workflow description, user requirement specification & software selection and deployment.Specialties: CDISC SEND, Data standards - electronic data, Nonclinical data and terminology, IT system specification and selection, regulatory requirements for drug submissions, FDA requirements for nonclinical electronic data.
Data Standards Decisions Aps
View- Website:
- datastandardsdecisions.com
- Employees:
- 5
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Principal Compliance Consultant For Electronic Study Data SubmissionData Standards Decisions Aps Sep 2014 - PresentDenmarkIndustry consultant for end-to-end business strategies, processes and implementation of solutions for electronic standardized data from small laboratories to large pharma companies.Data conversion and submission compliance support.Specialist in:- CDISC SEND compliance- eSubmisison requirements- Process design and improvement in nonclinical data life cycle- Software selection and deployment- Data conversion and terminology mapping (SDTM & SEND)- Training (authorized CDISC instructor; see www.cdisc.org)
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Senior Scientist In It And Quality Systems ManagementNovo Nordisk A/S Dec 2012 - Sep 2014DenmarkResponsible for data management, including the technical coordination of data capture from nonclinical studies within development projects at Novo Nordisk.- Defining IT architecture and strategy- IT solution description and URS- System testing- Defining data dicitonaries and mapping- Process and workflow descriptionsLeader of Nonclinical Standardization.- Data standards expert (interpretation and education)- Defining internal data standards- Data standards governance -
Research Scientist With Project Management ResponsibilityNovo Nordisk A/S Apr 2012 - Dec 2012Copenhagen Area, Denmark• Accountable for non-clinical IT project execution.• Responsible for ensuring that NN receives a solution that delivers the benefits described in the project agreement.• Responsible for ensuring project adoption and business transformation for NN including identification of training needs and associated planning.
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Regulatory ProfessionalNovo Nordisk A/S Aug 2011 - Apr 2012Copenhagen Area, DenmarkRegulatory Affairs - Development projects, Hemophilia- External communications task-force for pegylated products- Planning and preparation of submissions activities to national health agencies, EMA and FDA;- Review of CTA/IND dossier; non-clinical and clinical documentation incl. Investigational Medicinal Product Dossier, Investigators Brochure and module 4 reports.- CTA/IND submissions globally- Coordination and compiling responses to national health agencies, EMA and FDAOther- Submission of clinical bioequivalence data in Canada- PIP applications (EU)- Orphan drug applications - Scientific Advice briefing packages (EMA and FDA)- Planning and coordinating project tasks- Optimisation of internal processes
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Research Scientist In Toxicology And Safety PharmacologyNovo Nordisk A/S Dec 2006 - Aug 2011Copenhagen Area, DenmarkMain job function: Project toxicologist* Responsible coordinator for all aspects of toxicology* Working with central laboratories in the conduct on nonclinical studies* Preparation of documentation according to eSubmission standards recommended by the FDA, including eCTD requirements, CDISC standards and the Study Data Specification guidance.Specific competencies: * Carrier mediated delivery of biologics* Safety assessment of excipients and inactive ingredients* Carcinogenicity dataset* Knowledge of electronic submissions, incl. eCTD and CDISC SEND.
Gitte Frausing Skills
Gitte Frausing Education Details
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Applied Toxicology -
Biology
Frequently Asked Questions about Gitte Frausing
What company does Gitte Frausing work for?
Gitte Frausing works for Data Standards Decisions Aps
What is Gitte Frausing's role at the current company?
Gitte Frausing's current role is Principal Consultant at Data Standards Decisions Aps.
What is Gitte Frausing's email address?
Gitte Frausing's email address is gt****@****isk.com
What schools did Gitte Frausing attend?
Gitte Frausing attended University Of Surrey, University Of Copenhagen.
What are some of Gitte Frausing's interests?
Gitte Frausing has interest in Science And Technology.
What skills is Gitte Frausing known for?
Gitte Frausing has skills like Fda, Pharmaceutical Industry, Toxicology, Cdisc, Drug Development, Data Standards, Regulatory Submissions, Cro, Life Sciences, Drug Discovery, Glp, U.s. Food And Drug Administration.
Who are Gitte Frausing's colleagues?
Gitte Frausing's colleagues are Henrik Söeborg.
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