Tiina Alvre, BSc (Hons), PhD
Tiina Alvre is eCTD Office's exclusive distributor / partner / consultant in Australia / New Zealand.
eCTD Office is an off-the-shelf suite of integrated eCTD / NeeS / VNeeS software products for the creation, validation, publishing, viewing and manipulation of regulatory documentation for electronic submissions by pharmaceutical companies to regulatory authorities. Various tools included in the package ensure your work continues flawlessly.
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Partner in Australia
Tiina Alvre's Expertise
A graduate of the University of Sydney, Tiina Alvre has an academic background in molecular genetics and neurobiology research.
Regulatory expertise and ongoing consultative work encompasses TGA and Medsafe prescription, OTC and devices registration and variations submissions for multinational pharmaceutical companies in a broad range of therapeutic areas.
A long-standing interest in software solutions for document and data management underlies recent and ongoing consultative involvement with software engineers in the development and implementation of document management and electronic submissions publishing solutions.
Professional Experience
- Consultant for development and implementation of eCTD Office software to TGA eCTD and NeeS requirements
- Consultant for redesign and upgrade of electronic document management system, documentum, for management of regulatory documents
- Regulatory Department management
- Regulatory submissions to TGA and Medsafe (Prescription, OTC, devices), Import Permit and Licence applications and renewals
- Pharmaceutical company representative on Working Groups: Medicines Australia, Australian Self-Medication Industry (ASMI), Medicines New Zealand
- Head of Neurobiology medical research laboratory
- Academic lecturing, Honours and PhD student supervision and PhD thesis examination, author of original research papers, invited reviews and an invited monograph