Profile Details

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Hire Dr. Vera M.

United States

USD 200 /hr

Clinical Research - Drug & Medical Device development and regulatory compliance (GCP/GLP/ISO 13485) - Expert Consultant

Profile Summary

Providing leadership and strategic direction in Drug/Medical Device Development and Quality assurance to meet the new Industry challenges Leadership in new business development (drug, medical device and medical software development quality management, pharmaceuticals, diagnostic systems). Strong multidisciplinary clinical, regulatory and quality strategies to enhance business operations. GCP/GLP and ISO 13485 Audit and support. Established and overseen a successful and complete medical device company overhaul during covid-19. Also, ISO 27001 ISMS internal auditor. Overseen and implemented clinical research departments and quality management processes and SOPs. Established and overseen complete clinical research and quality programme in preparation for successful acquisition by large medical device company. Overseen and implemented, including complete review, of clinical research and quality program Re-structured and implemented complete quality system design and regulatory compliance (FDA/EMA/HC) for spin off biotech and medical device company Lead the transition from experimental and preclinical phase of development of a new therapeutic product for pharmaceutical company to clinical development and pharmacovigilance. Expert consultant for the European Commission.

Subject Matter Expertise

• ☆ Evolutionary Biology
• ☆ Biostatistics
• ☆ Biochemistry
• ☆ Immunoassay
• ☆ Biochemical Assays
• ☆ Structural Biology
• ☆ Enzyme Activity Assays
• ☆ Molecular Biology
• ☆ Biomarkers
• ☆ Genetics
• ☆ Omics
• ☆ Proteomics
• ☆ Metabolomics
• ☆ Protein Sequencing
• ☆ Drug Development
• ☆ Vaccine Development
• ☆ Medical Devices
• ☆ Post-Market Surveillance
• ☆ Medical Device Development
• ☆ Medical Device Validation
• ☆ Medical Device Regulatory Consulting
• ☆ European Medical Device Regulation (MDR)
• ☆ ISO 13485
• ☆ ISO 14971
• ☆ Clinical Trials
• ☆ IRB Applications
• ☆ Clinical Trial Design
• ☆ Patient Recruitment
• ☆ Clinical Data Management
• ☆ Clinical Trial Site Selection & Monitoring
• ☆ Clinical Trials Data Analysis
• ☆ Pharmacovigilance/Drug Safety Monitoring
• ☆ Preventive Medicine
• ☆ Infectious Disease
• ☆ Viral Diseases
• ☆ COVID-19
• ☆ Risk Management

Services

• Writing
• Research
• Consulting
• Data & AI

Writing Clinical Trial Documentation, Medical Writing, Non-Medical Regulatory Writing, Technical Writing, Business & Legal Writing, Copywriting, Creative Writing, Newswriting, General Proofreading & Editing, Translation

Research Feasibility Study, Fact Checking, Gap Analysis, Scientific and Technical Research, Systematic Literature Review

Consulting Legal Consulting, Operations Consulting, Scientific and Technical Consulting, Regulatory Consulting

Data & AI Data Cleaning, Data Insights

Work Experience

Expert consultant

European Commission

January 2015 - Present

Executive Director

Global Research Pharma Canada/EduPharma Canada

January 2000 - Present

Head of Clinical Research Program

AAPS Inc.

January 2003 - January 2013

Senior Scientist / Group Manager

Novartis pharmaceuticals

January 1998 - January 2000

Prinicipal and Senior Consultant

Professional Consultant

January 1996 - January 1998

Clinical Project Manager

Ciba Geigy Canada

January 1992 - January 1995

Post doc research fellow- Teaching Assistant

Banting and Best institute for Medical Research - University of Toronto

January 1989 - January 1992

PhD Research Fellow - Teaching Assistant

University of Buenos Aires

January 1985 - January 1989

Education

Post-Doc

University of Toronto

January 1989 - January 1990

PhD

University of Buenos Aires

January 1985 - December 1989

M.Sc (Master of Science)

University CAECE

December 1982 - December 1984

Bachelor of Science

University CAECE

January 1980 - December 1982

Certifications

• Certification details not provided.

Publications

BOOK

https://www.wiley.com/en-us/Clinical+Trials+Audit+Preparation%3A+A+Guide+for+Good+Clinical+Practice+%28GCP%29+Inspections-p-9780470920886 .

JOURNAL ARTICLE

Mihajlovic V, Cascone O, Biscoglio de Jiménez Bonino MJ (1993). Oxidation of methionine residues in equine growth hormone by Chloramine-T . The International journal of biochemistry.

Mihajlovic V, Krolczyk AJ, Auerbach W, Buchwald M, Schimmer BP (1992). Expression of a mutant regulatory subunit of cAMP-dependent protein kinase in the Caco-2 human colonic carcinoma cell line . Biochemistry and cell biology = Biochimie et biologie cellulaire.

Cascone O, Fukushima JG, Mihajlovich V, Santomé JA, Biscoglio de Jiménez Bonino M (1992). An equine growth hormone molecular species lacking the 76-92 peptidic fragment . International journal of peptide and protein research.

Mazza MM, Gobet MG, Biscoglio MJ, Mihajlovich V, Guillemot JC, Vita N, Ferrara P, Retegui LA (1990). Relationship between the antigenic topography and the structure of human growth hormone . Endocrinology.