MIRELLA ZAFFUTO Curriculum Vitae Contact Information ... - SSFA

MIRELLA ZAFFUTO
Curriculum Vitae
Contact Information
Address: Via Manzoni, 20- 29100 Piacenza-Italy
Telephone Number: +39.0523. 59.39.73
Mobile:+39. 349. 54.28.633
E-mail: mirella.zaffuto@zapharma.com; mirella.zaffuto@unife.it;
Education
Pavia Pavia University University, University Italy, Degree in Economics and Business, June 1988.
Università Università Università Cattolica Cattolica del del Sacro Sacro Cuore Cuore of of of Cremona Cremona, Cremona Italy (1989-90), MBA-SMEA,
Specialization and Master School in Economics of the Agricultural and Food System. SMEA
is member of ASFOR, the Italian Association for Management Education Development.
Università Università Università Cattolica Cattolica del del Sacro Sacro Cuore Cuore of of Piacenza Piacenza, Piacenza Italy (1995-98), Post-Graduate School of
Business Administration and Management.
Pavia Pavia Pavia University University, University School School School of of of Pharmacy Pharmacy, Pharmacy Italy (1999-2002), Post- Graduate Specialization in
Regulatory Disciplines , Thesis Title: “ Planning and Conducting Pharmacoeconomics
Analysis alongside a Randomized Clinical Trial”.
Employment
2002 2002-06, 2002 06, 2007 2007- 2007 present present Health Health Economist, Economist, Consultant
Consultant
Managing, conducting, preparing final reports, analyzing of published literature,
interpreting and collaborating on economic, decision analytic, epidemiological or
clinical-economic research as appropriate – prospectively (trials, registries) and
retrospectively (database, chart review, expert, panel Delphi, other available data)
including design of case report form, questionnaires, consent forms and other data
collection tools , combining best available data in clinical-economic models,
summarizing result and providing interpretation of findings;
Managing the strategic identification of need and opportunities for Health Economics
and Outcomes Research in order to demonstrate the drug value ( economic and
humanistic benefits) in support of the brand value proposition, in support of pricing and
reimbursement dossier for payer negotiations, and in support of the design of strategic
post-market studies across a broad therapeutic range, including Hiv/AIDS, Parkinson
Disease, Severe Chronic Pain, Radiotherapeutic Treatment, Myelodyspastic Syndrome,
Osteoporosis, for a wide variety of clients;
Designing and conducting studies to document the impact for in-line products and drug
in development (phase IIb/IIIa/IIIb) relative to standard treatment on resource
utilization, treatment costs, and productivity, applying appropriate methods,
Burden/Cost of Illness studies, Development Forecast and ROI Models included and in
support of BOA (Business Opportunity Assessment).
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2006 2006-07 2006 07 07 CRA/Health CRA/Health Economics Economics Local Local Project Project Coordinator Coordinator in in Charles Charles River River Laboratories
Laboratories
and and Kendle/Milan.
Kendle/Milan.
Performing investigator recruitment, pre trial, site initiation, interim monitoring, and
close-out visit in Phase II, Phase IIIA, Phase IIIB and Phase IV. In a variety of therapeutic
areas including but not limited to:
o HIV/AIDS
o Restless Legs Syndrome
o Chronic Idiopathic Thrombocytopenic
o Osteoporosis
Acting as the main line of communication between the sponsor and investigator.
Verifying that investigator has adequate qualifications and resources and remain
adequate throughout the trial period.
Verifying, for the investigational product(s).
Verifying that the investigator follows the approved protocol and all approved
amendment(s), if any.
Verifying that written Informed Consent was obtained before each subject’s
participation in the trial.
Ensuring that the investigator receives the current Investigator’s Brochure, all
documents, and all trial supplies needed to conduct the trial properly and to comply
with the applicable regulatory requirement(s).
Ensuring that the investigator and the investigator’s trial staff are adequately informed
about the trial.
Verifying that the investigator and the investigator’s trial staff are performing the
specified trial functions, in accordance with the protocol and any other written
agreement between the sponsor and the investigator/institution, and have not
delegated these functions to unauthorized individuals.
Verifying that the investigator is enrolling only eligible subjects.
Reporting the subject recruitment rate.
Verifying that source documents and other trial records are accurate, complete, kept
up-to-date and maintained.
Communicating deviations from the protocol, SOPs, GCP, and the applicable regulatory
requirements to the investigator and taking appropriate action designed to prevent
recurrence of the detected deviation.
Determining whether all adverse events (AEs) are appropriately reported within the
time periods required by GCP, the protocol, The Ethical Committees, the sponsor, and
the applicable regulatory requirement(s).
Checking the accurancy and completeness of the case report forms (CRF) entries,
source documents and other trial-related records against each other.
Informing the investigator of any CRF entry error, omission, or illegibility.
Taking part in Investigator Trials Meeting and Kick-off International Meeting
2001 2001-02 2001 02 Contract Contract CRA CRA Administrative/Clinical Administrative/Clinical Contract Contract Specialist Specialist in in Parexel/Milan
Parexel/Milan
Responsible for Legal, Regulatory ,Economic contractual issues and negotiations with
the legal/administrative departments of Hospitals and Universities in order to finalize
Clinical Trial Agreement between sponsors and clinical research local sites.
As the clinical contract specialist liaising with other departments, primarily Clinical and
Regulatory Services and Project Management, on requirements for confidentially and
clinical study agreement, reviewed site contract template to ensure legal compliance
consistent practices, completeness and accuracy. Developing local Parexel template
and adapting statements of agreement templates, as necessary. Negotiating and
monitoring compliance with, new and amended contracts.
1989 1989-2000
1989 1989 2000 2000 Economist Economist , , , Free Free -lance lance
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