Maestro Alessandra

CURRICULUM VITAE
PERSONAL INFORMATION
Name
Address
Telephone
Fax
E-mail
Nationality
Date of birth
ALESSANDRA MAESTRO
VIA BONAPARTE 2/1, 34123, TRIESTE
+39 349 3434014
040/3785411
[email protected], [email protected]
Italian
30th April 1979
EXPERTISE
•
Principal areas of expertise
Pharmacy, Clinical Pharmacology, Clinical Trials
WORK EXPERIENCE
• Dates (from – to)
• Name and address of employer
• Type of business or sector
• Occupation or position held
Page 1 - Curriculum vitae of
Maestro, Alessandra
MARCH 2008 TO PRESENT
Institute of Maternal and Child Health IRCCS Burlo Garofolo, Trieste, Italy
Clinical Trials, Ethic Committee, Clinical Research, Clinical Pharmacology, Paediatrics
Project contract
• Main activities and responsibilities
• Dates (from – to)
• Name and address of employer
• Type of business or sector
• Occupation or position held
• Main activities and responsibilities
Page 2 - Curriculum vitae of
Maestro, Alessandra
1. Management and monitoring of clinical trials of IRCCS Burlo-Garofolo, working in the Clinical
Trials Service and the Clinical Trial Quality Team.
2. Data entry and updating of clinical trials in National Clinical Trials Observatory (OsSC) and
International Database (EudraCT)
3. Support to investigators and data managers in preparation of clinical trials documentation in
accordance with current legislation and request for additional information where required.
4. Verification of the completeness of the documentation (research protocols, amendments,
adverse events, etc..) provided by investigators (profit and no profit sponsors) for clinical trials
5.Insertion and update of data relating to clinical trials and Opinions of the Ethic Committee in
computerized records prepared by the National Observatory on Clinical Research of AIFA
(Agenzia Italiana del Farmaco) of Health Ministry.
6. Management of profit e no profit legal Agreement in collaboration with Legal Affairs Office of
IRCCS Burlo Garofolo.
7. Draw up of decrees for authorization of clinical studies in collaboration with Legal Affairs
Office of IRCCS Burlo Garofolo.
8. Draw up of appropriate forms of information and standard operative procedures about the
activities and operations of the Ethics Committee.
9. Correspondence with other Ethic Committees on issues of common interest.
10. Request to principal investigators of progress and/or closure of the studies, at least once a
year.
11. Administrative tasks of Ethic Committee of Burlo Garofolo:
- Protocol of all incoming and outgoing correspondence;
- Archive of all incoming and outgoing correspondence both in paper copy and in electronic
format;
- Registration and archiving of requests of studies, both in paper copy and in electronic format;
- Preparation of the item of the agenda, related communications and meetings for members of
the Ethic Committee;
- Drawing up reports of the minutes of meetings, sending them to Investigators and Sponsors;
- Count of attendance and assessment for the members of the Ethic Committee.
12. Verification, management, archiving and supply to investigators of Investigational Medical
Products for Clinical Trials.
13. Bibliographic research of international literature (Pub Med, MedLine, EBSCO, Up to Date) for
evaluating off-label use of drugs in children and in pregnant women.
14. Update data of off-label prescriptions.
15. Periodic monitoring of off-label prescriptions and patient’s follow-up.
January 2004- December 2004
Farmacia “Igea” di Trieste
Pharmacy
I level Pharmacist
Pharmacist
EDUCATION AND TRAINING
• Dates (from – to)
• Name and type of organization
providing education and training
• Principal subjects/occupational
skills covered
• Title of qualification awarded
• Level in national classification
(if appropriate)
• Dates (from – to)
• Name and type of organization
providing education and training
• Principal subjects/occupational
skills covered
• Title of qualification awarded
• Level in national classification
(if appropriate)
• Dates (from – to)
• Name and type of organization
providing education and training
Page 3 - Curriculum vitae of
Maestro, Alessandra
1998- 2003
University of Trieste, Faculty of Pharmacy, grade: 110/110 cum laude
Experimental Thesis in Pharmaceutical Chemistry titled “Isolamento da Stereum Hirsutum di
principi ad attività inibitoria della trombina”,
Pre-graduate Internship at IRCCS Burlo Garofolo’s hospital Pharmacy, Trieste
November 2003, qualification to exercise pharmacist practice.
Analytical Chemistry Laboratory, Medicinal analysis Laboratory, Extraction and preparation of
synthetic drugs Laboratory, Technology and Pharmaceutical Low Laboratory.
Pharmacist
Laurea Magistrale in Farmacia (5 years)
Degree
01.01.2005-10.03.2008
University of Trieste, Department of Life Sciences, section of Pharmacology, Faculty of Medicine
Thesis titled “Trasporto di flavonoidi in cellule endoteliali: ruolo della bilitranslocasi e delle
proteine ABC”
Research project under the Programme for International Mobility Erasmus during the third year
of PhD. Project Title: THERMAL LENS SPECTROSCOPY AND ITS APPLICATIONS TO
BIOLOGICAL RESEARCH " Project duration: 6 months Location: Nova Gorica Polytechnic of
University of Nova Gorica, Nova Gorica, Slovenia.
1.Dot blot, western blot, immunocytochemistry Techniques.
2.Preparation of cultures of different cell lines.
3. Studies of cellular uptake in different conditions and analysis of samples using a
spectrophotometer UV / VIS.
4. Evaluation and data analysis, graphical presentation of results.
5.Cytotoxicity assay (MTT).
6. Use of Fluorescence microscopy.
7. RNA extraction and cDNA production.
8. PCR (Polymerase Chain Reaction).
9.Collaboration in the writing a thesis of the Faculty of Medical Biotechnology titled " MESSA A
PUNTO DI UN MODELLO DI CELLULE ENDOTELIALI DI AORTA DI RATTO: STUDIO DI
TRASPORTO DELLA QUERCETINA " as co-rapporteur.
10. Collaboration in the writing of a thesis of the Faculty of Medical Biotechnology titled "
STUDIO DEL TRASPORTO DEI FLAVONOIDI NELLE CELLULE ENDOTELIALI," as corapporteur.
Laboratory training for students
Dottorato di Ricerca
Research doctorate degree (PhD) in Pharmacology, Chemotherapy and Microbiology, first
degree for Academic career
2009/2010
University of Milano Bicocca, “Preclinical and clinical drug development and research in clinical
trials”, II level Master
Thesis titled “A Clinical Trial Quality System in an Institute for Maternal and Child Health”
• Principal subjects/occupational
skills covered
• Title of qualification awarded
• Level in national classification
(if appropriate)
• Dates (from – to)
• Name and type of organization
providing education and training
• Principal subjects/occupational
skills covered
• Title of qualification awarded
• Level in national classification
(if appropriate)
• Dates (from – to)
• Name and type of organization
providing education and training
• Principal subjects/occupational
skills covered
• Title of qualification awarded
• Level in national classification
(if appropriate)
Clinical Trials
Traditional techniques and new methodology for new drugs development, principles of
pharmacokinetics, pharmacodynamics and toxicology in preclinical studies.
Stages of clinical development of drugs, methodology, planning and conduct of clinical studies,
statistic methodology applied to clinical trials,
Principles and methods of pharmacovigilance, monitor of clinical trials.
Ethical and legal aspects of clinical trials and regulatory affairs of drugs.
Clinical Research Associate Certification in accordance with Decree 15/11/2011
2nd level Master degree
Master di II livello
From 2010/2011
University of Trieste, Degree in Medicine and Surgery
Ist year (Temporarily suspended for the duration of the school in Medical Pharmacology)
Student
Student
Medical Doctor
From 2011-2016
University of Milano, School of Medical Pharmacology
Clinical Pharmacologist
Student
Specializzazione in Farmacologia Medica (5 years)
Postgraduate School in Medical Pharmacology
LANGUAGES
MOTHER TONGUE
Italian
OTHER LANGUAGES
• Reading skills
• Writing skills
• Verbal skills
English
Fluently
Good
Fluently
ADDITIONAL INFORMATION
Use of PC and Apple Macintosh and programs Word, Excel, Power Point, Internet for literature
searches on various national and international databases, Data entry and updating of clinical
trials in National Clinical Trials Observatory and International Database: EudraCT, Clinical
trials.gov.
Certifications
Qualified Person for Pharmacovigilance QPPV
Qualified Person for Pharmacovigilance (QPPV) - EMA training EudraVigilance for the electronic
transmission of Individual Case Safety Reports (ICSRs) and ICSR acknowledgements in the
context of clinical trials (SUSARs) and post-authorisation of medicinal products
Page 4 - Curriculum vitae of
Maestro, Alessandra
Page 5 - Curriculum vitae of
Maestro, Alessandra
ANNEXES
Courses attended:
Corso GIMBE “Sperimentazioni cliniche: aspetti normativi e organizzativi” - Bologna, 29-30
gennaio 2015
Corso “Il Codice della Privacy- Comportamenti e “forma mentis” per una nuova cultura della
riservatezza”, IRCCS Burlo Garofolo 19 maggio 2014.
Corso di formazione per l’utilizzo del nuovo Osservatorio Nazionale sulla Sperimentazione
Clinica dei Medicinali OsSC, nell’edizione organizzata sia per i Promotori che per i Comitati Etici,
14-16 giugno 2014, Roma.
Corso di formazione per i promotori nazionali di sperimentazioni cliniche interventistiche per
registrazione ad Eudravigilance per l’adempimento agli obblighi di legge inerenti la segnalazione
delle SUSAR, 18-20 settembre 2013 Roma.
Burlo
2:
Buon
Utilizzo
della
Ricerca
–
Letteratura
e
Operatività
dai problemi dei pazienti alle possibili risposte clinico-assistenziali e organizzative
percorso formativo sulla metodologia clinica, 2009/2010, IRCCS Burlo-Garofolo, Trieste.
“FARMACOVIGILANZA: LA SEGNALAZIONE SPONTANEA DELLE REAZIONI AVVERSE DA
FARMACO”, 15 .05.2009, IRCCS Burlo-Garofolo, Trieste.
“ASPETTI ETICI DELLA RICERCA BIOMEDICA E DELA SPERIMENTAZIONE CLINICA”,
18/03/2009, Istituto Superiore di Sanità, ROME.
“LE IMPLICAZIONI ETICHE DELLA RICERCA IN CAMPO BIOMEDICO”, 27/11/2008, IRCCS
Burlo-Garofolo, Trieste.
“II CORSO DI AGGIORNAMENTO SULLA SPERIMENTAZIONE CLINICA DEI FARMACI E DEI
DISPOSITIVI MEDICI”, 6-7th October 2008, Istituto Superiore di Sanità, ROME.
“LA RICERCA DELLA LETTERATURA IN PUBMED”, 30/10/2008, IRCCS Burlo-Garofolo,
Trieste.
“LE REVISIONI SISTEMATICHE DELLA LETTERATURA”, 19/09/2008, IRCCS Burlo-Garofolo,
Trieste.
“ANALISI DI STUDI SPERIMENTALI”, 18/09/2008,’IRCCS Burlo-Garofolo, Trieste.
“COME PREDISPORRE UN PROTOCOLLO DI RICERCA”,
Garofolo,Trieste.
02/07/2008, IRCCS Burlo-
“COLTURE CELLULARI: METODICHE DI BASE ED APPLICAZIONI”, 2-3th March 2006, Milan.
Page 6 - Curriculum vitae of
Maestro, Alessandra
PUBLICATIONS
Grisafi D, Maestro A, Grumi C, Piazzoni L, Tirone G, Fiore W, Tessari R, Gianardi V, Gatti M,
Tasca F, Generali D, Ravelli A, Lanza F, Scaglione F, Ibrutinib: from bench side to clinical
implications, Med Oncol. 2015 Sep;32(9):225. doi: 10.1007/s12032-015-0669-9. Epub 2015 Jul
30.
Maximova N, Zanon D, Rovere F, Maestro A, Schillani G, Paparazzo R, “Romiplostim for
secondary thrombocytopenia following allogeneic stem cell transplantation in children, Int J
Hematol. 2015 Jun 18. [Epub ahead of print].
D Zanon, G Schillani, A Maestro, R Paparazzo, L Ronfani, F Marchetti, F Rovere, DI-107
Creation of an Italian network for the active surveillance of off-label drug prescriptions in
paediatrics Eur J Hosp Pharm 2014;21:A113 doi:10.1136/ejhpharm-2013-000436.278
Maximova N, Pizzol A, Ferrara G, Maestro A, Tamaro P., “Does Teno Torque Virus Induce
Autoimmunity after Hematopoietic Stem Cell Transplantation? A Case Report., J Pediatr
Hematol Oncol, 17 Jun 2014.
Neri E, Maestro A, Minen F, Montico M, Ronfani L, Zanon D, Favret A, Messi G, Barbi E.,
“Sublingual ketorolac versus sublingual tramadol for moderate to severe post-traumatic bone
pain in children: a double-blind, randomised, controlled trial”, Arch Dis Child. 2013
Sep;98(9):721-4. doi: 10.1136/archdischild-2012-303527. Epub 2013 May 23
Alessandra Maestro, Davide Zanon, Rossella Paparazzo, Francesca Rovere “Clinical Trial
Quality Team: l'esperienza dell'IRCCS Burlo-Garofolo di Trieste”, Osservatorio sulle
sperimentazioni cliniche, Giornale italiano di Farmacia clinica, 25, 2, 2011.
M. Callea, F. Faletra, A. Maestro, F. Verzegnassi, M. Rabusin, A. Vinciguerra, F. Radovich, G.
Clarich, Izzet Yavuz, Emin Caner Tumen, “DENTAL PHENOTYPE IN A PATIENT WITH
HYPOIDROTIC ECTODERMAL DYSPLASIA AND SEVERE IMMUNODEFICIENCY”, Journal of
International Dental and Medical Research, Volume · 4 · Number · 1 · 2011, 17: 20.
Calligaris Lorenzo MD; Davide Zanon PharmD; Alessandra Maestro PharmD; De Bortoli,
Romina MD; Chiaretti Antonio MD; Barbi Egidio MD, CONCENTRATED MIDAZOLAM FOR
INTRANASAL ADMINISTRATION: A PILOT STUDY, Pediatric Emergency Care, Issue: Volume
27(3), March 2011, pp 245-247.
Marchetti F, Maestro A, Rovere F, Zanon D, Arrighini A, Bertolani P, Biban P, Da Dalt L, Di
Pietro P, Renna S, Guala A, Mannelli F, Pazzaglia A, Messi G, Perri F, Reale A, Urbino AF,
Valletta E, Vitale A, Zangardi T, Tondelli MT, Clavenna A, Bonati M, Ronfani L, “ORAL
ONDANSETRON VERSUS DOMPERIDONE FOR SYMPTOMATIC TREATMENT OF
VOMITING DURING ACUTE GASTROENTERITIS IN CHILDREN: MULTICENTRE
RANDOMIZED CONTROLLED TRIAL”, BMC Pediatr. 2011 Feb 10;11:15.
F. Marchetti, L. Ronfani, A. Maestro, F. Rovere, D. Zanon, A. Arrighini, P. Bertolani, P. Biban, L.
Da Dalt, P. Di Pietro, S. Renna, A. Guala, F. Mannelli, A. Pazzaglia, G. Messi, F. Perri, A. Reale,
M.T. Tondelli, A.F. Urbino, E. Valletta, A. Vitale, T. Zangardi, A. Clavenna, M. Bonati, “TRIAL
CONTROLLATO RANDOMIZZATO MULTICENTRICO DI VALUTAZIONE COMPARATIVA
DELL’ONDANSETRON VERSO DOMPERIDONE PER IL TRATTAMENTO SINTOMATICO DEL
VOMITO ACUTO DA GASTROENTERITE NEL BAMBINO: PROTOCOLLO DI STUDIO”, Medico
e Bambino pagine elettroniche 2010; 13(9).
Bava M, Bradashia F, Rovere F, Maestro A, Vecchi Brumatti L, Accardo A, Paparazzo R, Zanon
D, “A WEB-BASED SYSTEM FOR TOTAL PARENTERAL NUTRITION PRESCRIPTION IN A
PEDIATRIC HOSPITAL”, Biomed Sci Instrum. 2010;46:351-6.
Alessandra Maestro, Michela Terdoslavich, Andreja Vanzo, Adenike Kuku, Federica Tramer,
Vanessa Nicolin, Fulvio Micali, Giuliana Decorti and Sabina Passamonti, “EXPRESSION OF
BILITRANSLOCASE IN THE VASCULAR ENDOTHELIUM AND ITS FUNCTION AS A
FLAVONOID TRANSPORTER”, Cardiovasc Res. 2010 Jan 1;85(1):175-83.
Page 7 - Curriculum vitae of
Maestro, Alessandra
Alessandra MAESTRO, Michela TERDOSLAVICH, Vanessa NICOLIN, Andreja VANZO,
Giuliana DECORTI e Sabina PASSAMONTI, “L’AZIONE DEI POLIFENOLI SUL SISTEMA
CARDIOVASCOLARE E IL RUOLO DELLA BILITRANSLOCASI”, Quaderni Di Scienze Viticole
Ed Enologiche, Università di Torino, Aprile 2007.
I authorize to treat my personal data according to the Italian Low 196/2003
Trieste, January 12th, 2016
Alessandra Maestro
Page 8 - Curriculum vitae of
Maestro, Alessandra