Monica Santimaria - European Medicines Agency

Curriculum vitae
PERSONAL INFORMATION
Monica Santimaria
WORK EXPERIENCE
September 2014–Present
GMP Inspector
Italian Medicines Agency (Italy)
Verify compliance with the principles of good manufacturing practice (GMP) and related aspects of the
supervision of authorised medicinal products in use in the European Union.
November 2011–September 2014
Pharmacist Quality Assessor
Italian Medicines Agency (Italy)
Activities related to administrative and technical-scientific assessment of documentation submitted for:
•new Marketing Authorization requests (national procedure and community procedure)
•variations to the terms of medicinal products already authorized,
focused principally on radiopharmaceuticals.
March 2005–October 2011
Director of Clinical PET Radiopharmaceutical Production Center
Medipass S.p.a (Italy)
In charge as radiopharmacist at Policlinico “A. Gemelli” Cyclotron Facilities,
Largo Agostino Gemelli 8, 00168 Rome (Italy):
- Manage the production and quality control staff
- Planning, development and staffing of PET Nuclear Pharmacy
- Scheduling for pharmacist coverage, chemist radiopharmaceutical production and quality control of
radiopharmaceuticals.
Radiopharmacy/Radiation Safety Responsible
Synthesis, characterization of radiopharmaceuticals for Positron Emission Tomography (PET) for
clinical use.
Development, synthesis and characterization of new radiopharmaceuticals for Positron Emission
Tomography (PET) for clinical trials.
April 1998–January 2005
Self-employed Radiopharmacist
Nuclear Medicine Department at “M. Bufalini” Hospital, Cesena Nuclear Medicine Department at “S.
Bortolo” Hospital, Vicenza Nuclear Medicine Department at “Umberto I” Hospital, Mestre (Italy)
Labeling of peptides, antibodies, with Y-90 for therapy of cancer and other malignancies for clinical
use. Development of molecules for labeling with radionuclide for theraphy.
Person responsible for 2-[18F]-Fluoro-2-Deoxy-D-Glucose synthesis and quality control
September 1992–September
1995
Research Associate
University of Padua (Italy)
Research Project on “Evaluation of chemical and radiochemical issues related to synthesis and
characterization of new 99mTc and 186/188Re complexes” at Department of Pharmaceutical
Sciences, University of Padova (working group: Prof. Ulderico Mazzi).
EDUCATION AND TRAINING
2000–2003
Specialist in Hospital Pharmacy
University of Padua (Italy)
Experimental post-graduate thesis:
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Curriculum vitae
Monica Santimaria
Positron Emission Tomography Net: scientific, tecnical, organizational and regulatory aspects.
1995–1998
P.h.D. Degree in Pharmaceutical Sciences
University of Padua (Italy)
Experimental thesis:
Syntesis and characterization of a new class of bifunctional ligands -peptides containing phosphinefor labelling biomolecules with 99mTc or 186/188Re.
1984–1992
Master Degree in Pharmaceutical Chemistry and Technology
University of Padua (Italy)
ADDITIONAL INFORMATION
Expertise
Technical-scientific assessment of dossier(s) submitted for marketing authorization or variations to the
terms of medicinal products for human use under national or Community procedure.
Synthesis, characterization of radiopharmaceuticals for Positron Emission Tomography (PET) for
clinical use.
Development, synthesis and characterization of new radiopharmaceuticals for Positron Emission
Tomography (PET) for clinical trials.
Labeling of peptides, antibodies, with Y-90 for therapy of cancer and other malignancies.
Radiolabeling with Tc-99m for clinical use.
Synthesis and characterization of bifunctional chelating agents and precursors for radiolabeling of
biomolecules
Synthesis and characterization of phosphine containing ligands for Tc-99m/Re-186
Publications
Monica Santimaria, Theodosia Maina, Ulderico Mazzi, Marino Nicolini: "Preparation and
characterization of a new rhenium(V) complex containing the 3-diphenylphosphinopropionilglycyl-L(S-benzyl)-cysteinyl methyl ester ligand", Inorg. Chim. Acta, 1995, 240, 291-297.
Monica Santimaria, Ulderico Mazzi, Stefano Gatto, Alessandro Dolmella, Giuliano Bandoli, Marino
Nicolini: "Rhenium complexes with phosphine-containing peptides. Synthesis and characterization of
oxorhenium(V) complexes with N-N-[3-(diphenylphosphino)propionyl]glycyl-L-S-benzylcysteine and its
methyl ester", J. Chem. Soc.,Dalton Trans., 1997, 1765-71.
Santimaria M., Maina T., Mazzi U., Nicolini M.: "Trans-oxocloro[3diphenilphosphino)propionylglycinato-L-(S-benzyl)cysteinato methyl ester-P,N,N',S Rhenium(V):
synthesis, characterization and HPLC analysis." Technetium and Rhenium in Chemistry and Nuclear
Medicine 4, M. Nicolini, G. Bandoli, U. Mazzi Eds., SGEditoriali, Padova, Italy, pp 149-154, 1995.
Blok D., Maina T., Feitsma H., Boldrin F., Giacon M., Santimaria M., Pauwels E.J.K., Mazzi U.:
"Labelling of N-(3-diphenilphosphine)propionylglycyl-L-(S-benzyl)cysteinylmethyl ester with 99mTc;
radiochemical characterization of the 99mTc-complex." Technetium and Rhenium in Chemistry and
Nuclear Medicine 4, M. Nicolini, G. Bandoli, U. Mazzi Eds., SGEditoriali, Padova, Italy, pp 343-348,
1995.
M. Santimaria, D. Blok, R.I.J. Feitsma, U. Mazzi and E.K.J. Pauwels. Experiments on a new
phospine-peptide chelator for labelling of peptides with Tc-99m. Nuclear Medicine & Biology, 1999, 26,
251-258.
R. Visentin, M. Santimaria, M.C. Giron, U. Mazzi, M. Nicolini. A PN2S chelating system for acting as
bifunctional ligand towards 188Re and 99mTc. Technetium, Rhenium and other metals in Chemistry
and Nuclear Medicine 5, M. Nicolini, U. Mazzi Eds., SGEditoriali, Padova, Italy, 1999, 173-177.
M. Santimaria, D. Blok, R.I.J. Feitsma, U. Mazzi, E.K.J. Pauwels. 99mTc-labelling of CCK-4
(tetragastrin) by means of N-N-[3-(diphenylphosphino)propionyl]glycyl-L(S-benzyl)-cysteine as
bifunctional ligand. Technetium, Rhenium and other metals in Chemistry and Nuclear Medicine 5, M.
Nicolini, U. Mazzi Eds., SGEditoriali, Padova, Italy, 1999, 539-544.
Pietro Riva, Giancarlo Franceschi, Massimo Frattarelli, Simonetta Lazzari, Nada Riva, Giuliano
Giuliani, Michela Casi, Gabriella Sarti, Giuliano Guiducci, Gianluigi Giorgetti, Rossella Gentile, Monica
Santimaria, Eduard Jermann and Helmut Mäcke. Loco-regional radioimmunotheraphy of high grade
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Curriculum vitae
Monica Santimaria
malignant gliomas by using specific monoclonal antibodies labeled with Y-90. A phase I study. Clinical
Can. Res., 1999, 5:3275s-3280s.
P. Riva, G. Franceschi, N. Riva, M. Casi, M. Santimaria, M. Adamo. Role of Nuclear Medicine in the
tratment of malignant gliomas: the loco-regional radioimmunotheraphy approach. Eur. J. Nucl. Med.
2000, 27:601-609.
Pietro Riva, Giancarlo Franceschi, Massimo Frattarelli, Nada Riva, Giuliano Guiducci, Anna Maria
Cremonini, Giuliano Giuliani, Monica Santimaria. La radioimmunoterapia loco-regionale con anticorpi
monoclonali marcati con I-131 e Y-90 nel trattamento dei gliomi maligni ad alto grado. Rivista italiana
di Neuroscienze, n.1/2001, 71-77.
Monica Santimaria, Giovanni Moscatelli, Giuseppe L. Viale, Leonardo Giovannoni, Giovanni Neri,
Francesca Viti, Alessandra Leprini, Laura Borsi, Patrizia Castellani, Dario Neri, Luciano Zardi, Pietro
Riva. Immunoscintigraphic detection of the ED-B domain of fibronectin, a marker of angiogenesis, in
patients with cancer. Clinical Cancer Res. 2003, 9:571-579.
D. Rubello, D. Casara, G. Saladini, M. Santimaria, A. Maran, A. Tiengo. Role of sequential 3-phase
bone scintigraphy and Leukoscan® in evaluating total knee prosthesis (TKP) infection. The
Quaternarly J. of Nuclear Medicine and Molecular Imaging. 2004, 48, suppl. 1 to issue n. 4.
Stefano Boschi, Monica Santimaria. NOTIZIARIO DI MEDICINA NUCLEARE ED IMAGING
MOLECOLARE. Proposta di protocolli essenziali a valenza nazionale per i controlli di qualità dei
radiofarmaci PET Anno I I , n. 3 - Giugno 2006 - Supplemento Speciale
Monica Santimaria. Classificazione delle preparazioni radiofarmaceutiche. Notiziario di medicina
nucleare e d imaging molecolare. Anno V, n. 4 - Ottobre 2009
Monica Santimaria I radiofarmaci in terapia. Bollettino SIFO Volume 51 Numero 4 Luglio-Agosto 2005.
A.L. Viglietti, L. Uccelli, N. Rutigliani, M. Santimaria. Sterilità e asepsi: metodologie, convalide e
verifiche. La qualità nella preparazione dei radiofarmaci, a cura di Giovanni Lucignani, Springer-Verlag
Editoriali, Italia. 2011.
Mara Migliazza, Alessandro Giordano, Chiara Franciosi, Monica Santimaria, Flavio Vinci. La
diagnostica PET-TAC: studio per il miglioramento del processo e della sicurezza attraverso la
collaborazione tra pubblico e privato. Sanità Pubblica e Privata, numero 2 , marzo-Aprile 2011.
Treglia G, Castaldi P, Villani MF, Perotti G, de Waure C, Filice A, Ambrosini V, Cremonini N,
Santimaria M, Versari A, Fanti S, Giordano A, Rufini V. Comparison of 18F-DOPA, 18F-FDG and
68Ga-somatostatin analogue PET/CT in patients with recurrent medullary thyroid carcinoma. Eur J
Nucl Med Mol Imaging. 2012 Apr; 39(4):569-80.
A. Giordano, M. Santimaria. Capitolo 27. Diagnostica per immagini. Medicina Nucleare. Radioterapia
diretto da: N. Villari - G. Biti - C. Fava - A. Giordano - B. Belmonte Zobel. Ed. PICCIN 2011.
P. Minghetti, M. Santimaria, A. D’Arpino. Classificazione dei radiofarmaci. Sperimentazione e
registrazione dei radiofarmaci. Imaging & Formazione 2013, pp 39-46
Projects
Memberships
2008-2013: Member of the Precursors for Radiopharmaceutical Preparations Group of Expert at
EDQM (European Pharmacopeia)
2009-2001: Member of the Working Party on Radiopharmaceuticals at Agenzia Italiana del Farmaco
Other Relevant Information
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