Domenico Di Giorgio - European Medicines Agency

Curriculum Vitae
PERSONAL INFORMATION
Domenico Di Giorgio
WORK EXPERIENCE
December 1995–April 2004
Senior Chemist Officer; GMP inspector
Ministry of Health, (Italy)
SECTOR: Pharmacoeconomics, GMP, Counterfeit medicines, Council of Europe
ACTIVITIES: Pharmaceuticals Prices office and Pharmaceutical General Directorate of MoH (19962002): database handling, pharmacoeconomic studies, price negotiation issues, data publications
Good Manufacturing Practice for Pharmaceuticals (GMP) Inspectorate of MoH (1996-2004 part time):
over 100 GMP inspections performed as a team leader
Italian member of Council of Europe “Experts on pharmaceutical questions” and “Experts on
medicines subject to prescription” committees (2002-2004): activities and projects on fight against
counterfeit medicines, safe prescription, internet & medicines, pharmaceuticals classification and
reimbursement
Related document(s):
April 2004–December 2009
Senior Chemist Officer; GMP inspector
AIFA - Italian Medicines Agency, (Italy)
SECTOR: GMP for APIs, Counterfeit Medicines, Training, Council of Europe, WHO
ACTIVITIES: General Directorate of AIFA- Pharmaceutical National Italian Agency:
database handling, data publications, training for enforcement officers, projects on fight to medicines
counterfeiters (in cooperation with World Health Organization), publications, law enforcement,
negotiation of EU Directive 2011/62 (since 2009)
Good Manufacturing Practice for Active Pharmaceuticals Ingredients (GMP for APIs) Inspectorate of
AIFA: over 20 GMP inspections performed as a team leader
Italian member of Council of Europe/EDQM groups on pharmaceuticals: chairman (elected for 20082010) of the European Committee on Pharmaceuticals and Pharmaceutical Care, and of the
Committee of Experts on minimising public health risks posed by counterfeiting of medical products
and related crimes: activities and projects on fight against counterfeit medicines, pharmaceuticals
classification and reimbursement
Italian member of World Health Organization task force “IMPACT – International Medicinal Products
Anti Counterfeiting Task-force”, fighting against Counterfeit Medicines
Coordinator of the Anti Counterfeiting & Concil of Europe related Activities for AIFA (2007); member of
the Anti Counterfeiting National Task-force (2007)
Related document(s):
January 2010–Present
Director of the Counterfeit Prevention Unit
AIFA - Italian Medicines Agency, (Italy)
SECTOR: Counterfeit medicines, Training, Council of Europe, WHO, Internet , IT Intelligence,
Publications, Risk Communication,
ACTIVITIES: General Directorate of AIFA- Pharmaceutical National Italian Agency: database
handling, data publications, training for enforcement officers, projects on fight to medicines
counterfeiters (in cooperation with Council of Europe and World Health Organization), IT intelligence,
risk communication, publications, law enforcement, negotiation of EU Directive 2011/62 (2009-2011)
Italian member of Council of Europe/EDQM groups on pharmaceuticals: chairman (elected for 20112013) of the European Committee on Pharmaceuticals and Pharmaceutical Care, and of the
Committee of Experts on minimising public health risks posed by counterfeiting of medical products
and related crimes: activities and projects on fight against counterfeit medicines, pharmaceuticals
classification and reimbursement
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Curriculum Vitae
Domenico Di Giorgio
Italian member and interim secretariat of World Health Organization task force “IMPACT –
International Medicinal Products Anti Counterfeiting Task-force”, fighting against Counterfeit Medicines
Coordinator of the Anti Counterfeiting & Concil of Europe related Activities for AIFA; member of the
Anti Counterfeiting National Task-force
Consultant of the Italian Senate (e-pharmacies and counterfeit medicines, 2010-2011).
Coordinator of the national task-force IMPACT Italia and of the “Pharmaceuticals and Cosmetics”
working group at the National Anti-Counterfeiting Council (since 2011)
Coordinator of the EU Projects FAKESHARE (since 2013) and FAKESHARE 2 (since 2014); AIFA
coordinator of the EU Project FAKECARE (since 2012).
Related document(s):
EDUCATION AND TRAINING
September 1984–February 1990
Degree in Chemistry (specialization in biochemistry)
University of Rome “La Sapienza”, (Italy)
Analytical biochemistry (chromatography, HPLC, fluorimetry, spectrophotometry), microbiology,
structuristic and molecular dynamics techniques for peptides, enzymes, proteins (NMR, mass
spectroscopy, sequencing). Production, isolation and purification of peptides (toxins, bacterial
metabolites). Evaluation: 110/110 cum laude.
Related document(s):
September 1991–October 1994
Ph. D in Biochemistry
University of Rome “La Sapienza” , (Italy)
Experiences during the Ph. D. course: mass spectroscopy in the University of Naples “Federico II”;
NMR in CNR research center "G. Giacomello", Montelibretti; plant physiology in the labs of Utah State
University, Logan, USA.
Related document(s):
January 1997–December 1997
Specialisation Course in Pharmacoeconomy
University of Rome “La Sapienza” , (Italy)
Pharmacoeconomy
Related document(s):
April 1999–May 1999
Training course as GMP Investigator
Food & Drug Amministration , (United States)
GMP for pharmaceutical and Active Pharmaceutical Ingredients manufacturing. Evaluation, 87/100.
Related document(s):
ADDITIONAL INFORMATION
Expertise
Publications
Pharmaceutical crime and investigations; Counterfeit medicines; Inspections (GMP/Counterfeiting);
Internet pharmacies and IT Intelligence; EC Projects; Publications
Publications: books
* Combating Counterfeit Drugs (D. Di Giorgio, V. Reggi ed., Acts of the AIFA-WHO International
Conference, Rome, 2006).
* Counterfeit medicines: facts and practical advice (D. Di Giorgio ed., Council of Europe/EDQM
publishing, 2008)
* Counterfeit medicines: facts and practical advice (D. Di Giorgio ed., Council of Europe/EDQM
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Curriculum Vitae
Domenico Di Giorgio
publishing, 2009)
* Counterfeit medicines: case studies (D. Di Giorgio ed., Council of Europe/EDQM publishing, 2009)
* Counterfeit medicines: exercises (D. Di Giorgio ed., Council of Europe/EDQM publishing, 2009)
* Farmaci contraffatti: il fenomeno e le attività di contrasto (D. Di Giorgio ed., Tecniche Nuove,
AIFA/EDQM publishing: ISBN 978-88-481-2553-6 , 2010)
* Contraffazione ed e-commerce farmaceutico: indagine conoscitiva (consulenza, D. Di Giorgio;
Senato della Repubblica, 2010)
* IMPACT (International Medical Products Anti-Counterfeiting Taskforce) – The Handbook, book + CD
ROM (D. Di Giorgio ed., Tecniche Nuove/AIFA: ISBN 978-88-481-2646-5, 2011)
* Counterfeit medicines: facts and practical advice, revised ed. (D. Di Giorgio ed., Tecniche Nuove,
AIFA/EDQM publishing: ISBN 978-88-481-2657-1 , 2011)
* Counterfeit medical products and similar crimes: risk communication (D. Di Giorgio ed., Tecniche
Nuove, AIFA/EDQM publishing: ISBN 978-88-481-2662-5, 2011)
* Counterfeit medical products and similar crimes: case studies, volume II (D. Di Giorgio ed., Council
of Europe/EDQM publishing, 2011)
* Counterfeit medical products and similar crimes: risk communication - Proceedings (D. Di Giorgio
ed., Tecniche Nuove, AIFA/EDQM publishing: ISBN 2012)
* Crimine farmaceutico: guida per gli operatori (D. Di Giorgio e M. Gramazio ed., AIFA/Infarmed, 2014,
in press)
Publications: articles
* Cercospora beticola toxin: a reassessment of some in vitro effects. (P.Aducci, M.L.Cozzella, D.Di
Giorgio, V.Fogliano & M.Marra, Plant Science 84,1992, 53-57)
* Toxins of Pseudomonas syringae pv. syringae affect H+-transport across the plasma membrane of
maize. (D. Di Giorgio, L. Camoni & A. Ballio, Physiologia Plantarum 91, 1994, 741-746).
* Novel bioactive lipodepsipeptides from Pseudomonas syringae; the pseudomycins. (A. Ballio, F.
Bossa, D. Di Giorgio, P. Ferranti, M. Paci, P. Pucci, A. Scaloni, A.L. Segre & G. Strobel, FEBS Letters
355,1994, 96-100).
* Saprophytic Pseudomonas syringae strain M1 of wheat produces cyclic lipodepsipeptides (F.C.
Adetuyi, A. Isogai, D. Di Giorgio, A. Ballio & J.Y. Takemoto, FEMS Microbiology Letters 131, 1995, 6368).
* Pseudomonas syringae pv. syringae phytotoxins reversibly inhibit the plasma membrane H+ATPase and disrupt unilamellar liposomes. (L. Camoni, D. Di Giorgio, M. Marra, P. Aducci & A. Ballio,
Biological and Biochemical Research Communications 214, 1995, 118-124)
* Solution conformation of the Pseudomonas syringae pv. syringae phytotoxic lipodepsipeptide
syringopeptin 25-A: 2d nmr, distance geometry and molecular dynamics (A. Ballio, F. Bossa, D. Di
Giorgio, A. Di Nola, C. Manetti, M. Paci, A. Scaloni & A. L. Segre, European Journal of Biochemistry
234, 1995, 747-758).
* Mechanism of action of pseudomycins (D. Di Giorgio, L. Camoni, C. Marchiafava & A. Ballio,
Giornale Botanico Italiano 129, 1995, 1056-1057)
* Effect of syringomycin-E and syringopeptins on isolated plant mitochondria (D. Di Giorgio, P.
Lavermicocca, C. Marchiafava, L. Camoni, G. Surico & A. Ballio, Physiological and Molecular Plant
Pathology 48, 1996, 325-334).
* Production of syringomycins and syringopeptins by Pseudomonas syringae pv. atrofaciens. (V.
Vassilev, P. Lavermicocca, D. Di Giorgio & N.S. Iacobellis, Plant Pathology, 45, 1996, 316-322)
* Structure of fuscopeptins, phytotoxic metabolites of Pseudomonas fuscovaginae (A. Ballio, F. Bossa,
L. Camoni, D. Di Giorgio,M.-C. Flamand, H. Maraite, G. Nitti, P. Pucci & A. Scaloni, FEBS Letters 381,
1996, 213-216)
* Syringopeptins, Pseudomonas syringae pv. syringae phytotoxins, resemble syringomycin in closing
stomata (D. Di Giorgio, L. Camoni, K.A. Mott, J.Y. Takemoto & A. Ballio, Plant Pathology 45, 1996,
564-571)
* Pore forming activity of lipodepsipeptides from Pseudomonas syringae (M. Dalla Serra, P. Nordera,
G. Fagiuoli, I. Bernhart, D. Di Giorgio, A. Ballio, G. Menestrina, Med. Microb. Immunol. 185, 1996,
107)
* Biological activities of pseudomycin A, a lipodepsinonapeptide from Pseudomonas syringae MSU
16H. (D. Di Giorgio, L. Camoni, C. Marchiafava & A. Ballio, Phytochemistry 45, 1997, 1385-1391)
* A new syringopeptin produced by a Pseudomonas syringae pv. syringae strain isolated from
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Curriculum Vitae
Domenico Di Giorgio
diseased twigs of laurel (A. Scaloni, L. Camoni, D. Di Giorgio, M. Scortichini, R. Cozzolino & A. Ballio,
Physiological and Molecular Plant Pathology 51, 1997, 259-264)
* Lipodepsipeptides from Pseudomonas syringae pv. syringae (R.C. Bachmann, A. Ballio, D. Barra, F.
Bossa, L. Camoni, D. Di Giorgio, A. Di Nola, P. Ferranti, I. Grgurina, N.S. Iacobellis, P. Lavermicocca,
C. Manetti, C. Marchiafava, G. Marino, K.A. Mott, M. Paci, P. Pucci, A. Scaloni, A. Segre, M.
Simmaco, G.A. Strobel, G. Surico & J.Y. Takemoto, A. Ballio, in "Pseudomonas syringae pathovars
and related pathogens. Developments in Plant Pathology Series", K. Rudolph, T.J. Burr,
J.W.Mansfield, D. Stead, A. Vivian, J. von Kietzell - Kluwer, eds, Academic Publishers, Dordrecht, The
Netherlands 1997, pp.170-175).
* Studies on the effect of syringomycin and syringopeptins on the functions of plant mitochondria (P.
Lavermicocca, A. Ballio, L. Camoni, D. Di Giorgio & C. Marchiafava, in "Pseudomonas syringae
pathovars and related pathogens. Developments in Plant Pathology Series", K. Rudolph, T.J. Burr,
J.W.Mansfield, D. Stead, A. Vivian, J. von Kietzell - Kluwer, eds, Academic Publishers, Dordrecht, The
Netherlands 1997, pp.198-201).
* A new syringopeptin produced by a Pseudomonas syringae strain from laurel (D. Di Giorgio, L.
Camoni, A. Scaloni, M. Scortichini & A. Ballio, in "Pseudomonas syringae pathovars and related
pathogens. Developments in Plant Pathology Series", K. Rudolph, T.J. Burr, J.W.Mansfield, D. Stead,
A. Vivian, J. von Kietzell - Kluwer, eds, Academic Publishers, Dordrecht, The Netherlands 1997,
pp.208-209).
* Syringomycin and syringopeptins in the basal glume rot of wheat incited by Pseudomonas syringae
pv. atrofaciens (V. Vassilev, P. Lavermicocca, D. Di Giorgio & N. S. Iacobellis, in "Pseudomonas
syringae pathovars and related pathogens. Developments in Plant Pathology Series", K. Rudolph, T.J.
Burr, J.W.Mansfield, D. Stead, A. Vivian, J. von Kietzell - Kluwer, eds, Academic Publishers,
Dordrecht, The Netherlands 1997, pp.210-214).
* Corpeptins, new bioactive lipodepsipeptides from cultures of Pseudomonas corrugata (M. C.
Emanuele, A. Scaloni, P. Lavermicocca, N.S. Jacobellis, L. Camoni, D. Di Giorgio, P. Pucci, M. Paci,
A. Segre & A. Ballio, FEBS Letters 433, 1998, 317-320)
* The interaction of lipodepsipeptide toxins from Pseudomonas syringae pv. syringae with biological
and model membranes: a comparison of syringotoxin, syringomycin, and two syringopeptins (M. Dalla
Serra, G. Fagiuoli, P. Nordera, I. Bernhart, C. Della Volpe, D. Di Giorgio, A. Ballio & G. Menestrina,
Molecular Plant-Microbe Interactions 12, 1999, 391-400)
* Conductive properties and gating of channels formed by syringopeptin 25a, a bioactive
lipodepsipeptide from Pseudomonas syringae pv. syringae, in planar lipid membranes (M. Dalla Serra,
I. Bernhart, P. Nordera, D. Di Giorgio, A. Ballio & G. Menestrina, Molecular Plant-Microbe Interactions
12, 1999, 401-409)
* The experience of CIPE (A. Messori, S. Trippoli, P. D'Alessandro, D. Di Giorgio & F. Tosolini, Journal
of American Medical Association 284, 2000, 1923)
* The pricing system and control of expenditure in Italy (D. Di Giorgio, in "Drug market and public
health policy", S. Pappagallo & A. Germani – Ministry of Public Health of Lebanon. Beirut, Lebanon,
2002, .85-96).
* Cure on line: vademecum italiano per l’UE (D. Di Giorgio, Il Sole 24 Ore, 2008)
Projects
Memberships
Other Relevant Information
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