Curriculum Vitae

PERSONAL INFORMATION Enrico Costa

WORK EXPERIENCE

October 2020- Present Head of International Affairs Department Italian Medicines Agency () Coordination of AIFAs international activities

December 2010-September 2020 Pharmacist Health Official - Hospital Pharmacy University Hospital of - Department of Pharmacy (Italy) Person in charge of the clinical governance of medicines Elaboration and drafting of evidence-based steering documents

March 2004-December 2010 Clinical Pharmacist (Contract staff) University Hospital of Verona - Department of Pharmacy (Italy) Pharmacoepidemiology, analysis and monitoring of medicines use, scientific information, drug compounding and dispensing EDUCATION AND TRAINING

January 2019- Present Professional PhD Fellow at the WHO Collaborating Centre for Pharmaceutical Policy and Regulation Utrecht University (Netherlands)

December 2003-July 2006 Post-graduate specialisation in Hospital Pharmacy (Italy)

May 2005-June 2006 Post-graduate Visiting fellow Italian Cochrane Centre - Istituto di Ricerche Farmacologiche Mario Negri - Milan (Italy)

March 2003-December 2003 Post-graduate Visiting fellow Industrial Toxicology Lab (Italy)

November 1995-June 2002 Degree in Pharmacy (Italy)

June 2001-June 2002 Visiting student - Applied Pharmacology Lab University of Bologna (Italy)

July 2000-August 2000 Visiting student Centre of Xenobiotics Research, Ninewells Hospital and Medical School - University of Dundee (United Kingdom)

ADDITIONAL INFORMATION

Expertise Analysis of Pharmaceutical policies, Haemoglobinopathies, Precision medicine and cancer, Orphan drugs and rare diseases, Pharmacoepidemiology, Drug costs and affordability, Global Health Publications Last 5 years publications 1.Costa E, Sterzi E, Tedeschi F, Casari R, Marini P, Lugoboni F. Can oral formulation increase the risk of lormetazepam abuse? Intern Emerg Med. 2020 Oct 23. doi: 10.1007/s11739-020-02538-2. [PMID: 33095413].

02/03/2021 European Medicines Agency Page 1/4 2.Costa E, Tibalinda P, Sterzi E, Leufkens HMG, Makani J, Kaale E, Luzzatto L. Making hydroxyurea affordable for sickle cell disease in Tanzania is essential (HASTE): How to meet major health needs at a reasonable cost. Am J Hematol. 2021 Jan;96(1): E2-E5. doi: 10.1002/ajh.26007. Epub 2020 Oct 6. [PMID: 32974896] 3.De Franceschi L, Costa E, Dima F, Morandi M, Olivieri O. Acute hemolysis by hydroxycloroquine was observed in G6PD-deficient patient with severe COVD-19 related lung injury. Eur J Intern Med. 2020 Jul; 77:136-137. doi: 10.1016/j.ejim.2020.04.020. Epub 2020 Apr 20. [PMID: 32381323]; 4.Costa E, Schieppati A, Luzzatto L, Remuzzi G. Drugs for rare diseases: the blessing of being orphans. Recenti Prog Med. 2019 May;110(5):221-229. doi: 10.1701/3163.31444. [PMID: 31140454] 5.Luzzatto L, Costa E, Schieppati A, Remuzzi G. Orphan drugs - Authors' reply. Lancet. 2019 Apr 20; 393(10181):1595-1596. doi: 10.1016/S0140-6736(19)30014-5. [PMID: 31007199] 6.Luzzatto L, Hyry HI, Schieppati A, Costa E, Simoens S, Schaefer F, Roos JCP, Merlini G, Kääriäinen H, Garattini S, Hollak CE, Remuzzi G. Outrageous prices of orphan drugs: a call for collaboration. Lancet. 2018 Sep 1;392(10149):791-794. doi: 10.1016/S0140-6736(18)31069-9. Epub 2018 Jul 20. [PMID: 30037734] 7.Michieli R, Avossa F, Anastasia B, Costa E, Fedeli U, Saugo M, Tognoni G. Prevenzione e assistenza primaria delle malattie cardio e cerebrovascolari nei residenti stranieri: una priorità misconosciuta. Ricerca & Pratica 2016; 32: 101-106. 8.Ostuzzi G, Benda L, Costa E, Barbui C. Efficacy and acceptability of antidepressants on the continuum of depressive experiences in patients with cancer: Systematic review and meta-analysis. Cancer Treatment Reviews 2015; 41: 714724. DOI: 10.1016/j.ctrv.2015.06.003 [PMID: 26118318] 9.Addis A, Costa E, De Palma R, Magrini N, Marata AM, Martelli L, Papini D, Traversa G. Riflessioni e confronti sui limiti e i vantaggi dei registri. Recenti Prog Med 2015; 106: 425-435. doi: 10.1701/1996.21590. [PMID: 26418504]

Projects 2020 - Principal investigator of the retrospective observational study: Evaluation of the therapeutic approach with rasburicase with respect to G6PD (rasb-G6PD) status. Approval by the Research Ethics Committee of 29/01/2020. 2018 - Coordination of the retrospective observational study on the prescription of self-injectable adrenaline in the Veneto Region (P-ADRE). Approval by the Research Ethics Committee - Code 1966CESC of 24/10/2018 2015 - HASTE Project: Hydroxyurea Affordable for Sickle patients in Tanzania is Essential. In collaboration with Muhimbili University of Health and Allied Sciences (MUHAS) - Dar Es Salaam, Tanzania - (Role: Promoter and researcher) 2015 - Research project within the Public-Private Research, Innovation and Health Technology Assessment (PRIHTA) Program: "Implementation of a system for monitoring the Recommendations of the Veneto Region Oncology Network (ROV) in lung cancer". Approved by Regional Council. Funding: 90,000 euros (Role: Co-promoter and researcher) 2014 - Promoter of the observational study: Evaluation of the efficacy and safety profile of telaprevir and boceprevir in real clinical practice. Approval by the Research Ethics Committee - Code 104CESC of 19/02/2014 2012 - Targeted Health Research Project No. 332/12: Cross-sectional and longitudinal evaluation of the appropriateness of therapy with biological drugs in patients with rheumatic diseases in the Veneto Region. Approved by Regional Council Resolution no.2980 of 28/12/2012. Funding: 165,000 euros (Role: Researcher) 2011-2013 - - National Project: Observatory on pharmaceutical prescription in the immigrant population. Cooperation between Italian Society of Hospital Pharmacy (SIFO), Italian Society of Migration Medicine (SIMM), CINECA, Mario Negri Sud Consortium (CMNS), Istituto Superiore di Sanità (ISS). (Role: Promoter and coordinator). 2011 - Research project: Study on the prevalence of patients affected by Multiple Sclerosis (Trilogy), University Hospital of Verona. Funding from Novartis Ltd: 35,000 euros (role: Researcher) 2011 - Active pharmacovigilance project: Regional technology assessment and evaluation of hospital consumption. Approved by Regional Council Resolution no. 1410 of 06/09/2011. Financed with AIFA 2008/2009 funds: 757,500 euros. (Role: person in charge of sub-project 2 - evaluation of hospital consumption) 2010-2011 - National Project: Analysis and monitoring of the guarantee of the right to health care for patients at a local level - National Observatory of the Italian Society of Hospital Pharmacy (SIFO)

02/03/2021 European Medicines Agency Page 2/4 (Role: senior researcher) 2009 2010 - SIFO-IMS National Project: Observatory on drug consumption in hospitals (Role: senior researcher) Memberships Institutional Committees / working groups Dec 2020 present:Coordinator of the Scientific Secretariat of AIFAs National Covid-19 Vaccine Surveillance Committee - Rome Sept 2015 present:Member of the Research Ethics Committee of the Istituto Oncologico Veneto - IOV (Regional Comprehensive Cancer Centre) Padova. Jul 2020 Sept 2020:Member of the working group on CAR-T Cells - University Hospital of Verona Jan 2020 Sept 2020:Member of the Coordinating Team on the HCV eradication program - University Hospital of Verona May 2019 Sept 2020:Member of the working group on Multiple Sclerosis - University Hospital of Verona Feb 2019 Sept 2020:Member of the Committee for Hospital Infections - University Hospital of Verona Oct 2018 Sept 2020:Chair of the multidisciplinary working group on appropriate prescription of cancer and blood cancer medicines - University Hospital of Verona Jun 2018 Sept 2020: Member of the working group for computerisation of the Regional Oncology Network - University Hospital of Verona Jun 2018 Sept 2020:Member of the steering committee on the HCV eradication program Veneto Region Sept 2017 Sept 2020:Chair of the working group on pharmacological treatment of HCV - University Hospital of Verona Jul 2017 Sept 2020:Member of the working group supporting the Veneto Region Therapeutic Committee on medicines for treatment of HIV infection Veneto Region Feb 2017 Sept 2020:Member of the working group supporting the Veneto Region Therapeutic Committee on chronic hepatitis C Veneto Region Jun 2016 Sept 2020:Member of the working group for definition of the Diagnostic, Therapeutic and Care path of the adult patient affected by HIV/AIDS in the Veneto Region Jan 2016 Sept 2020:Member of the Innovative medicines Working group of the Regional Oncology Network Veneto Region Dec 2013 Dec 2015:Member of the Working group supporting the Veneto Region Therapeutic Committee on blood cancer medicines Oct 2012 Jul 2013:Chair of the GLOBAL HEALTH scientific area Italian Society of Hospital Pharmacy Nov 2011 Sept 2020: Pharmacist contact point in the General Medicine Department -University Hospital of Verona Apr 2010 Jul 2013:Member of the Unit for appropriateness of drug use - University Hospital of Verona Apr 2010 Dec 2010:Coordinator of the Working Group for the development of the Guidelines for VTE in orthopaedics - University Hospital of Verona Sept 2008 Oct 2012: Chair of the INTERNATIONAL COOPERATION scientific area Italian Society of Hospital Pharmacy

Other Relevant Information Conferences and publishing activities60 Posters presented at national and international conferences 58 Speeches as speaker at national and international conferences 9 Participations in national and international conferences as discussant Organiser and scientific director of 5 national conferences Organiser and scientific director of 5 local seminars Best poster award of the 2015 conference of the Italian Society of Hospital Pharmacy Best poster award of the 2016 conference of the Italian Society of Hospital Pharmacy Co-author of 5 monographs/reports on drug prescription Member of the Editorial Support Board of the Journal of Pharmaceutical Policy and Practice Teaching and tutoring Seminars for PhDs and post-graduate specialty schools (University of Milan, University of Verona

02/03/2021 European Medicines Agency Page 3/4 and Muhimbili University) Since 2018 Lecturer of the 2nd level University Masters Degree "Regulatory Disciplines and Market Access in Pharmacy and Biotechnology, University of Piemonte Orientale Amedeo Avogadro, Novara 2014-2016 Lecturer of the Degree Course in Biotechnology. Drug metabolism (pharmacology module) - University of Verona Supervisor/co-supervisor for degree and master theses (University of Padova, University of Verona, University of Milan) Certifications Registered in the Register of Pharmacists of the Province of Verona, no. 2075 (Vol. VI) since 05/01/2004

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