Curriculum Vitae Merck Serono Ivrea RBM S.p.A. Updated 21/10/2014

Transcript

1 Curriculum Vitae Merck Serono Ivrea RBM S.p.A. Updated 21/10/2014 Rita Bussi GLP Test Facility Manager Deputy Managing Director Site Compliance Officer and Security Officier, Facility Animal Welfare Responsible as per D.L.vo 4 marzo 2014 n.26 (EU Directive 2010/63) Address(es) Via Ribes, 1 Telephone(s) Mobile: Fax(es) rita.bussi@merckgroup.com Nationality Italiana WORK EXPERIENCE 1978 Teacher of biological sciences Istituto Tecnico di Stato "Luigi Burgo", Torino Associate to chemical-clinical analysis laboratory. Responsible for hematological and urinalysis and writing the pertinent RBM SOPs. Performed caesarean section on rats, on rabbits, necropsies on adult and pups and all fetal examinations in teratology studies RBM Istituto di Ricerche Biomediche "A. Marxer" Via Ribes, Colleretto Giacosa (TO), Italy Ad interim responsible for the chemical-clinical laboratory. Performed behavioral tests in reproductive studies. Participated in reviewing and writing the SOPs for the teratology and reproductive studies. Study director for teratology and reproductive studies. RBM Istituto di Ricerche Biomediche "A. Marxer" 1984 Responsible for marmoset colony. RBM Istituto di Ricerche Biomediche "A. Marxer" Page 1/17 - Curriculum vitae of Rita Bussi Signature

2 Researcher - Reproductive Toxicology Unit Head. Responsible for conducting all phases of teratology and reproductive studies from the preparation of the protocol to the final report. RBM Istituto di Ricerche Biomediche "A. Marxer" 1990 On invitation: Lecture on "Reproductive Toxicology: Practical and Regulatory Aspects" University of Hanghzou - People's Republic of China On invitation: Lecture on "Reproductive Toxicology: Methodology and Regulatory Aspects" University of Bologna, Italy On invitation: Faculty member of third summer school on risk assessment I.U.T.O.X. Capri, Italy Reproductive Toxicology and Biological Quality Control Unit Head. Responsible for conducting all phases of teratology and reproductive studies from the preparation of the protocol to the final report. Responsible for conducting all phases of the biological assays and accessory tests for the quality control of the pharmaceutical products (gonadotropines). RBM Istituto di Ricerche Biomediche "A. Marxer" Taking part of the ETS Male Fertility Working Group Taking part of the Italian Nomenclature Working Group [Publication of the work done on Teratology 55: (1997) Terminology of Development Abnormalities in Common Laboratory Mammals (Version 1)] Reproductive Toxicology and Biological Quality Control Unit Head. RBM Centralized Pharmacy Head. On invitation: Lecture on Reproductive Toxicology and more recent Guidelines University of Turin, Italy 1998 Senior Scientist for Reproductive Toxicology On invitation: Lecture on Reproductive Toxicology Educational Course on Physiopathology of reproduction and techniques of assisted reproduction Associazione Biologi Piemonte Page 2/17 - Curriculum vitae of Rita Bussi Signature

3 On invitation: Lecture on Reproductive Toxicology University of Turin, Italy 1999 Management Team Leader for Reproductive Toxicology and Biological Q.C. Unit and Biotechnology Unit. RBM Istituto di Ricerche Biomediche "A. Marxer" On invitation: Lecture on Reproductive Toxicology University Diploma Course University of Turin, Italy Jan Director of Operations for Pathology, Pharmacy, Maintenance, Planning, IT, Environmental Health and Safety and Regulatory Affairs RBM Istituto di Ricerche Biomediche "A. Marxer" Apr Jan General Manager, acting RBM Istituto di Ricerche Biomediche "A. Marxer" Jan Director of Operations for Pathology, Pharmacy, Maintenance Planning, IT, Environmental Health and Safety, Regulatory Compliance and External Studies and Veterinary Service Responsible for animal use at RBM RBM Istituto di Ricerche Biomediche "A. Marxer" Nov March 2009 Site Management Director, Responsible for Maintenance, Warehouse and General Services, Purchasing, Information and Communication Technologies, Security, Environmental Health and Safety as per D.L. 626, Responsible for animal use at RBM as per D.L. 116, External Relations. Scientific activities Director, responsible for Centralized Pharmacy, External Studies and Veterinary Sciences, Planning, Outsourcing and Editing, Regulatory Compliance and Contracts RBM Istituto di Ricerche Biomediche "A. Marxer" March 2009 present Deputy Managing Director RBM Istituto di Ricerche Biomediche "A. Marxer" June 2010 On invitation: Lecture on Master in Ricerca e Sviluppo Preclinico e Clinico dei Farmaci Master di 2 livello, Modulo III 2th Edizione Università Bicocca Milano Page 3/17 - Curriculum vitae of Rita Bussi Signature

4 June 2011 June 2012 May 2013 June 2013 On invitation: Lecture on Master in Ricerca e Sviluppo Preclinico e Clinico dei Farmaci Master di 2 livello, Modulo III 3th Edizione Università Bicocca Milano On invitation: Lecture on Master in Ricerca e Sviluppo Preclinico e Clinico dei Farmaci Master di 2 livello, Modulo III 4th Edizione Università Bicocca Milano Site Compliance Officer and Site Security Officier Responsible for Animal Use at RBM as per D.L. 116 RBM Istituto di Ricerche Biomediche "A. Marxer" On invitation: Lecture and Coordinator of Master in Ricerca e Sviluppo Pre-clinico e Clinico dei Farmaci Master di 2 livello, Modulo III 5th Edizione Università Bicocca Milano November 2013 "INDUSTRIAMOCI nel Canavese" promossa dal Comitato Piccolo Industria di Confindustria Canavese Visita guidata al sito di una classe di terza media del Comprensorio di Ivrea July 1, 2014 present GLP Test Facility Manager Deputy Managing Director Site Compliance Officer and Security Officier Facility Animal Welfare Responsible as per D.L.vo 4 marzo 2014 n.26 (EU Directive 2010/63) EDUCATION QUALIFICATION(S) AWARDED 1977 Doctorate degree in Biological Sciences University of Torino TECHNICAL AND MANAGERIAL COMPETENCIES 30 years experience in research in the field of Preclinical Development with a particular focus in Reproductive Toxicology. Senior Scientist for Reproductive Toxicology as requested by the Italian Ministry of Health. Large managerial experience with many groups both scientific and non scientific. LANGUAGE(S) Italian: eg.mother tongue English: Good French: Very good Page 4/17 - Curriculum vitae of Rita Bussi Signature

5 1979 Course on Clinical Biology at Torino University 1983 Biological assays of FSH, LH and HCG at the Istituto Farmacologico Serono, Roma 1984 Course on Drug and Food Additives Toxicology, Società Italiana di Tossicologia, Milano 12th Course on Toxicology, RBM, Saint Vincent 1987 Second summer school on risk assessment I.U.T.O.X, Washington - USA 1989 Seminar on "Management for change" ARES SERONO GROUP TRAINING CENTER Loranzè (TO) - Italy 1990 Seminar on "Differentiation of the gonads" Societé Française de Teratologie, Paris - France TECHNICAL AND MANAGERIAL TRAINING 1991 Seminar on "Intermediate Course of Management" Ares Serono Group Training Center Loranzè (TO) - Italy 1992 Course on management RBM, Ivrea - Italy 1997 European School on Risk Assessment for Reproduction Firenze - Italy 2001 Mini Babsoon Course, Boston USA 2003 Leading successful project, Paris 2004 Strategic Company Communications - Studio Ambrosetti, Milano The Future of Research in Italy - Fondazione Cariplo, Milano Learning from the Leaders Cegos, Firenze Six days course on D.L.626/94 Igiene e Sicurezza sul lavoro Coaching, people management and goals setting - RBM Lago d Orta Page 5/17 - Curriculum vitae of Rita Bussi Signature

6 2005 Environmental Management Seminar Serono - Vevey World Business Forum - Milano 2006 Team Building Logos Comunica Castello di San Giorgio, June e 4 July chiusura presso la Foresteria di Loranzé La Responsabilità Sociale e il Bilancio di Sostenibilità Istituto Internazione di Ricerca, Roma, July 2007 Imprenditrici in Europa: un progetto di rete per rafforzare il business al femminile Torino, Centro CongressiLingotto, 23 October Non-Clinical Drug Safety Evaluation and Drug Development BioIndustry Park Canavese Colleretto Giacosa (TO) 2008 Workshop Comunicazione: Saper Comunicare per Dirigere Ruta di Camogli (SP), June 2 Incontro nel Canavese Industria e turismo per il canavese AIDDA, Castello di San Giorgio Canavese, 2 July Decision Making Course Merck Serono RBM, HR Saint Vincent (AO), December 2009 World Business Forum: Formare, anticipare e reinventarsi Milano, November 2010 Incontro dibattito in tema di sicurezza sul lavoro: Processo al Rischio - CEPER Milano, 27 January 2011 Efficienza e flessibilità nei processi e nelle persone Ambrosetti, Torino, 15 February Efficienza Energetica e Opportunità per le imprese Ambrosetti, Torino, 21 September Workshop per Imprenditrici AIDDA Corporate Governance e la Legge 120/2011 Roma, Giugno 2013 I Dibattiti Aperti nella Sperimentazione Animale: Innovazione e Formazione Istituto Zooprofilattico Sperimentale della Lombardia e dell Emilia Romagna, Gargnano del Garda, Maggio Page 6/17 - Curriculum vitae of Rita Bussi Signature

7 2014 Sperimentazione animale e diritto alla conoscenza e alla salute. Ciclo di incontri Scienza, Innovazione e Salute, Senato della Repubblica Roma XXIII Congresso Nazionale GIQAR Gestione del Cambiamento nelle GxP: incontro tra industria ed autorità regolatorie Ospedaletto di Pescantina (VR), Giugno ConvegnoAISAL Riflessioni, Risvolti e Risposte: 3R per comprendere il DLgs 26/2014 Roma, 27 Giugno Seminario SSFA RTC BPL Nuova Scheda Riassuntiva delle caratteristiche del centro di saggio ai fini della certificazione di conformità secondo quanto stabilito dal D.L. 50 del 02/03/2007 Pomezia, 19 Novembre Page 7/17 - Curriculum vitae of Rita Bussi Signature

8 ORIGINAL PAPER, CONGRESSES and LECTURES th International Symposia on Clinical Enzymology, Verona st National Meeting on Experimental Teratology, Milano University rd National Meeting on Primatology, Torino University 12th Conference of European Teratology Society, Holland 2nd National Meeting on Experimental Teratology, Milano University th Congress of European Toxicology Society, Finland International Symposium-Workshop "Pharmacokinetics in Teratogenesis", West Berlin 13th Conference of European Teratology Society, East Germany Meeting on "Dosimetria ed effetti biologici dei campi elettromagnetici a radiofrequenze", Ivrea 1986 Ivrea (I) RBM Meetings 1 Receptors in Pharmacology Round Table: "La relazione dell'esperto nella procedura multi-stato", Milano Meeting on "Valutazione del rischio tossicologico: sperimentazione in "vivo" e possibili alternative", Milano University 27th Congress of European Society of Toxicology, United Kingdom 14th Conference of European Teratology Society, Denmark Page 8/17 - Curriculum vitae of Rita Bussi Signature

9 VII National Congress of the Italian Toxicological Society, Bari Ivrea (I) RBM meetings 2 Topics in Reproductive Toxicology 1987 Meeting of the Société Française de Teratologie - Paris Conference on "Responsability of Management and of Quality Assurance under GLP's" - Milano Meeting of the "Société Française de Teratologie on Behavioral Teratology" - Orlèans 15th Conference of European Teratology Society, Fribourg Switzerland Ivrea (I) RBM Meetings 3 Toxicity testing: Hepatic alterations 1st. GISAL - Meeting "La professionalità degli operatori nell'animal care "SSFA - Milano" 1988 Italy-USA International Symposium on "Perinatal Biology" - Istituto Superiore di Sanità - Roma Utilization des techniques in vitro en Teratologie- Société Nationale de Teratologie Française - Paris 16th Conference of European Teratology Society Secretary for Local Organizing and Scientific Commettee Baveno - Italy Milano (I) RBM Meetings 4 Trends in Drug Development 1989 Réunion annuelle de la Société Nationale de Teratologie Paris - France Practical in vitro Toxicology. Second international Conference Nottingham England 17th Conference of European Teratology Society Budapest (Hungary) Page 9/17 - Curriculum vitae of Rita Bussi Signature

10 5th RBM Meeting Safety tests for the Notification of new chemicals: EEC Directive 79/ th Conference of European Teratology Society Edinburgh (UK) th Conference of European Teratology Society Antwerpen (Belgium) th Conference of European Teratology Society Wurzburg ( Germany) 1993 Sperimentazione animale: etica e criteri di conduzione. Santa Margherita Ligure (Italy) 21st Conference of European Teratology Society Lyon - France RBM Meeting: Toxicokinetics: The Approach, Design and Objectives Milano - Italy Giornate studio - Gruppo Scientifico Italiano Studi e Ricerche: Studi Preclinici, nuovi orientamenti scientifici e Regolatori Milano Italy nd Conference of the European Teratology Society Prague - Czech Republic IV Symposium on vertebrate Whole Embryo Culture Milano (Chairman and member of the Local Organizing Committee) rd Conference of the European Teratology Society Dublin (Ireland) II Congresso Nazionale di Cell-Tox, Ivrea (Italy) 1996 Giornata di Studio - Il processo di armonizzazione delle normative dopo ICH3 organized by SSFA, Milan (Italy) 24th Conference of the European Teratology Society, Rome (Italy) Member of the Local Organizing Commmittee th Conference of European Teratology Society Cannes (France) Page 10/17 - Curriculum vitae of Rita Bussi Signature

11 th Conference of European Teratology Society Stockholm (Sweeden) Workshop on Implantation Factors Geneva (Switzerland) 1999 FDA/Industry Meeting on Preclinical Assessment of Reproductive Toxicity Data. Rockville (USA) 27 th Conference of European Teratology Society Oxford (UK) th Conference of European Teratology Society Ferrara (I) Member of the Local Organizing Commettee th Conference of European Teratology Society, Hamburg (Germany) - Council Member th Conference of the European Teratology Society Hannover (Germany) Citokines and Interferons 2002 Torino (Italy) 2004 International Primate Society Symposium, Torino (Italy) 2007 XVI Congresso Nazionale GIQAR Mondello (PA), May Merck International Purchasing Conference and Launch of Global Purchasing Network Frankfurt, 3-5 July Dissemination strategies: How do they influence the uptake of new 3Rs methods across laboratories/boundaries? EPAA Lyon, 1-2 October EPAA Annual Conference Brussels, 5-6 November Merck Serono International Animal Science and Welfare Meeting Darmstadt,3-4 December XVII Congresso Nazionale GIQAR Genova, June Page 11/17 - Curriculum vitae of Rita Bussi Signature

12 2008 OECD Event Roma, 9-11 April OECD Event Ivrea (TO), 15 May EHS Forum 2008 Europe Merck Darmstadt, June 2 nd IASW Meeting Merck Serono Grafing, Germany, October 2010 XIX Congresso Nazionale GIQAR Sirmione, Italy, May NCD Day Darmstadt, Gernamy, June R&D Day Geneva, Switzwerland, 30 September 2011 XX Congresso Nazionale GIQAR 2012 Roma, May 2012 XXI Congresso Nazionale GIQAR 2012 Torino, May Conferenza: L Etica della Comunicazione Dott. Alberto Sinigaglia, Presidente dell Ordine dei giornalisti del Piemonte e redattore capo ed editorialista de La Stampa - Torino, 20 June 6 Forum Cultura D Impresa Talenti Contro la Crisi Leadership al femminile, giovani e multiculturalità Gruppo 24 ore Milano, 12 dicembre 2013 Chinese Health Market: Opportunities for European Players Bioindustry Park, Colleretto Giacosa (TO) 31 gennaio Il Laboratorio Clinico: Aggiornamenti Regolatori e Linee Guida SSFA, Milano 1 febbraio I dibattiti aperti nella sperimentazione animale: innovazione e formazione Istituto Zooprofilttico Sperimentale della Lombardia e dell Emilia Romagna Palazzo Feltrinelli, Gargnano del Garda maggio Page 12/17 - Curriculum vitae of Rita Bussi Signature

13 Convegno: Dare una prospettiva all economia italiana: Impresa, Finanza AIDDA Palazzo Isimbardi-Provincia, Milano 7 giugno La Sicurezza sul lavoro dopo la legge 98/2013 tra semplificazioni e adempimenti sostanziali Tutte le novità sul DUVRI, DVR, POS, PSC, fascicolo dell opera. Comunicazioni e notifiche Ivrea 7 ottobre La Gestione del dato elettronico e dei sistemi informatici in ambito regolato Bioindustry Park Silvano Fumero Colleretto Giacosa 10 ottobre Imprenditoria femminile Conciliazione fra vita lavorativa e vita familiare Nuove opportunità dal 2014 Bioindustry Park Silvano Fumero Colleretto Giacosa 13 novembre Scienza e Industria Ricerca e innovazione in biomedicina Università Bocconi Milano 27 novembre Donne: insuperabili! Come non subire le scelte, ma farle Confindustria Alessandria Alessandria 28 novembre 2014 XII Congresso Nazionale SSFA I 50 anni di SSFA e la Ricerca in Italia Roma, 31 marzo/1 aprile XXIII Congresso Nazionale GIQAR (GxP) Gestione del cambiamento nelle GxP: Incontro tra industria ed autorità regolatorie Ospedaletto di Pescantina (VR), 18, 19, 20 Giugno Giornata di Studio Operational Excellence: esperienze a confronto Milano, 10 ottobre Page 13/17 - Curriculum vitae of Rita Bussi Signature

14 PAPERS AND POSTERS R. Bussi "Procedure Operative Standard: allestimento e applicazioni", lecture presented at the Società di Scienze Farmacologiche Applicate (GLP Group), 1984 Lamberti L., Ardito G., Bigatti P., Stanyon R., Bussi R. "Satellite associations e fenomeno del chimerismo in Callithrix Jacchus", 3rd National Meeting on Primatology, Torino, 1984 R. Bussi, S. Tofani, S. Ferrini, G. Agnesod, P. Ossola "Effetti sulla gravidanza in ratti esposti a bassi livelli di campi elettromagnetici a MHz". Published on Rivista di Tossicologia Sperimentale e Clinica, Vol. XIV, Fasc. 1-2, 1985 S. Ferrini, R. Bussi, G.P. Berruto "The effects on morphological and neurological development of offspring of dams exposed continuously to very low frequencies" Abstract: Poster showed at the 26th Congress of European Toxicology Society, Finland, 1985 R. Bussi, S. Ferrini, G. Salvi "Effects of Maltitol (Malbit) in a teratogenesis study in New Zealand White rabbits" Poster showed at the 13th Conference of European Teratology Society, East Germany, 1985 R. Bussi, S. Fracchia, G. Oberto "Studio Preliminare degli effetti dell'esposizione prenatale di Medrossiprogesterone Acetato (MPA) nel marmoset" Abstract: Poster showed at the VII National Congress of the Italian Toxicology Society, Bari, 1986 R. Bussi, S. Fracchia "Relevance of historical data in the interpretation of teratogenicity results" Lecture presented at the RBM meetings 2: "Topics in Reproductive Toxicology", Ivrea, 1986 published in 1987 by Istituto di Ricerche Biomediche "A. Marxer" RBM, C.P. 226, Ivrea (Torino) S. Fracchia, R. Bussi "Management of fetus observation data by personal computer" Poster showed at the 15th Conference of European Teratology Society, Switzerland, 1987 Abstract published in Teratology, 36, 1, 1987 S. Fracchia, E. Giavini, C. Volpi and R. Bussi A score as a method in skeletal developmental evaluation Poster showed at the 16th Conference of European Teratology Society, Baveno - Italy Abstract published in Teratology, 38, 2, 1988 Page 14/17 - Curriculum vitae of Rita Bussi Signature

15 G. Peretti, R. Bussi and G. Berruto An information system for reproductive toxicology studies Poster showed at the 18th Conference of European Teratology Society, Edinburgh (UK) Abstract published in Teratology, 42, 2, 1990 R. Bussi, V. Bianchi, E. Giavini, R. Kreiling, G. Malinverno Rabbit teratology study on E-Phthaloyl imido caproic acid (PAC) Poster showed at the 20th Conference of European Teratology Society, Wurzburg (Germany) Abstract published in Teratology, Vol. 46 n.3, Sept R.Bussi Tossicità della riproduzione: Innovatività della "Guideline" Tripartita (CEE, USA, Giappone) Oral presentation at: Giornate di studio - Gruppo Scientifico Italiano Studi e Ricerche: Studi Preclinici, Nuovi Orientamenti Scientifici e Regolatori Milan - Italy - Published on the Abstracts of the meeting R. Bussi, L. Comotto, P. Marinelli, E. Stradella Computer - Assisted Sperm Analysis (CASA) of rodent epididymal after short exposure to Di (2-ethylthexyl) Phthalate (DEPH). Poster showed at the 23rd Conference of European Teratology Society, ETS, Dublin, September 4-7, 1995 Abstract published in Teratology Vol. 51, No. 6, June 1995 R. Bussi Tossicità della riproduzione: Novità dopo ICH 3 Oral presentation at Giornata di Studio: Il processo di armonizzazione delle Normative dopo ICH 3, organized by SSFA, Milan - on Reproductive Toxicology: updating of the Harmonized Tripartite Guideline, April 1996 R. Bussi, G. Chierico, N. Drouot, V. Garuy, S. Hubbard, G. Maliverno, W. Mayr Rat Embryo-fetal Development Study on Sodium Perborate Tetrahydrate. Poster showed at the 24th Conference of European Teratology Society, ETS, Rome, September 2-5, 1996 R. Bussi, C. Ciampolillo, L. Comotto Incidence of spontaneous fetal alterations in Crl: CD-1 (ICR) BR mouse Poster showed at the 24th Conference of the European Teratology Society ETS, Rome September 2-5, Page 15/17 - Curriculum vitae of Rita Bussi Signature

16 R. Bussi, L. Comotto, P. Dossetto Computer-Assisted semen analysis of rodent epididymal sperm motility and count using the Hamilton - Thorne version IVOS10 analyzer: applied methods. Poster showed at the 24th Conference of the European Teratology Society. ETS. Rome September 2-5, 1996 D. Newall, R.Bussi, G. Copping, D. Creasy, J. Edwards, S. Khalil, D. Lewis. T. Palmer, S. Plassmann, J. Tesh, Ulbrich, J. Williams, ETS Male Fertility Working. A critical Re-Appraisal of the Application of ICH Guidelines to Male Fertility Testing Poster presented at the 25th Conference of the European Teratology Society - ETS, Cannes, September R. Bussi, M.T. Draghetti, J. Hunter and M.M. Parkinson Changes of the levels of thyroid hormones during pregnancy in CD- 1 mice Poster presented at the 26 th Conference of the European Teratology Society ETS, Stockholm, September 1998 L. Comotto, P. Dossetto, R. Bussi Validation of CASA system for the analysis of sperm motility and count in the rabbit Poster presented at the 27 th Conference of the European Teratology Society. ETS, Oxford, September 1999 R. Bussi, L. Comotto Incidence of spontaneous fetal alterations in Crl: CD (SD) BR rats, Crl: CD-1 (ICR) BR mice and New Zealand White rabbits Poster presented at the 28 th Conference of the european Teratology Society ETS Ferrara, September 2000 Page 16/17 - Curriculum vitae of Rita Bussi Signature

17 PUBLICATIONS S. Tofani, C. Agnesod, P. Ossola, S. Ferrini and R. Bussi "Effect of continuous low level exposure to radiofrequency radiation on intrauterine development in rats". Published in Health Physics, Vol. 51 No. 4, October 1986, p P.Montaguti, R.Ceserani, R.Bussi, E.Cavalletti and S.Tognella "Reproductive Toxicology of the New Antitussive Moguisteine" Published in Arzneimittel Forschung - Drug Research, 44 (II), 12, G.Coppi, M.A.Amico-Roxas, F.Bertè, R.Bussi, P.Gnemi, R.J. Harling, S.Manzardo, J.E.Massey, D.J.Spencer, Briggs, S.Stovall, E.Vigna, L.A.Waterson "Toxicological evaluation of Pidotimod" Published in Arzeimittel Forschung - Drug Research, 44, (II), 12a, , 1994 R.Maraschin, R.Bussi, A.Conz, L.Orlando, R.Pirovano, A.Nyska "Toxicological evaluation of u-hegf" Toxicologic Pathology, 23 (3), May-June 1995 R. Maraschin, R. Bussi, A. Conz, L. Orlando, R. Pirovano, A. Nyska Toxicological evaluation of u-hegf (human epidermal growth factor) Toxicologic Pathology, Vol 23, No. 3, 1995 pp R. Bussi, C. Ciampolillo, L. Comotto, R. Maraschin and S. Komatsu Reproductive and Developmental Toxicity Studies of SJ-0021 (rhfsh) Japanese Pharmacology and Therapeutics, Vol. 23 No. 8, 1995 PATENTS N.A. PROFESSIONAL AFFILIATIONS and MEMBERSHIPS 1996 Member of National Order of Biologists European Teratology Society (Council member reelected in 2000) 1988 for other 2 years; reelected in European Society of Toxicology Società di Scienze Farmacologiche Applicate Page 17/17 - Curriculum vitae of Rita Bussi Signature

18 RBM INSTITUTIONAL COURSES (GXP, LACS, Health & Safety) 2004 Course on Legge 626: Igiene e sicurezza sul lavoro 05/2005 Advanced GLP course on Illustrazione delle varie tipologie di documenti, del processo di gestione del cambiamento e delle deviazioni. Illustrazione del ruolo e delle responsabilità delle varie funzioni nel processo di qualifica. 10/2005 GMP course on Approfondimento di argomenti tratti dalle normative e dai documenti interpretativi 03/2006 Course on Sicurezza sul luogo di lavoro per personale del laboratorio by RBM Head of EHS, Maintenance & General Services. 05/2006 Course on SQS 24/01 Non-clinical GLP study management by RBM QA 05/2006 Course on Utilizzo di Crystal by RBM QA 06/2006 Course on Interpretazione della legge anticorruzione (FCPA) by LRN 08/2006 Trackwise training by RBM QA 10/2006 Course on Protezione delle informazioni by LRN 10/2006 Course on Serono Codice di condotta internazionale by LRN 02/2007 GxP docs training by RBM QA 03/2007 Course on Legge sulla Privacy by LRN 04/2007 Course on Sicurezza sul luogo di lavoro per dirigenti e preposti by Team Consulting 12/2007 Utilizzo IT Self Service di Corporate 04/2008 Gestione degli studi multisito 09/2008 Corso Sicurezza sul Lavoro. Testo Unico sulla Sicurezza D. Lgs. 81/08 nuova normativa: novità e cambiamenti 03/2009 Sorveglianza Sanitaria Lavoratrici Madri Corso sul rischio biologico 31/03/09 Page 18/17 - Curriculum vitae of Rita Bussi Signature

19 10/2009 Corso sul rischio da radiazione ottiche artificiali La gestione dei rifiuti 03/2011 Orientamenti generali per il ricevimento delle ispezioni GxP da parte degli Enti Regolatori. Page 19/17 - Curriculum vitae of Rita Bussi Signature