Secretary of the National Pharmacovigilance Committee. Deputy Head of Adverse Drug Reactions Dept

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1 Curriculum vitae PERSONAL INFORMATION Agni Kapou WORK EXPERIENCE November 2011 March 2017 January 2017 August 2018 August 2015 Present May 2015 February 2016 March 2014 January 2017 Secretarial and scientific management of the National Pharmacovigilance Committee monthly meetings. Deputy Head of Adverse Drug Reactions Dept PV team management Legal issues of new employees in basic pharmacovigilance activities Evaluation of DHPCs Signal management PSUR assessment RMP Assessment PV promotion Deputy Responsible for Quality Assurance of the Division of Pharmaceutical Studies & Research Maintenance of the Quality System of the Devision of the employees of the Devision Deputy Head of Adverse Drug Reactions Dept Preliminary and final evaluation of the incoming ADR reports Submission of ADR reports to EUDRAVIGILANCE Follow-Up communication with HCPs Evaluation of DHPCs and Educational Material (RMP) RMP Assessment of new employees on basic pharmacovigilance activities Deputy Head of National Formulary Dept Design and development of a new National Formulary 26/9/18 European Union, Page 1 / 5

2 October 2011 January 2017 April 2001 October 2011 January 2001 July 2001 Pharmacovigilance officer in the Adverse Drug Reaction Dept Preliminary and final evaluation of the incoming ADR reports Submission of ADR reports to EUDRAVIGILANCE Follow-Up communication with HCPs Evaluation of DHPCs and Educational Material (RMP) Government controller Ministry of Health - Public Health Insurance Organizations (OPAD-TYDKY, OAEE) (Greece) Control of good practice in prescribing and dispensing medicines and of pharmaceutical expenditure - Inspections in pharmacies (as private enterprises) or in clinics and hospitals Researcher in the Laboratory of Molecular Analysis in NHRF Ministry of Education - University of Ioannina and National Hellenic Research Foundation (NHRF) (Greece) Study of the molecular structure of NSAIDs (Oxicams) by NMR spectroscopy EDUCATION AND TRAINING March 2001 July 2007 September 1999 March 2001 July 1999 July 1999 September 1994 July 1999 PhD in Medicinal Chemistry (Drug Design) University of Patras (Departments of Pharmacy and Chemistry) - National Hellenic Research Foundation (Greece) Drug Design NMR spectroscopy Differential Scanning Calorimetry (DSC) Molecular Modeling 3D-Quantitative Structure Activity Relationships (3D-QSAR) Msc in Medicinal Chemistry (Conformational Analysis) University of Patras (Departments of Pharmacy and Chemistry) - National Hellenic Research Foundation (Greece) Synthesis NMR spectroscopy Molecular Modeling Professional license Ministry of Health (Greece) License for working as a pharmacist in Greece Degree in Pharmacy University of Athens - Department of Pharmacy (Greece) April 2012 April 2012 EUDRAVIGILANCE certificate 26/9/18 European Union, Page 2 / 5

3 EUDRAVIGILANCE use May 2013 May 2013 November 2013 November 2013 January 2014 January 2014 October 2014 October 2014 November 2015 November 2015 December 2015 December 2015 October 2016 October 2016 October 2016 October 2016 September 2016 September 2016 November 2016 November 2016 XEVMPD certificate Extended EV Medicinal Product Dictionary (XEVMPD) use PhV Inspectors EV and EVDAS EV and EVDAS use Assessor's training PSURs, Referrals, RMPs and Post Authorization studies assessment: Increase knowledge of what were the major scientific, regulatory and procedural updates in the last year and gain awareness trough discussion of relevant examples trough the lifecycle of the product. Signal Detection Workshop Current state of the art in terms of the science of signal detection, proposals for evidence based process improvements and to identification and discussion of current and future challenges. - BfArM EVDAS training for NCAs Signal detection and signal management PhV assessment (in scope WP8) Scope Joint Action (Portugal) RMP, PSUR, PASS assessment etc. Pharmacovigilance assessments challenges and solutions for pharmacovigilance assessors 26/9/18 European Union, Page 3 / 5

4 (United Kingdom) Share the experience in different procedures concerning a pharmacovigilance assessment, to identify best practice. December 2016 December 2016 Introduction to the Basics of Clinical Research National Organization for Medicines (EOF)-Clinical Trials Dept (Greece) CT Protocols approval procedures and CT Inspections. April 2017 April 2017 Pharmacovigilance training course 2017 (United Kingdom) RMP, PSUR, PASS assessment, Signal Management etc. April 2017 April 2017 Signal management additional training (in scope WP5) Scope Joint Action (Netherlands) Concepts of signal management process applied at member state level (Signal detection, prioritazation, validation, confirmation, etc.), focus on reports of special interest and practical exercises. October 2017 October 2017 EVDAS training (United Kingdom) Train the trainers in EVDAS (changes due to new Eudravigilance). November 2017 November 2017 Pharmacovigilance assessments (United Kingdom) Pharmacovigilance assessments challenges and solutions for pharmacovigilance assessors December 2017 December 2017 The NEW EudraVigilance System DIA () (Greece) The NEW EudraVigilance System and the electronic reporting of ICSRs in the ISO/ICH E2B(R3) format. January 2018 January 2018 NEW UNNIFIED QUALITY SYSTEM in EOF National Organization for Medicines (Greece) New SOPs. April 2018 April 2018 MedDRA coding MSSO (Greece) Coding with MedDRA, MedDRA: Safety Data Analysis and SMQs ADDITIONAL INFORMATION Expertise Risk Management & Risk Communication Management and assessment of ADR reports Drug Design (Conformational Analysis, NMR Spectroscopy, 3D QSAR) Good practice in prescribing and dispensing medicines Publications International Journals 26/9/18 European Union, Page 4 / 5

5 Kapou A., Fousteris M., Nikolaropoulos S., Zervou M, Grdadolnik S., Zoumpoulakis P., Kyrikou I., Mavromoustakos T., 2D NMR and conformational analysis of a prototype anti-tumour steroidal ester, J. Pharm. Biomed. Analysis, (2005), 38, Kapou A., Nikolaropoulos S., Siapi E. and Mavromoustakos T., Effects of steroidal carriers of alkylating agents on the phase transition in DPPC membrane bilayers, Thermochimica Acta, (2005),429, Kapou Α., Benetis Ν., Avlonitis Ν., Calogeropoulou Τ., Koufaki Μ., Scoulica Ε., Nikolaropoulos S., Mavromoustakos T., 3D-Quantitative Structure-Activity Relationships of Synthetic Antileishmanial Ring-Substituted Ether Phospholipids, Bioorg. Med. Chem., (2007) 15(3), Durdagi S., Kapou A., Kourouli T., Andreou T., Nikas SP., Nahmias VR., Papahatjis DP., Papadopoulos MG., Mavromoustakos T., The application of 3D-QSAR studies for novel cannabinoid ligands substituted at the C1 position of the alkyl side chain on the structural requirements for binding to cannabinoid receptors CB1 and CB2, J. Med Chem. (2007) 50(12), Durdagi S., Koukoulitsa C., Kapou A., Kourouli T., Andreou T., Nikas S. P., Nahmias V. R. Papahatjis D. P., Testing the 3D-QSAR/CoMFA-CoMSIA results of flexible bioactive compounds with molecular docking studies, Drugs of the Future (2007) 32, Kapou A., Benetis N.P., Durdagi S., Nikolaropoulos S., Mavromoustakos T., 3D QSAR/ CoMFA and CoMSIA studies on antileukeumic steroidal esters coupled with conformatioanally flexible nitrogen mustards, J. Chem. Inf. Mod. (2008), 48(11), Publications in Books and Electronic Journals Kapou A., Mavromoustakos T., Grdadolnik S. G.,Nikolaropoulos S., Synthesis and Conformational Analysis of Steroidal Carriers of Alkylating Agents with the Use of Two-Dimensional Nuclear Magnetic Resonance in Drug Discovery and Design: Medical Aspects, Part III (J. Matsoukas and T. Mavromoustakos, Eds), IOS Press, (2002), Mavromoustakos T., Kyrikou I., Kapou A., Kovala Demertzi D., Effects of NSAIDs in Membrane Bilayers in Drug Discovery and Design: Medical Aspects, Part II (J. Matsoukas and T. Mavromoustakos, Eds), IOS Press, (2002), Mavromoustakos Τ., Zoumpoulakis P., Zervou M., Kyrikou I., Kapou A., Benetis N., The Use of Computational Analysis to Design Novel Drugs, Proceedings of the International conference of Computational Methods in Science and Engineering (2003), ed. T.E.Simos, p Mavromoustakos T., Kapou A., Benetis N.P., Zervou M., Conformational Analysis using 2D NMR Spectroscopy Coupled with Computational Analysis as an Aid in the Alignment Procedure of 3DQSAR Studies, Drug Des. Rev. - Online, (2004), 3, E. Apostolidou, G. Aislaitner, L. Klironomos, A. Kapou, D. Kouvelas. The Impact of the New Pharmacovigilance Legislation on the Applications and Files Submitted To the Department of Adverse Drug Reactions of the National Organisation for Medicines in Greece (EOF), Poster presentation in the 31st International Conference on Pharmacoepidemiology & Therapeutic Risk Management (2015) Projects Memberships Alternate member in the PhV Inspectors Working Group () Member in PRAC Other Relevant Information 26/9/18 European Union, Page 5 / 5