Pharmacovigilance assessor. National Institute of Pharmacy and Nutrition (OGYÉI) (Hungary) Senior hospital Pharmacist

Transcription

1 Curriculum vitae PERSONAL INFORMATION Gyorgyi Fodor WORK EXPERIENCE September 2011 Present Pharmacovigilance assessor National Institute of Pharmacy and Nutrition (OGYÉI) (Hungary) Benefit/risk assessment, periodic safety update reports' (PSURs/PRBERs) assessment as lead Member State assessor in the frame of the European Single Assessment (PSUSA) procedures. Signal detection, management. Risk management plans (RMPs) assessment pre- and postmarketing Responsible for assessing and approving Risk Minimisation Measures (RMMs) such as Educational materials prepared by marketing authorisation holders (MAH) and quality control of the PV assessment within the NCA. Review of safety journals, clinical trials, epidemiological studies, and related literature. Quality control of the causality assessment and reporting of ICSRs via the EudraVigilance system to the European Medicines Agency (EMA) Quality control of the ICSR reports sent by MAHs in Hungary. Hungarian delegate and active contributor to the work of the Pharmacovigilance WorkSharing Procedures Working Party (CmDh). Postgraduate educator/lecturer: pharmacovigilance post-graduate curriculum in collaboration with the Semmelweis Medical University of Budapest. Active contributor, author and lecturer in the SCOPE project Work Package 7 Quality management systems in Pharmacovigilance in special topic of Stakeholder feedback and customer satisfaction; active contributor to the work of the WP4 ADR reporting topic as well ( ) - lectures available at the EMA EU Network Training Centre May 2009 June 2011 Acting Chief Pharmacist - Supervising and superintendent pharmacist HSE - St Brendan s Hospital Dublin - Pharmacy Department (Ireland) Responsible for overall professional policy and clinical management of pharmacy practice and administration of sale and supply of drugs, control of pharmacy. Dispensing drugs and controlled drugs to wards of two hospitals, St. Brendan s and St. Ita s psychiatric hospitals, to hostels (patient residential homes) and to out-patients clinics (530 patients in total). Develop and expand ward clinical pharmacy service. Ensuring effective, economical stock control at pharmacy and ward level, record keeping complying with legislation practice guidelines and Health Services Executives standards. Developing and maintaining up-to-date policies governing the pharmacy; ensuring safe working practices are adhered to and quality control of services maintained. Managing staff within the department, collaborate with nursing, medical staff at ward and management level. Ensuring that highest professional, clinical standards are maintained at all times complying with the Pharmacy Act, 2007; ensuring that best practice and Evidence-based guidelines are followed. Drug chart screening and assessment; intervene clinically when deemed to be necessary. Developing and extending the pharmacy service (premises, staff, services) across three individual hospitals psychiatric hospitals and care of elderly patients. Active member of Drugs and Therapeutics Committee and Medication Management work groups developing and updating prescription chart, prescribing guidelines, medication management policies. February 2006 May 2009 Senior hospital Pharmacist HSE - St Brendan s Hospital Dublin - Pharmacy Department (Ireland) 17/10/17 European Union, Page 1 / 7

2 Supplying drugs to the wards of St. Brendan's and St. Ita's Hospital complying with best practice guidelines and legislation. Dispensing Clozaril to outpatients and inpatients, ensuring protocols are followed. Provision of advice to other health care professionals as required for the appropriate and economical use of drugs. Screening kardexes, making interventions to ensure patient safety and safe prescribing. Consulting with other healthcare professionals about medication management. Training new staff; supervision of assigned technicians and pharmacist. Procurement of drugs, ensuring the most optimal stock level. Printing and filing daily audit reports and other requested reports. Dispensing Controlled drugs, and maintaining records. April 2003 February 2006 Senior hospital pharmacist Uzsoki Street General Hospital, Budapest (Hungary) Dispensing drugs to the inpatient wards and outpatients in retail pharmacy settings. Pricing, ordering, invoicing and stock control. Ensuring that the pharmacy operates within the agreed hospital budget. Ensuring the wards operate within the allocated medical expences. Providing reports on medication usage. Dispensing and maintaining record of MDA drugs. Drug compounding (aseptic compounding as well). Provision of information about medicines for patients and healthcare professionals. Control of supply of high-technology oncology drugs. Supervision and training of technicians and assigned staff. Developing and piloting unit dose drug delivery systems. Controlling and managing on-going clinical trials. January 2001 March 2003 CNS Product Manager (psychiatry and neurology) Janssen-Cilag, division of Johnson & Johnson Ltd (Hungary) Increasing the market share and sales of a 7 year old product (psychiatry), launch of new indications and life cycle management. Launching to the market a new antiepileptic product. Organising symposia on national and international conferences. Yearly budget planning and allocating. Presenting lectures and articles release (on International Product Manager s meetings). Building and maintaining professional relationships with specialist lecturers. Producing evidence-based professional promotional materials Training and motivating the sales representatives. Preparing and presenting short- and mid-term Business Plan to the Board and ensuring its execution. Forecasting sales and required production. Being a member of the European Commercial Team, active involvement of implementation and creation of international strategies International Product Manager for antibiotics Chemical Works of Gedeon Richter Ltd (Hungary) Launching new products into the Hungarian and Central-European markets. 17/10/17 European Union, Page 2 / 7

3 Product life-cycle management. Preparation of marketing and business plans; short and midterm planning, forecasting. Leasing with licence partners. Planning short- mid- and long-term competitive product strategies, presenting business plans. Developing promotional campaign, promotional materials. Managing allocated budget. Organising symposia on national and international congresses. Training and motivating medical representatives; preparing presentations and holding lectures. Building and maintaining good relationship with specialist lecturers. Increasing the sales of the product with evidence based promotional materials and other business strategies International market analyst and licensing in executive Chemical Works of Gedeon Richter Ltd. - Strategic marketing department (Hungary) Preparing market research studies covering 10 countries worldwide based on medical and market trends (using IMS-International Medical Statistics and other data). Preparing proposals for future research and development of new products and active ingredients. Identify potential products for licensing-in. Analysing market potential of new products before the launching it. Dealing with the settlement of licence negotiations and agreements. Participating on business talks and delivering business correspondences with national and international partners Basic Grade Hospital Pharmacist Uzsoki Street General Hospital, Budapest (Hungary) Dispensing drugs to the wards. Dispensing and maintaining record of MDA drugs. Drug compounding including aseptic compounding. Provision of medicine information for patients and healthcare professionals. Supervising and training technicians and assigned staff member. EDUCATION AND TRAINING October 2017 October 2017 EVDAS 'train-the-trainer' training on new functionalities (ISO / ICH E2B(R3) European Medicines Agency (EU NTC) (United Kingdom) September 2017 September 2017 EudraVigilance User training ISO / ICH E2B(R3) European Medicines Agency (EMA) (United Kingdom) November 2016 November 2016 PRAC pharmacovigilance assessor training European Medicines Agency (United Kingdom) October 2016 October 2016 Active contributor, author and lecturer SCOPE Work Package 7 Quality Management Systems in Pharmacovigilance and WP5 Signal Management - training course (Hungary) Quality Management in Pharmacovigilance, Signal Management 17/10/17 European Union, Page 3 / 7

4 October 2016 October 2016 Active contributor and participant SCOPE Work Package 4 ADR Reporting training course (United Kingdom) The main objective of the workshop was to learn from the SCOPE research conducted on how to develop ADR reporting systems. This included topics on raising awareness levels, collaboration with patient organisations, reporting tools, additional monitoring, medication errors, IT systems, quality of reports, duplicate detection and some topics from quality management systems from Work Package 7 of SCOPE. September 2016 September 2016 Participation SCOPE Work Package 8 Lifecycle Pharmacovigilance - training course (Portugal) SCOPE is developing recommendations, guidance and training for regulators to support the EU pharmacovigilance network Work Package 8 aims to explore existing standards for pharmacovigilance assessments and a good practices useful to ensure that National Competent Authorities (NCAs) are able to support the Pharmacovigilance Risk Assessment Committee (PRAC) with high-quality assessment and advice on: risk management plans; post authorisation studies, periodic safety update reports and referral procedures. December 2015 December 2015 delegate EMA Signal detection workshop (United Kingdom) November 2015 November 2015 delegate PRAC assessor training (United Kingdom) October 2014 October 2014 Pharmacovigilance assessor training EMA London (United Kingdom) pharmacovigilance (signal detection, PSUR/PSUSA, RMP, PASS...) October 2014 October 2014 Public administration Specialist (higher) examination National University of Public Service Faculty of Public Administration Budapest (Hungary) public administration September 2011 July 2013 Professional English and Hungarian Translator and Interpreter in Health Sciences Medical University of Szeged (Hungary) English/Hungarian medical translations English/Hungarian interpreter March 2013 March 2013 Licensure for ICSR reporting to the EudraVigilance database European Medicines Agency (United Kingdom) EudraVigilance-electronic reporting of ICSRs - EMA training course November 2012 November 2012 MedDRA user MedDRA MSSO (United Kingdom) Coding with MedDRA and MedDRA Safety Data Analysis and SMQs training course 17/10/17 European Union, Page 4 / 7

5 March 2012 March 2012 Public Administration (Hungary) Public Administration basic level state exam February 2012 February 2012 EVDAS user European Medicines Agency (United Kingdom) EV Data Analysis System (EVDAS) Training for National Competent Authorities EMA November 2010 November 2010 Superintendent pharmacist Pharmaceutical Society of Ireland, Irish Centre for Continuing Pharmaceutical Education ICCPE (Ireland) PSI/ICCPE training course for Superintendent Pharmacists November 2010 November 2010 clinical skills HPAI (Hospital Pharmacist Association) (Ireland) Clinical Skills Course Part-II, HPAI Clinical pharmacy training course (2 days) November 2009 November 2009 clinical skills HPAI (Hospital Pharmacist Association) (Ireland) Clinical Skills Course Part-III, HPAI (Hospital Pharmacist Association) Clinical pharmacy training course (2 days) October 2009 October 2009 manager Health Services Executive (HSE) (Ireland) People Management, The legal framework HSE training course September 2008 October 2009 Master of Sciences in Clinical Pharmacy University College Cork and Centre for Advanced Clinical Therapeutics, St. James s Hospital, Dublin (Ireland) Clinical pharmacy, hospital pharmacy, pharmacology, pharmacotherapy, biostatistics, critical appraisal PSI Tutor Pharmacist course Pharmaceutical Society of Ireland (Ireland) Tutor pharmacist in Ireland Specialist Pharmacist in Clinical Pharmacy National Examination Board of Pharmacy (Hungary) October 2002 October 2002 sales management Con Action (United Kingdom) Sales management international training course August 2002 August 2002 lecturer Con Action (United Kingdom) Lecture technique training 17/10/17 European Union, Page 5 / 7

6 May 2001 May 2001 negotiations (Hungary) Negotiation Skills training February 2001 February 2001 marketing master class JS Training (United Kingdom) Practical Training Expertise: Marketing Master Class training Specialist Pharmacist in Clinical Pharmacology National Examination Board of Pharmacy (Hungary) September 1998 September 1998 product management (United Kingdom) Complete Healthcare Training, Practical and Effective Product Management July 1998 July 1998 forcasting (United Kingdom) Complete Healthcare Training, Forecasting Training course June 1997 June 1997 marketing strategies MarkStrat Pharm (United Kingdom) Dynamic Marketing Strategies training September 1994 July 1996 Qualified economist for foreign trade Business College of Foreign Trade, Budapest (Hungary) Economist, marketing specialist May 1995 May 1995 health economic (United Kingdom) Complete Healthcare and Health Economic Training course September 1988 July 1994 Master of Pharmacy degree Semmelweis Medical University, Faculty of Pharmacy (Hungary) Pharmacist ADDITIONAL INFORMATION Expertise -pharmacovigilance (assessment of PSUR/PSUSA, RMP, PASS, ICSR reporting, quality control, educatioinal materials, signal detection) -clinical pharmacy -hospital pharmacy -medication safety at hospital level -medication errors 17/10/17 European Union, Page 6 / 7

7 -CNS -Antiinfectives -pharmacy management, pharma industry - management and marketing Publications Strengthening Collaboration for Operating Pharmacovigilance in Europe (SCOPE) Joint Action Work Package 7 Quality Management Systems: Stakeholder Feedback and Customer Satisfaction (2016) lecture, guidance document and interactive PDF teaching tool published at Projects SCOPE Project Work Package4 and Work Package active participant and author: MSc in Clinical Pharmacy Thesis research: Detailed audit of inpatient prescription writing at St. Brendan's Psychiatric Hospital Dublin, 2009 Clinical Pharmacy Diploma Thesis: The role of the clinical pharmacist in the care of patients with chronic renal failure Budapest, 2005 Pharmacology Diploma Thesis: Pharmacokinetics and pharmacodynamics of the penicillin antibiotics Budapest, 1999 Economist Diploma Thesis: Strategic marketing product management of a drug company. Budapest, 1996 Pharmacy Diploma Thesis: Application of recombinant gene technology in the production of drugs and vaccines. Budapest, 1994 Memberships Registered licensed pharmacist - Pharmaceutical Society of Ireland since registration cancelled in 2013 Registered licensed pharmacist - Hungarian Chamber of Pharmacists since ongoing Hospital Pharmacists Association of Ireland - HPAI United Kingdom Psychiatric Pharmacy Group - UKPPG Irish Psychiatric Pharmacist Group IPPG European Society for Clinical Pharmacy - ESCP Other Relevant Information 17/10/17 European Union, Page 7 / 7