Curriculum Vitae
PERSONAL INFORMATION
Anna Ivanova
WORK EXPERIENCE
September 2010–Present
Chief Expert
Bulgarian Drug Agency, (Bulgaria)
Evaluation of educational programmes, physician educational materials, patient information packs,
DHPCs, etc.
Management of suspected adverse drug reaction reports (ICSRs) incl. ADR evaluation and
processing to EudraVigilance.
Signal management activities.
Preparation of public information (press releases) with regard to pharmacovigilance.
Others.
Related document(s):
October 2005–August 2006
Regulatory Affairs Assistant /Officer
Novo Nordisk Pharma EAD-Bulgaria, (Bulgaria)
Handling of all Regulatory Affairs activities e.g preparation of local drug dossiers for submission;
translation of SPC, Patient inserts, Labeling from English to Bulgarian language; proofreading of local
labeling and inserts; approval of promotional materials; preparation of price; reimbursement; Positive
Drug List and tender applications; Reporting of Spontaneous Adverse Events; Acting as co-auditor
during quality audits
Related document(s):
February 2003–September 2005
Regulatory &Quality Assistant (Quality Assistant 05 Feb 2003 – 31 Mar 2005))
Novo Nordisk Representative Office, (Bulgaria)
Handling of all Regulatory Affairs activities e.g preparation of local drug dossiers for submission;
translation of SPC, Patient inserts, Labeling from English to Bulgarian language; proofreading of local
labeling and inserts; approval of promotional materials; preparation of price; reimbursement; Positive
Drug List and tender applications; Reporting of Spontaneous Adverse Events
Handling of Quality Activities; Assisting General Manager with relation to maintaining Quality
Management System: preparation and approval of SOPs; QMR;QAP; Customer complains; Adverse
events; Lead Auditor at internal and external Audits; validation of fridges for storage of samples
Related document(s):
December 1999–February 2003
Chief Expert at Regulatory and expert function at Department “Marketing
Authorization”
Bulgarian Drug Agency, (Bulgaria)
Check of information on Marketing Authorizations; preparation of Marketing Authorizations;
Maintaining Data Base with Marketing Authorizations; Handling of register of MA; preparation of
reports regarding MA status of drugs; post-marketing inspector
Related document(s):
September 1994–November 1999
Inspector at Regulatory, expert and inspection functions at Directorate ”Control of
wholesaling and Retailing”
Bulgarian Drug Agency, (Bulgaria)
Assessment of applications for wholesaler licences; Participation at expert committee for proposing of
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Curriculum Vitae
Anna Ivanova
wholesaler licences; preparation of Wholesaler licences; Maintaining Data Base and register for
wholesalers licences; Inspection of wholesalers and pharmacies; expert opinions on local regulations
Related document(s):
EDUCATION AND TRAINING
May 2012–Present
Certificate of Proficiency in Data Analysis - EVDAS User
DIA, European Medicines Agency, (United Kingdom)
Related document(s):
April 2011–Present
certificate of of Proficiency in E-reporting of ICSRs-EudraVigilance
User Training Course
DIA, European Medicines Agency, (United Kingdom)
Related document(s):
May 2006–Present
Course – Мodule 1 “The Pharmaceutical Law Frames in the EU”
School Medacademy (A Diploma and Qualifying Education; established by Danish Association of the
pharmaceutical industry(LIF)) , (Denmark)
Related document(s):
August 2004–August 2005
Certifiate of Pharmacoeconomics ISPOR Distant learning course –
1 year
ISPOR (International Society for Pharmacoeconomics &Otcomes Research), (Bulgaria)
Related document(s):
May 2003–Present
Lead Auditor and GDP inspections, IQS Lead Auditor and GDP
Training Course;IQS Quality Training Course
Novo NordiskA/S, (Denmark)
covers competencies of Lead auditor; performing an audit; GDP principles and requirements;
Certificate for performing Quality activities e.g. validation of cold rooms; approving of calibration
certificates; audits; customer complaints
Related document(s):
April 2003–
Certificates for Internal Quality Auditor; planning; performing and
reporting of audits;Lloyd’s course for Internal Quality Auditor
LRQA (Lloyd’s Register Quality Assuarance Limitted- professional auditing organization), (Bulgaria)
Related document(s):
March 2003–Present
Certificate for Quality Systems Manager competencies;
qualifications; Lloyd’s course for New Quality Systems Manager
LRQA (Lloyd’s Register Quality Assuarance Limitted- professional auditing organization), (Bulgaria)
Related document(s):
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Curriculum Vitae
March 2003–Present
Anna Ivanova
Certificates for knowledge for ISO 9001:2000 requirements and
principles
LRQA (Lloyd’s Register Quality Assuarance Limitted- professional auditing organization), (Bulgaria)
Related document(s):
September 2001–Present
Certificates from Course
Mediterranean School of Epidemiology and Statistical Methods in Biomedical Research, (Italy)
statistical methods; statistical computer program Stata ;Cost-effectiveness analysis in health care;
performing of Cost-effectiveness analysis
Related document(s):
January 1999–December 2002
Diploma for Specialist on “Pharmaceutical marketing and economy”
Faculty of Pharmacy, Medical University, Sofia, , (Bulgaria)
Related document(s):
September 1989–June 1994
Diploma on Master of Pharmacy degree
Faculty of Pharmacy, Medical University, Sofia, , (Bulgaria)
Related document(s):
ADDITIONAL INFORMATION
Expertise
• Risk identification and communication
• ICSRs management
• Evaluation of educational materials
•Pharmacoeconomic evaluation
Publications
Extract of List of publications:
І. Publications in Bulgarian scientific literature
1. Иванова А., С. Даскалова, И. Гетов, Г. Петрова, Фармакоикономическа оценка на структурата
на разходите за лечение на две урологични заболявания-Част ІІ (Pharmacoeconomic analysis of
cost structure of treatment of 2 urological diseases-Part ІІ) , Социална медицина, 2002, (Х), 2, 37-39
2. Иванова А. Д., Г.И. Петрова. Фармакоикономическа оценка на стойността и последиците при
употребата на серотонинови 5НТ3- рецепторни антагонисти в онкологията (Pharmacoeconomic
analysis of cost and consequences of use of serotonin 5SG3 receptor antagonists in oncology),
Онкологос, 2003, 4: 29-37
3. Иванова А., Г. Петрова.Анализ разход-ефективност при пациенти с артериална хипертония и
сърдечно-съдови усложнения, лекувани с perindopril. (Cost-effectiveness analysis for patients with
arterial hypertension and cardio-vascular complications treated with perindopril) Фармация, 2005; 12: 193-199
ІІ. Publications in foreign scientific literature
5. Dimitrova Zl., I. Getov, A. Ivanova, G. Petrova. Trends in antidiabetic drugs consumption in Bulgaria.
JSAP vol.14, N1, 1997: 52-56
6. Petrova G., A. Ivanova, T. Benisheva, Pharmacoeconomics and the new Bulgarian positive list, The
regulatory Affair Journal Pharma, 2005, Mar; vol. 16 №3, 175-178
7. Petrova GI., Ivanova AD., Petkova VB. Education of patients with diabetes in the community
pharmacies. ARS Pharmaceutica., 2006, submitted for publication
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Curriculum Vitae
Anna Ivanova
ІІІ. Published full texts participation at scientific congresses
8. Petrova G. I., Benisheva TB., Ivanova AD. Pharmacoeonomics introduction in the creation of
positive drug list in Bulgaria, ISPOR Seven Annual European Congress Hamburg, Germany, Sunday,
October 24, 2004. Value in Health, Vol. 7, No. 6 (November/December 2004)
9. Ivanova D A1, Ignatova S R2, Popov V V1, Petrova I G., Analysis of the cost of diabetes treatment
in Bulgaria, ISPOR 8th European Congress. Florence, Italy, Sunday, November 06, 2005, Value in
Health, Vol. 8, No.6 (November/December 2005)
11. Ivanova A., G. Petrova. Cost-effectiveness and quality of life analysis of oncology patients treated
with erythropoietin. 11th panhellenic pharmaceutical congress. Eur. J. Drug Metabol. Pharmacokinet.,
(28) 2003; 80
10. Goranova K., A. Ivanova, M. Goranova, G. Petrova. Pharmacoeconomic analysis of the costs and
health results of 5FU/LEV treatment of patients with colorectal carcinoma. 12th panhellenic
pharmaceutical congress. Eur. J. Drug Metabol. Pharmacokinet., (30) 2005; 28-29
ІV. Моnographs
11. Петрова Г., Т. Бенишева, И. Гетов, А. Иванова, Д. Герасимова. Приложение на
фармакоикономиката в лекарствената регулация (Application of Pharmacoeconomy in drug
regulation), Инфофарма, С. 2004, 100 стр.
Projects
Memberships
SCOPE- 3 year Joint Action project 2013, started 01 november 2013
Safety Working Party, since 2010; TIG - Telematic Implementation Group (2012 – 2013) at EMA
External expert on pharmacoeconomic evaluations at Rrice&Reimbursement Committee to Ministry of
Health (2012- )
Other Relevant Information
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