31.03.
2017
COSMETOVIGILANCE - REGULATION (EU) 1223
FREE FOR BADI MEMBERS 2017
Dr. Peter Psarologos - Drug Safety Physician
Peter Psarologos graduated the Medicine, Novi Sad University,
Serbia.
The Principles of Protein Structure (attendance) - Birbeck College
- London University London, UK.Master in Health Economics,
Policy and Management - University Of Oslo, Norway. He has
worked as a Medical Doctors’ Assistant – Numerous Hospitals in
Europe; as a Medical Research Assistant- Dept. Of Hygiene Medical
Faculty, Novi Sad University; as a Media Analyst – Report International, UK.In 2010
he started worked as Drug Safety Physician of The Norwegian office of Lindeq, since
2016 in PharmaLex Norway. He has experience to activities of pharmacovigilance and
Cosmetovigilance shown below: Practical pharmacovigilance; Pharmacovigilance
management; Establishing and maintaining PV systems; Risk Management (RMP);
Signal Detection; Electronic reporting (certificate EudraVigilance).Project management
; MedDRA; Document Quality management PV; PV Databases (ArisG-BaseCon(SBI));
Cosmetovigilance management
Dr. Vili Topalova, MD is Medical Director of PharmaLex
Bulgaria. Vili Topalova graduated the Medical University, Sofia
as medical doctor. She has worked as a physician, as a neurologist
at the Military Medical Academy for 22 years. Vili Topalova
joined the pharmaceutical industry in 2003. Her first appointment
was for the position medical representative of Inbiotech. Three
years later she has started working in the BDA, first as senior
expert in Department "Marketing Authorization of medicinal
products“, and that as Head of the same Department. As an expert
on Pharmacovigilance she has worked in PharmAdvice.In 2013 she started worked as
Medical director of the Bulgarian office of PharmaLex.She has experience to activities
of pharmacovigilance shown below:Practical pharmacovigilance,Pharmacovigilance
management,Establishing and maintaining PV systems, Audits and participating /
preparation for inspections,Risk Management, Signal detection,Medical
review,Validation of PV databases and data migration,Electronic reporting (certificate
EudraVigilance),Project management, MedDRA, PSMF ,Medical Device,
Vigilance,Cosmetovigilance ,SOPs
Emiliana Stavreva - Master Degree of Pharmacy and Health
Management Medical, regulatory affairs and vigilance manager at
Pierre Fabre Bulgaria. Member of the Bulgarian Pharmaceutical
Union, BADI, BNAEOPC.Works in cosmetovigilance and
regulation of cosmetic products, since 2013.
Prof. Tatyana Benisheva-Dimitrova, DSc., President of BADI
is a professor in the Faculty of Public Health at the Medical
University, Sofia. After receiving an ЕС-CADREAC
scholarship she completed master’s degree in Drug Regulatory
Affairs (2004/2005) at the University of Bonn and later in 2010 a
Masterdegree in “Public Health” at the Medical University of
Sofia. She was a Director of the “Drug Policy” Directorate in the
Ministry of Health (2000-2005) and has over 10 years of
experience, at the “Bulgarian Drug Agency (BDA). As the first
president of the National Council on Prices and Reimbursement of Medicinal Products
2013-2014 she started an EU-project-OPAC (0.7Mln BGN) for establishing of
electronic database of MPs. President of the Bulgarian Association of Drug Information
since 2010 - 2013. Member of BACR and DIA (2010-2014). Since May 2015 she has
been a President of BADI. Managing director of consulting in Bulgaria Betaconsult
Pharma Ltd 2007-2013. Her 25 years of experience in drug regulatory affairs in
marketing authorization, pricing reimbursement and outcome research and later HTA is
complemented by more than 75 publications on pharmaceutical regulations. Consultant
activities at the global regulatory database IDRAC of the Thompson Reuters 2006-2012
and consultant to the project of the European Commission - PLAC assignment medicinal
product pricing since 2.
 Prof. Karolina Lyubomirova, MD, PhD, MPH, ERT
Is a professor in the Faculty of Public Health at the Medical
University Sofia, vice dean on international cooperation and
projects. After graduation in Medical University Sofia she
defended PhD thesis in toxicological risk assessment. The results
achieved in the study were acknowledged with awards at many
international scientific congresses ( Medichem 1999, SOT 2006,
etc). She was a national coordinator and participant in several
European projects on toxicology and public health as well as
numerous Bulgarian research projects on regulatory toxicology, occupational hand
public health. She was a head of an accredited research laboratory center of cosmetic
products (2005- 2007). Prof. Lyubomirova has specialties in toxicology, occupational
health and health economics. She is a European register toxicologist at Eurotox.
President of the Bulgarian toxicology society at the Union of the Medical Specialists in
Bulgarian. Member of the expert council at the Bulgarian National Association of
cosmetic products. She has more than 100 publication in the areas of risk assessment,
regulatory toxicology and occupational health. She has successfully passed a course
“Safety Assessment of Cosmetics in the EU - Training Course 2016” , Vrije University
Brussel. She is National consultant in occupational health at the Ministry of health and
National secretary for Bulgaria of the International commission of occupational health
(ICOH). Chief editor of the journal “Occupational health and work ability”.
Kalina Georgieva is a physicist, graduated in Sovia University
“St. Kliment Ohridski” with the specialization of
Thermodynamics and especially of Thermodynamics of
emulsion formation, stability, and rheology.She works in
cosmetics field since 2007 as a director of the R&D department
of Lidera Trading and actively participates in the development
of innovative textures and formulas. Also she closely monitors
the latest findings in active ingredients and applies them in new
types of cosmetics with corrective effect and fast results.
Tsvetelina Borislavova Maymarova Founder and owner of
Lidera Group – leader company for importing, distribution and
representation of the 22 International brands of equipment,
products and methodologies in the field of Beauty and SPA
industry. Representative and a senior class of professional
cosmetics as: BDR - Germany, Innovation and New Laser
Technology, ENERGIST - England, Phyt’s - France, NORE
BODE - Germany, Alex Cosmetics - Germany, Vismara - Italy.
Exclusive representative of Decléor, part of L'Oréal Group.She
has more than 25 years of experience in the field of Beauty and
SPA treatments. She is a founder of the National Association of Cosmetics “Health and
Beauty”, Bulgaria, vice president of the Association AMSPIKZ, chairman of the
department SPA & Cosmetics, chairman of working group “Curriculum”. Also, an
expert at the National Agency and is one of the major in the development and
implementation of changes to the European Beauty standards. Mrs. Maymarova is a
certified international instructor of applied cosmetics, IPL and photo technologies and a
professor in Lidera Academy. She is a founder of EcoSpa, ProfiDerm, Dr. Derm and
Beauty Expert professional beauty brands.Become a winner of the title “Knight of the
Blue Cluster” for disseminating a new culture of communication and utilization of water
resources – nominations, served by representatives of the United
Nations.Businesswoman of the year 2012 and in 2015 has been selected for
Businesswoman for the past 15 years.Winners of prizes for SPA Therapy of the year
2010; Balkan SPA products of the year 2012; Inter Charm 2013 in Moscow for most
original ethno concept; World SPA & Wellness Awards in London 2014 for SPA
Products; Awards for Innovation and Novelty for 2014 by Bulgarian SPA Association
– BUBSPA.Member and nominee president of Rotary Capital Club - Sofia.
Prof. Dobriana Sidgjimova, PhD graduated Sofia University in
1998 with subject Russian Philology with a Master`s degree. In
2001 she defended Master`s degree in Public Relations at the Sofia
University.In 2003 she obtained Master`s degree in Health
management at the Medical University of Sofia in the Faculty of
Public Health. In 2005 she defended a PhD thesis. Her professional
experience started as a State Expert in the PR Department of the
National Health Insurance Fund. In 2006 she became an Assistant
Professor at the Faculty of Public. Health in the Medical University
of Sofia. Since 2008 she is an Associate Professor In The Faculty Of Public Health,
Medical University, Sofia. In 2014 obtain "Health Economics" speciality.Till 14th of
May 2015 she was Chairman of Board of Directors of BADI.