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EARLY REGISTRATION FORM 2025. PROGRAM AND REGISTRATION FORM
DRUG REGULATORY AFFAIRS - update | Training Course | 3 modules |
04.10.2024 – 06.12.2024 | Online event | In person
Registration form
Program Module 3
Module 2 dated 22 of October, 2025
The event provided a platform for exchanging ideas and addressing the most pressing regulatory concerns, Artificial Intelligence (AI). 3 years
is a transitional period for all devices Class II-IV and those with AI need to be recertified. Strategy in Drug Development was presented at FDA and EMA and the presentation is a good manual for those who would like to have a new start in the innovative industry. Pharmacovigilance
is an important topic and the new changes from August 2024, Module XVI - Risk minimization measures (Rev.3) was a focus of the presentation. Safety of Biosimilars of 6 INN (Adalimumab, Bevacizumab, Trastuzumab, Rituximab, Infliximab, Etanercept) shows the insight of 6
INN of biosimilars to their reference produc. Regulatory frame on nonregistered products and Compassionate use in Bulgaria was another important topic. Read more
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Highlights of the presentations in English Language Module 2
15.10.2024 г. Program and CVs Module 1 04.10.2024 | Highlights before Module 1
Venue : Hotel Forum, Conference Hall Central
41 Tsar Boris III Blvd./
Sofia 1612, Bulgaria On October 4th, BADI held Module 1 live with over 80 participants, including lecturers and moderators from the Bulgarian Drug Agency (BDA), the industry, and academia. The topics were dedicated to audits and inspections of pharmacovigilance (PV) and quality (QA) systems, signal management, reporting of adverse drug reactions by healthcare professionals, as well as the switch of medicines’ prescription status from OTC to prescription and vice versa, directly related to safety. Summaries of the presentations by the lecturers, along with their references, can be found in this document, which is prepared in English and in Bulgarian language (Highlights in Bulgarian and Highlights in English Language) please read below the links: Highlights of the presentations in Bulgarian Language
Highlights of the presentations in English Language
SESSIONS
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19.06.2024 г. On June 6, 2024 the Annual Congress of the Bulgarian Association for Drug Information (BADI) - Pharmaceutical Legislation was held in University
Hospital "St. Ekaterina" | Aula "Prof. Dr. Alexander Chirkov".
It is of great professional importance for BADI that this significant forum was attended by representatives of the pharmaceutical industry, academia,
guests from the Ministry of Health and the Bulgarian Drug Agency, as well asspeakers - leading experts from Bulgaria and the EU.
We are pleased to have the Minister of Health, Dr. Galya Kondeva, send a congratulatory address on the occasion of the Annual Congress of BADI, vice president of the BADI- Prof. Dobriana Sidjimova read to the wide audience. 
06.06.2024 г.
On May 30 and 31, 2024 was held the limited two-day Тraining Course:
FOUNDATION SKILLS IN DRUG MARKETING AUTHORIZATION PROCEDURES OF MEDICINAL PRODUCTS IN THE EU, WORKSHARING OF MPS, GMP, GDP, organized by Bulgarian Association for Drug Information (BADI), at University Hospital "Sveta Ekaterina", Hall 2.
Speakers this year were established experts in the field of health care, who presented their presentations in a professional manner and shared their
experience with the audience. Experts from Bulgarian Drug Agency (BDA) shared how the EMA Commissions work, as well as useful information for the authorization of medicinal products.
30.04.2024 г. On 24.04.2024, the exclusive training seminar was held on the topic: PRICING AND NEW MECHANISMS AFFECTING DRUG REIMBURSEMENT SYSTEMS IN THE EU,
incl. in the R. BULGARIA, organized by the Bulgarian Association for Drug Information (BADI), with the joint participation of the National Council on
Prices and Reimbursement of Medicinal Products (NCPRMP). The event discussed the Bulgarian and European legislation, regarding prices and reimbursement, and Regulation (EU) 2021/2282 on HTA and its
implementation, as well as the National Health Insurance Fund policies. Lecturers in the training seminar were leading experts from the NCPRMP and the NHIF.
Dr. Vladimir Afenliev - Director of the "Drug Policy" Directorate of the NHIF, presented the topic: "Updates in the treatment, reimbursement of medicines and possibilities of the Drug Policy of the National Health
Insurance Fund", and representatives from the Council on Prices and Reimbursement of Medicinal Products, represented by the Chairman of the
NCPRLP - Assoc. Silvia Terezova, Mag.- Pharm. Boryana Ivanova, Prof. Manoela Manova and Prof. Alexandra Savova presented the topics: "Pricing in the Republic of Bulgaria", "European legislation Regulation (EU) 2021/2282 on
HTA" and " Implementation status Regulation (EU) 2021/2282 on HTA" . Special guests and participants of the event were representatives from the
Ministry of Health, experts from the institutions, the Academy and the industry, who took an active part in the discussions, and the Vice Rector
for Science and Accreditation at the Medical University - Sofia, sent a congratulatory address, which was read to the audience of the Forum from
Deputy the Chairman of BADI - Prof. Dobriana Sidjimova.
Project: Development of proposals for the improvement of citizen participation in pricing processes and drug reimbursement, formation and reporting of the public/budgetary funds for health care in the field of the medicines.
Beneficiary: Bulgarian Association for Drug Information (BADI)
Start date: 15.01.2019
Closing date: 15.01.2021
Total value of the project: BGN 87,525.01.
The project is implemented with the financial support of the Operational Program "Good governance" (OPDU), co-financed by the European Union through European Social Fund.
Priority axis 2 "Effective and professional management in partnership with civil society and business".
Procedure "Increasing civil participation in the processes of formulation, implementation and monitoring of policies and legislation”.
Project "Development of proposals to improve civil participation in drug pricing and reimbursement processes, formation and reporting of the public/budgetary funds for health care in the field of medicines" - No. BG05SFOP001-2.009-0022, is implemented with the financial support of Operational program "Good Governance", co-financed by the European Union through the European social fund.
Please send the completed application to
This e-mail address is being protected from spambots. You need JavaScript enabled to view it
For more information: +359 2 955 85 86; +359 889 919 655
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8 ноември 2019 г., Модул 2 – Pharmacovigilance, Part II 22 ноември 2019 г., Модул 3 – Regulatory Affairs – Update
Регистрационна форма: тук Място на провеждане: Хотел Форум София, бул. "Цар Борис III" № 41, Зала Централ
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