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DRUG REGULATORY AFFAIRS - update | Training Course | 3 modules |
04.10.2024 – 06.12.2024 | Online event | In person
Program Modules 2-3 | Registration form

Program Module 2





Program Module 1| Highlights Module 1

Място на провеждане: Hotel Forum, Conference Hall Central
41 Tsar Boris III Blvd./on the corner with “Sofiiski geroi” str.
or GPS address: 2 Sofiiski geroi str.
Sofia 1612, Bulgaria


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.



   


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    For more information: +359 2 955 85 86; +359 889 919 655


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