2024 Рі.
19.06.2024 Рі.
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.В Photo Gallery
06.06.2024 Рі.
On May 30 and 31, 2024 was held the limited two-day Рўraining 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 Рі.
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.
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.
2023 Рі.
It has been another successful year for the BADI Association.
We continue the tradition every year, increasing the number of our trainings, lecturers and course participants. BADI has organized over 107 trainings for more than 7000 experts, with over 530 lecturers from Bulgaria and other EU countries, in the last 13 years.
On December 08, 2023 BADI organized a Christmas party with guests from the state administration, Ministry of Health, BDA, NCPRMP, speakers and activists of the Association, representatives of the pharma industry, mainly heads of regulatory departments or directors of branches of pharmaceutical companies in Bulgaria. ….moreВ |В Photo Gallery
DRUG REGULATORY AFFAIRS – update | Training Course | MODULE 3 – 01.12.2023 | Regulatory – Update | Online event
ProgramВ |В В Lecturers Module 3
8.11.2023
On November 3, 2023, was held Module 2 | Round Table Discussion – Hot Regulatory Issues | In person event of DRUG REGULATORY AFFAIRS – update | Training Course at Hotel Forum, where more than 90 experts from the pharma industry were present. Were discussed the changes to the new pharmaceutical legislation, which concern authorization procedures, variations and renewals, product information, intellectual property, clinical trials, safety and HTA, in connection with the so-called “Pharmaceutical Package”:
- Regulation of the European Parliament and of the Council – Brussels, 26.4.2023 COM(2023) 193 final 2023/0131 (COD) and amending to
Regulation (EC) No 1394/2007; Regulation (EU) No 536/2014 Regulation (EC) No 726/2004; Regulation (EC) No 141/2000; Regulation (EC) No 1901/2006.
Thanks to the speakers and guests from the Bulgarian Drug Agency, all points and statements of the document were discussed. The Deputy Minister of Education – Prof. Genka Petrova, started the event with opening remarks.
ProgramВ |В В Lecturers Module 2
10.10.2023
Over 90 regulatory experts participated in the first module of this year’s DRUG
REGULATORY AFFAIRS TRAINING COURSE. The event took place on October 6, 2023,
in a completely online format and presented some of the most current and hot topics in the
sector in the field of drug safety. Speakers were well-established names in the pharmaceutical industry
regulations in Bulgaria and the region, as well as from BDA, the following directions: PhV and clinical safety – Update;
PhV – Hybrid Audits – (combination of remote and online); 10 years from the extensive reforms of the PHV rules in 2010;
PhV and clinical safety reporting, based on Regulation (EC) 536/2014; PhV – Inspections;
Most common findings at audits and inspections – practical examples.
DRUG REGULATORY AFFAIRS – update | Training Course | MODULE 1 – 06.10.2023 – Pharmacovigilance – update | Online event Only
05.06.2023
June 01, 2023 | Annual Congress of BADI 2023 – Pharmaceutical strategy – update
On June 01, 2023 Bulgarian Association for Drug Information (BADI) organized and held the Annual International Congress: Annual Congress of BADI 2023 – Pharmaceutical strategy – update |Venue: University HospitalВ & Aula “Prof. Dr. Alexandar Chirkov”.
The event was attended by nearly 100 people, including representatives from regulatory authorities, industry, academia and others.В more…
Media:
Българската асоциация Р·Р° лекарствена информация (БАЛР?) коментира ексклузивни РЅРѕРІРёРЅРё Р·Р° европейското фармацевтично законодателство РЅР° проведения Международен Конгрес: Annual Congress of BADI’2023 – New EU Pharmaceutical Strategy – update|June 01, 2023, вестник “Форум Медикус”, Р±СЂ. 13, 21. VI. 2023, стр. 7
FOUNDATION SKILLS IN DRUG REGULATORY AFFAIRS | MAY 18-19, 2023 | 2-DAY TRAINING COURSE
One Day Training Course | Pro bono Event | Free for BADI members 2023 |В Program and Registration formВ |В CV Lecturers
On May 18 and 19, 2023, the traditional Annual Course Foundation Skills in Drug Regulatory Affairs was held atВ “Prof. Dr. Alexander Chirkov Hospital”, which was attended by representatives of the pharmaceutical industry, and speakers were well-established professionals in the field of healthcare, as well as leading experts from the Bulgarian Drug Agency (BDA), in the person of Assoc. Lubina Todorova and M. Pharm. Rosalina Kulaksozova.
The two-day entry-level training, held annually, is aimed at representatives who would like to join the pharmaceutical industry, technical associates and staff. The main topics in the training were: Introduction to regulatory issues; Types of drugs; Molecule to medicine; Competent authorities and procedures for market authorization; Pharmacovigilance – AE reporting; Market access – Introduction; Advertising. For the second day of training, a quiz with questions and certificates for participation in the training course were prepared.
http://badibg.org/index.php?option=com_content&view=article&id=8&Itemid=7
| Free workshop for delegates from Bulgaria / CEE countries!
Dear Colleagues, The DIA Advisory Council of Europe (ACE) is organising a free workshop on the Influence of the EU Legislation on the Bulgarian Drug Industry. The workshop is scheduled for 26 May 2011 in Sofia.
Click on the image below to view the ACE Workshop programme. To register for this workshop, please go toпїЅwww.diahome.org >пїЅConferences/Meetings > Find a Meeting > Enter Keyword: 11119 or clickпїЅhere and then click on пїЅRegisterпїЅ at the bottom of the page. In order to facilitateпїЅyour registration please use that guide. This workshop has limited capacity -пїЅplease register early
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Clinical _Trials _Emerging Economies_Prague. 21-22.April. 2009
Hong Kong Clinical trials 13-15.11.2009
Variation Regulation – 27.11.2009