2023 г.

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. ....more | Photo Gallery


 

DRUG REGULATORY AFFAIRS - update | Training Course | MODULE 3 - 01.12.2023 | Regulatory - Update | Online event

 

Program 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.

 



Program 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

Program | CV Lectures

 


 

05.06.2023

June 01, 2023 | Annual Congress of BADI 2023 – Pharmaceutical strategy – update

Program | CV Lecturers

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 Hospital  & Aula "Prof. Dr. Alexandar Chirkov".

The event was attended by nearly 100 people, including representatives from regulatory authorities, industry, academia and others. more...

Media:

Българската асоциация за лекарствена информация (БАЛИ) коментира ексклузивни новини за европейското фармацевтично законодателство на проведения  Международен Конгрес: Annual Congress of BADI’2023 – New EU Pharmaceutical Strategy – update|June 01, 2023, вестник “Форум Медикус”, бр. 13, 21. VI. 2023,  стр. 7



 

FOUNDATION SKILLS IN DRUG REGULATORY AFFAIRS | MAY 18-19, 2023 | 2-DAY TRAINING COURSE

Program | CV Lecturers

One Day Training Course | Pro bono Event | Free for BADI members 2023 | Program and Registration form | CV Lecturers

On May 18 and 19, 2023, the traditional Annual Course Foundation Skills in Drug Regulatory Affairs was held at  "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.