07/11/2022 „ЗА“ ИЛИ „ПРОТИВ“ ИЗКУСТВЕНИЯ ИНТЕЛЕКТ В ЛЕКАРСТВЕНАТА БЕЗОПАСНОСТ Над 90 експерти от индустрията, ИАЛ и МУ-София участваха във второто събитие от Курс по лекарствени регулации, който се проведе в хибридна форма. На дневен ред бяха поставени и дискутирани въпроси, и проблеми от практиката, с първостепенно значение за успешното им разрешаване. More...
18/10/2022 LATEST IN MEDICATION SAFETY PRESENTED IN FIRST MODULE OF DRUG REGULATORY AFFAIRS TRAINING COURSE 2022
Unprecedented transparency of all PRAC decisions during the pandemic
Over 90 regulatory experts participated in the first module of this year's DRUG REGULATORY AFFAIRS TRAINING COURSE. The event took place on October 7, 2022, 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 regulations in Bulgaria and Germany.
REVOLUTION IN REGULATORY AFFAIRS – HOW THE PANDEMIC IS SHAPING THE REGULATORY FIELD AND SCIENCE – INTERNATIONAL ANNUAL CONGRESS OF BADI` 2022
On June 02, 2022 (St. Ekaterina Hospital, Aula Prof. Dr. A. Chirkov) BADI realized the annual congress Drug Regulatory Affairs – update 2022, under the main theme - Revolution in Regulatory Affairs - How the pandemic is shaping the regulatory field and sciеnce. The international event gathered in one event one of the most experienced and professional expert in the field of drug regulatory affairs in EU.
FOUNDATION SKILLS IN DRUG REGULATORY AFFAIRS` 22| MAY 12-13, 2022 | TRAINING COURSE
On May 12 and 13, 2022, BALI realized the traditional annual training Foundation Skills in Drug regulatory Affairs. 24 representatives of the pharmaceutical industry took part in the training.The training course presented basic information on the topics: - Introduction in Regulatory Affairs, regulatory approaches of medicinal products, Medical devices, Food supplements, Cosmetics, Introduction in market assess - Prof. Tatyana Benisheva - Types of Drugs; Molecule to medicine – basic understanding of Clinical trials phases, risk / benefit; Do – Do Not; Classifications & ATC Code, Pharmacovigilance - AE reporting - Margarita Strokova, MD - Competent authorities and Marketing Authorization Procedures; Centralized Procedure (CP); Mutual Recognition Procedure, Decentralised procedure, National Procedure (MRP, DCP, NP), Pricing, Medical information, SmPC; Product complaints/MI inquiries; Handling enquires - Daniela Cherneva, PhD - Variations, Renewal - Lubina Todorova, MD - Reimbursement, HTA – Introduction - Elka Boncheva - Clinical data transparency – Dimitar Dimitrov - PSUR, EudraVigilance – Valentin Kopanarov - Advertisement - What is promotion, Off –label use, Ethical promotion – Prof. Valentina Petkova - Good distribution practice (GDP) &Good manufacturing practice (GMP) – Valeria Sarbinova
15/04/2022
Radiopharmaceuticals & Food supplements - current regulatory aspects – BADI pro bono seminar for members 2022 | April 15, 2022 | Second edition
01/04/2022 Radiopharmaceuticals & Food supplements - current regulatory aspects – BADI pro
bono seminar for members 2022 | April 1st 2022
On April 1st, 2022, BADI held the first in person seminar of the year for members 2022. Over 50 individual and corporate members were presented in the hall to hear the update on the topic of Radiopharmaceuticals - regulatory aspects, Food supplements - current regulatory aspects. Our experienced lecturers were Dr. Kamen Nikolov – Director from division of the Bulgarian food authority – Bulgarian Food and Safety Agency (BFSA) with more than 10 years experience there. Dr. Ludmil Antonov an expert of the Bulgarian Drug Agency (BDA) in that field– presented the difficult issue – radiopharmaceuticals with the challenges for producers and regulators. The moderators of the sessions were Prof. R. Shekerdzhiyski, Stella Shekerdzhiyska and Valeria Sarbinova. The main moderator of the event was the President of BADI - Prof. Tatiana Benisheva who led the both sessions and many questions came from the floor especially in term of the new Food supplement regulation from December 2021. That was the first in person event of BADI, after the end of the emergency epidemiological situation in Bulgaria and all participants were very excited and active.
10/12/2021
At a boutique ceremony held on December 10, 2021, the Bulgarian Association for Drug Information (BADI) presented plaquets to pharmaceutical companies, on the occasion of 10th anniversary, which the Association celebrated in 2020. Among the winners in the industry in Bulgaria are: - Medokemi Ltd. for FASTEST GROWING GENERIC COMPANY IN CNS - Astelas Pharma Bulgaria for LONG – TERM SOCIAL CONTRIBUTION IN THE FIELD OF TRANSPLANTS IN BULGARIA - Novartis Bulgaria EOOD for BRINGING GENE THERAPIES TO PATIENTS - Smart S Pharma for INNOVATIONS IN THE FIELD OF NEUROLOGY AND REHABILITATION - Ecopharm EOOD for FASTEST GROWING GENERIC COMPANY
