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.
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.
05.06.2023
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
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.
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
On
March 31, 2023, BADI held the first online seminar of the year for
members 2023. Over 90 individual and corporate members attended remotely
to hear the actual topics of Pharmaceutical sector. Our experienced
lecturers were Prof. Tatyana Benisheva, MU-Sofia, President of BADI, who
presented the issue – "Cosmetics - COSING, NCPN, Cosmetovigilance". RumyanaSharenkova presented the issue - "Authorisation of Мedicinal Products with Established Recipe - Specifics in Bulgaria". The
topic "Logistic of Medical Devices", presented by Vera Panayotova,
caused an interesting discussion after end of the presentation, and
Assoc. Prof. Maria Dimitrova, M.Pharm, MSc, PhD presented the current
trends in Medical devices and the new HTA Regulation. The main
moderator of the event was the President of BADI - Prof. Tatiana
Benisheva who led the session and many questions came from the audience
in term of the new HTA Regulation. After the end of the One Day Training Course, BADI held an Annual General Assembly Meeting.
DRUG REGULATORY AFFAIRS – update | Training course in 3 modules | 07.10.2022, 4.11.2022, 02.12.2022
15/12/2022 TRAINING COURSE IN DRUG REGULATORY AFFAIRS 2022 COMPLETED Early Packet Registration 2023 is now open, with up to 55% off the regular entry fee. On December 2, 2022, the Bulgarian Drug Information Association held the third and final module of this year's Drug Regulatory Affairs, Training Course 2022. The virtual event brought together over 100 regulatory experts from industry, academia and regulatory bodies. In the first session, Bulgarian experts from BDA and the industry participated. In the second session there were a special guest speakers: Dr. Ingrid Klingman - President of the European Forum for Good Clinical Practice (EFGCP) and President of the Pharma Train Federation, who presented the topic: Implementation of Clinical trials - Regulation EU No 536/2014 (in force 01.02.2023) and Mihai Rotaru - European Federation of Pharmaceutical Industries and Associations (EFPIA), who introduced the topic: New HTA Regulation (EU) 2021/2282 | 15.12.21 – update. More.....
07/11/2022
FOR OR AGAINST ARTIFICIAL INTELLIGENCE IN MEDICINE SAFETY Over 90 experts from the industry, BDA and MU-Sofia participated in the second event of the Drug Regulatory Affairs, Training course 2022, which was held in a hybrid format. Issues and problems from practice, of primary importance for their successful resolution, were put on the agenda and discussed. 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. Due to the impossibility of traveling to Bulgaria, some of the lecturers participated online -Prof. Burkhard Str?ter, Prof. Dr. Folker Spitzenberger and Dr. Alexander Natz, LL.M., Secretary General, European Confederation of Pharmaceutical Entrepreneurs (EUCOPE), who presented the exclusive theme The Implications Of The New EU HTA Regulation For Companies.
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
01/04/2022Radiopharmaceuticals & Food supplements - current regulatory aspects – BADI probono 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
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.
