In the process of marketing authorization, competent authorities classify medicinal products as the subject or not-subject to medical prescription. However, the classification of medicinal products can be reevaluated and changed via a regulated procedure. When considering a switch, many factors like characteristics of market and population, local policies, advertising, confidence in regulatory authorities and other, influence the outcome. Though, the safety of patients has the highest priority. So, what questions should you ask?
Russia is a very perspective country for international clinical trial conduction. The first international clinical trial was set up in Russia about 20 years ago only, and from than country kept a great potential for market development. In 2018 health authorities (HAs) approved 653 clinical trials (CT) in Russian Federation, less in overall numbers compared to the same indicator from 2016 – 898 approved CTs. However, this decrease was observed across all types of clinical trials except for international multicentre clinical trials (IMCT).
Ramune Rukiene joined Biomapas as Director Regulatory Affairs to further strengthen continued growth and geographic extension of Biomapas. Ramune will play an important role by leading regulatory activities, ensuring highest service quality and maximizing the efficiency of medicinal and veterinary product placement into the market. Furthermore, Ramune will work together with the management team to set a regulatory affairs strategy and to deliver unmatched service experience and quality in the market.
The number of clinical trials worldwide is increasing more than 10% each year due to the new diseases, further research for better health products and development of new drugs. Though, for a successful clinical trial, there is a major challenge – patient recruitment, which is essential and the most challenging factor due to the increasing number of new clinical trials. In order to achieve the required patient recruitment, sponsors are looking for different solutions.
The IDMP is a general term by which the 5 ISO data standards are referenced: ISO 11615 (regulated medicinal product information), ISO 11616 (regulated pharmaceutical product information), ISO 11238 (substances), ISO 11239 (pharmaceutical dose forms, units of presentation, routes of administration and packaging) and ISO 11240 (units of measurement). – which are being refined and implemented by regulatory bodies.
In the past five years, an average of 175 clinical trials are being initiated in the Baltic states each year. An average of 64,8% of the population in the Baltic states are in the age from 15 to 65 years old, the main target audience for clinical trials. Furthermore, a large pool of treatment-naïve subjects is available compared to other EU countries or the US. Patients with special therapeutic diseases are transferred to the main central hospitals.
Falsified Medicines Directive (FMD) 2011/62/EU which aims to increase the security of manufacturing and delivery of medicines across Europe as well as protect patients and prevent falsified medicines from entering the supply chain has come in force Feb 9th, 2019. With the first quarter almost over, it is a great opportunity to look back and share the experience. The new requirements for safety features to appear on the packaging of all prescription medicines.
Filip Risteski was recently appointed as Chief Financial Officer (CFO) at Biomapas and will be one of the key players further strengthening continued growth of Biomapas. Filip will report directly to Audrius Sveikata, Biomapas Chief Executive Officer. As a CFO he will be responsible for placing control over finance function and financial strategy, by maximizing efficiency and ensuring highest quality standards. Furthermore, Filip will work with a management team on implementation of overall company business strategy.
In order to support the continued growth of Biomapas, the company has appointed a Director of Human Resources, Monika Lakytė. “We are excited to have Monika as a member of our management team. She shares our values and our focus on future goals, her professional experience in recruitment process and personnel management will endorse our continued growth. People as Monika is the result of highest quality standards in our work,” said Juozas Buitkus, Biomapas COO.