Submit RFI/RFP
All Posts By

Aivaras Aliukonis

Poland 2020

Biomapas strengthens its footprint in Poland in the run-up to its further growth in Central Europe

By | news1

February 2020 – Clinical, regulatory and pharmacovigilance solution provider to the global life science industry Biomapas announced strategic growth in Warsaw. With offices located in Lithuania, Switzerland, Sweden, Russia, Georgia, Ukraine and now in Poland, Biomapas provides services in 60+ countries across 4 continents. As a functional and full outsourcing solution provider, with a new office in Central Europe Biomapas will strengthen its international team and geographical coverage of its services.

Read More
Regina Auškalnienė, Head of Clinical Operations at Biomapas

Regina Auskalniene will lead Lithuanian Good Clinical Practice and Regulatory Affairs Association

By | news1

Regina Auskalniene, Head of Clinical Operations at Biomapas, was elected to lead Lithuanian Good Clinical Practice and Regulatory Affairs Association. The association unites middle size and global CROs in the Baltic countries and is focusing on creating the most efficient environment in Europe to deliver clinical trials. „Everyone in our association agrees that we can run much more clinical trials in the Baltic states, thus creating an attractive place for clinical research in the future,” said Regina Auskalniene.

Read More

Regulatory Affairs Outsourcing: From Baby Steps in Cost Savings to Long-Term Partnerships

By | news1

The trend of outsourcing continues to grow in the life science industry. Global regulatory affairs outsourcing market was valued at US $5.7 billion in 2018, and is expected to witness a compound annual growth rate of 11.9% over the period to 2026. Regulatory affairs outsourcing may vary in extent (from stand-alone service to full-scope solution), length (project based or long-term partnership with selected vendor), model (insourcing a dedicated expert for specific project or functional service provision), etc.

Read More
Josefina Jakobsson, MSc Pharmacovigilance Specialist Biomapas

What is a Safety Signal?

By | news1, Uncategorized

Occasionally we see the information of a safety signal for medical product, but what does it really mean? We can describe the safety signal as an indication for new and significant safety-related data for a marketed product. The new data could indicate a new potentially causal association between an adverse event, beneficial response and a medical product, or a new aspect of causal association that was previously known. Usually, a signal will be relevant for all products with the same active ingredient, including the combination products. Further, let’s look more at the main steps of the safety signal management.

Read More
Eglė Deimantavičiūtė, MSc, Medical Writer, Biomapas

Rx to OTC Switches – 5 Things You Need to Know before Considering a Switch

By | news1

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?

Read More
Oleg Kungurtsev, Manager Clinical Operations

What You Need to Know about Running a Clinical Trial in Russia?

By | news1

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).

Read More
Ramune Rukiene, Director Regulatory Affairs

Biomapas appoints Director Regulatory Affairs

By | news1

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.

Read More
Indrė Dryžienė MBI, MM

The CIS Region: Excellent Potential for Patient Recruitment but is there any Risk to Quality?

By | news2

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.

Read More
Gediminas Zvicevičius MPharm, Lead Pharmacovigilance Specialist at Biomapas .

The Predicted Impact of the ISO IDMP Standards Implementation Process Carried Out by the European Medicines Agency

By | news2

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.

Read More
Irma Ušinskienė, BSc, Associate Director Clinical Operations, Biomapas

5 things you need to know about running a clinical study in the Baltic states

By | news3

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.

Read More