Why did you decide to participate in the Biomapas Academy?

The first time I heard about Biomapas Academy was from a friend who was already working in the pharmacy field. She sent me an advertisement for Biomapas Academy, which highly intrigued me. As I was in my last year of life science master studies, I wanted to discover my potential career possibilities and learn more about clinical trials. Therefore, without long thinking, I filled in the application form. I was very happy to be selected from quite many applicants and be invited to attend Biomapas Academy.

How was your experience during the three months?

We had four months of weekly lectures on different topics. They were related to the organization of clinical trials, regulatory affairs and pharmacovigilance of various medical products. Biomapas experts who resented the lectures even shared their personal experience and actual practical examples with us. We have been able to get acquainted with Biomapas company and its work specifics. Here we could expand our knowledge of the pharmaceutical industry.

 

How do you feel after graduating from the Academy?

I feel thrilled for taking a chance to participate in this unique project. After graduating from all the courses and tasks, I was absolutely honoured to be selected as the best student of Biomapas Academy 2020 and receive a scholarship. However, I mostly appreciate the valuable knowledge and experience I believe will be helpful for my future career. I think Biomapas Academy definitely contributes to the education of young professionals and is very useful, especially for those who want to get to know their professional opportunities better.

Biomapas Academy

What is Clinical Research? Regulatory Affairs? Pharmacovigilance?

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

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

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.

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What is a Safety Signal?

What is a Safety Signal?

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.

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

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

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?

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Local Literature Surveillance Challenges and Specifics in the EU, CIS and LATAM regions

Local Literature Surveillance Challenges and Specifics in the EU, CIS and LATAM regions

PV legislation introduced by the European Commission in 2012 and GVP guidelines together with local requirements committed each MAH to perform literature review in countries where their products are present. Compliance with mandatory requirements and guidelines is not always a simple task when local requirements and specifics come along. In this article, we will take a closer look at these challenges and specifics for local literature surveillance in different regions as EU, CIS and LATAM.

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

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

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.

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

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

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.

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Running a clinical trial in the Baltic states

Running a clinical trial in the Baltic states

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.

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Falsified Medicines Directive Implementation – Marketing Authorization Holder Perspective

Falsified Medicines Directive Implementation – Marketing Authorization Holder Perspective

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.

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Biomapas appoints Chief Financial Officer

Biomapas appoints Chief Financial Officer

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.

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Remaining Vigilant and Compliant after Brexit: What’s next? (Latest Updates)

Remaining Vigilant and Compliant after Brexit: What’s next? (Latest Updates)

On 29th March 2017 UK submitted the notification of its intention to withdraw from the EU. This means that UK will become a ‘third country’ from 30th March’19. Even though leaving the EU with a deal remains the Government’s top priority, UK drug agency is publishing a series of guidance documents for industry and other stakeholders covering the proposed arrangements for the regulation of medicines, medical devices and clinical trials, if UK leaves EU with no deal.

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Big Enough To Cover  All Your Needs. Small Enough To Care.

Discover the tailored solutions that Biomapas provides to accelerate your clinical trials and optimize your drug development process.

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