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?

How Mergers and Acquisitions of Pharma Companies affect Regulatory Affairs?

How Mergers and Acquisitions of Pharma Companies affect Regulatory Affairs?

It is easy to notice that Mergers and Acquisitions (M&A) have become a frequent occurrence in the Pharmaceutical industry, especially during the previous decades. Pharma industry is one of the leading industries in the number of M&A and the size of investments for such transitions. The value for M&A in the pharmaceutical sector was $221 billion in the first half of the year 2015. In 2019, the worth of pharma companies M&A activities have reached $357 billion.

read more
CMC: Best Practice in Effective IND and IMPD writing

CMC: Best Practice in Effective IND and IMPD writing

This time we will focus on technical writing and preparation for it. Also, I will provide some primary recommendations for CMC writers. The IND/IMPD being a regulatory document, has the same structure as CTD dossier. However, it includes remarkably less information on the developmental product, yet, the technical writers should understand that they will need to prepare the document in the way to reflect the actual production process and control further during the development in the later clinical phases.

read more
What do you need to know while preparing RMP for EAEU and CIS region?

What do you need to know while preparing RMP for EAEU and CIS region?

Preparation of Risk Management Plan (RMP) for a specific medicinal product usually is the responsibility of the Qualified Person Responsible for Pharmacovigilance (QPPV) and its team. Thus, QPPVs and their team’s should be familiar with legislation requirements for RMP preparation in different regions. Within this article, we will concentrate on the Eurasian Economic Union (EAEU) and identify specific conditions of EAEU countries as well as to try to understand the expectations of Competent Authorities in this region.

read more
CMC: Effective Writing of IND and IMPD

CMC: Effective Writing of IND and IMPD

Do we truly know how to ensure IND or IMPD Quality (CMC) part is written in good quality, consistent and clear technical language? How to effectively manage the writing process? In this article, I will focus on these questions and the initial IND/IMPD, required to start clinical investigations in humans. Furthermore, I will provide the key features and practical advice on how to deliver effectiveness. Firstly, we have to define the team in order to understand if the organization has capabilities to do CMC writing in-house or needs to outsource.

read more
Biomapas appoints Head of Global Regulatory Affairs

Biomapas appoints Head of Global Regulatory Affairs

May 2020 – Olga Bernardova joins Biomapas as Head of Global Regulatory Affairs to lead the regulatory affairs department and to ensure the best processes and means to serve Biomapas growth and international expansion. As a functional and full outsourcing solution provider, with offices in Lithuania, Switzerland, Sweden, Russia, Georgia, Ukraine, Poland and Kazakhstan, Biomapas continues to expand its international team and further increases capabilities for client-oriented solutions.

read more
Regulatory Documents Translation Process – How to Ensure Consistency and Correctness

Regulatory Documents Translation Process – How to Ensure Consistency and Correctness

Mistranslation of regulatory documents such as a summary of product characteristics, product information leaflets and instructions for use, could have a negative impact for the company and most importantly could lead to serious consequences to a patient’s health. In 2007, as a result of inaccurate translation, 47 patients had badly implanted knee prostheses. An outer package labelled in English included different information.

read more

Biomapas Opens a New Office in Kazakhstan

Biomapas has announced the opening of a new office in Central Asia. The new location in Kazakhstan strengthens Biomapas presence in the CIS region and further improves flexible and reliable clinical, regulatory and pharmacovigilance service delivery to the global life science industry in emerging markets. As a functional and full outsourcing solution provider, with a new office in Almaty, Biomapas continues to expand internationally.

read more
MAH is the Key to the Pharmacovigilance: 10-year Lithuania Statistics

MAH is the Key to the Pharmacovigilance: 10-year Lithuania Statistics

Even though the drug safety and reporting of the adverse effects is the responsibility of all Health Care Providers, pharmacists and patients, statistics show that the one in charge is Marketing Authorization Holder. During the National semi-annual conference „Pharmaceutical News“, State Medicines Control Agency presented the statistics of suspected ADRs reporting in Lithuania.

read more
Running a Clinical Trial in Ukraine

Running a Clinical Trial in Ukraine

Despite the fact that Ukraine is the largest country in Eastern Europe with a large population of treatment-naïve patients, well organized public health care sector and significant number of medical sites accredited for clinical trial conduction, country has utilized only 15% of its current potential for hosting clinical trials. During 2017, the European Medicine Agency (EMA) gave positive recommendations on 94 new drug applications and 49 of them were tested in clinical trials in Ukraine. During the same year, the US FDA approved 151 new drugs, and 28 of them were also studied in Ukraine.

read more
Biomapas appoints Head of Global Pharmacovigilance

Biomapas appoints Head of Global Pharmacovigilance

March 2020 – Clinical, regulatory and pharmacovigilance solution provider to the global life science industry, Biomapas, appointed leading pharmacovigilance professional Martijn van de Leur as Head of Global Pharmacovigilance. With offices located in Lithuania, Switzerland, Sweden, Russia, Georgia, Ukraine and Poland, Biomapas provides services in 60+ countries across 4 continents. As a functional and full outsourcing solution provider, Biomapas continues to strengthen its international team and geographical coverage of its services globally.

read more

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.

Clinical Research

Regulatory Affairs

Pharmacovigilance

Medical Information