Why did you participate in the Biomapas Academy?
Everything started when I had a trip to a career fair during my studies. This was the first time I met Biomapas in person as there were several lecturers that presented the company itself and its activities. I remember thinking that I would like to work with this team as it piqued my interest.
Later, when I was working on my master’s degree, I came across an advertisement on social media for the Biomapas Academy. I already knew that I wanted to learn more about the pharma industry and was interested in various opportunities, so I applied for this opportunity.
How was your experience during the three months?
The Academy was a continuous cycle spanning several months of interesting lectures from true professionals with extensive knowledge. During this short time, I learned a lot about product development, research, safety information and its systems, different possible roles and their responsibilities, and new opportunities where young specialists can grow and find their place in the life sciences industry.
What did the future hold for you after the Academy?
A while after the Academy, I officially became part of Biomapas and its big family! With my background being an MPharm, I was always interested in drug safety. Therefore, I am working in the Pharmacovigilance Department as a Pharmacovigilance Project Management Assistant. I must say there are many interesting things to learn and experience that I am looking forward to with my team.
What would you say to the future participants?
If you are thinking about participating in the Academy, do not hesitate. Being an alumnus, I can say that you will definitely see the pharma industry from within. It will broaden your understanding; you will gain needed knowledge and experience in life sciences and will be able to apply that information working in your chosen field. I hope to see you at Biomapas!
Biomapas Academy
What is Clinical Research? Regulatory Affairs? Pharmacovigilance?
Proper Publicizing in CEECs – Path to Successful Social Media Commercials
With the growth of social media network users all over the world, there is no doubt that one of the most widely used channels for promoting is social media. Statistics show that Facebook and Instagram were used actively with more than 3.4 billion people daily by January 2020. Therefore, since medical devices and over-the-counter medicines are being more often promoted by commercials on social media nowadays, there is a greater risk of hidden or misleading advertisements.
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.
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.
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.
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.
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.
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.
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.
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.
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.
