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Biomapas Academy Alumni 

How to become a life sciences specialist?

Thinking about joining? Experience the academy through the alumni.

Every year, we select a limited number of applicants to become part of the Biomapas Academy, where they learn about Clinical Research, Regulatory Affairs and Pharmacovigilance. From theory to practice, we seek to answer all questions and lead young professionals into their careers.

Explore the experiences of our past students and how the academy impacted their professional journey afterwards. Read some success stories of newfound passions, changes in job fields, expanded understanding of the life sciences industry, and even completed internships.

Proper Publicizing in CEECs – Path to Successful Social Media Commercials

Proper Publicizing in CEECs – Path to Successful Social Media Commercials

Oct 2, 2020 | ,

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.

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How Mergers and Acquisitions of Pharma Companies affect Regulatory Affairs?

How Mergers and Acquisitions of Pharma Companies affect Regulatory Affairs?

Aug 12, 2020 |

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.

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CMC: Best Practice in Effective IND and IMPD writing

CMC: Best Practice in Effective IND and IMPD writing

Aug 6, 2020 |

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.

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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?

Aug 4, 2020 |

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.

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CMC: Effective Writing of IND and IMPD

CMC: Effective Writing of IND and IMPD

Jun 17, 2020 |

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.

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Biomapas appoints Head of Global Regulatory Affairs

Biomapas appoints Head of Global Regulatory Affairs

May 14, 2020 |

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.

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Regulatory Documents Translation Process – How to Ensure Consistency and Correctness

Regulatory Documents Translation Process – How to Ensure Consistency and Correctness

May 8, 2020 |

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.

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Biomapas Opens a New Office in Kazakhstan

Apr 30, 2020 |

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.

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

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

Apr 21, 2020 |

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.

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Running a Clinical Trial in Ukraine

Running a Clinical Trial in Ukraine

Mar 24, 2020 |

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.

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Biomapas appoints Head of Global Pharmacovigilance

Biomapas appoints Head of Global Pharmacovigilance

Mar 13, 2020 |

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.

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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

Jan 31, 2020 |

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?

Jan 6, 2020 |

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

Aug 2, 2019 |

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

Jul 4, 2019 |

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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Bridging The Gap.

From Academy To Industry.

Paulina P. Biomapas Academy

What set this experience apart was not just the theoretical knowledge but also the opportunity to learn firsthand from industry professionals, gaining insights into their daily routines and witnessing their genuine passion for clinical research. I am grateful to everyone who poured their hard work into this project, and I feel honored to have been a part of it. To those considering participation, I wholeheartedly encourage you not to hesitate. Embrace the opportunity, as you may discover, as I did, a newfound passion within the realm of clinical research.

Paulina Pupalė

Gabriele J. Biomapas Academy

I am glad that I got the opportunity to broaden my knowledge of clinical trials, regulatory affairs and pharmacovigilance from professionals in these fields. During the academy, you will obtain not just a huge amount of information but also remarkable friendships and connections, which could be beneficial in the future.

Gabrielė Juraitytė

Aurimas P. Biomapas Academy

Attending the Biomapas Academy was an enriching experience that surpassed my expectations. The lectures were comprehensive and well-presented, providing a thorough understanding of pharmacovigilance and regulatory affairs. The organizational aspect of the Academy was exemplary, with clear and comprehensive communication.

Aurimas Plaga

Ineta M. Biomapas Academy

Biomapas Academy broadens horizons and introduces clinical research very widely, as well as pharmacovigilance and regulatory affairs. After this academy, it’s much clearer and easier to understand what happens behind the closed doors of pharma.

Ineta Meldaikytė

Karolina K Biomapas Academy

Biomapas Academy is an educational program that connects participants with industry experts, offering practical insights in an engaging manner. I highly recommend it to those who want to explore a career in life sciences.

Karolina Koškinaitė

Monika B. Biomapas Academy

I came to know more about what interests me – the drug industry, and left with a clear mind where exactly I want to stand in this field.

Monika Bertašiūtė

Emilja G. Biomapas Academy

In this Academy, I truly broadened my knowledge of life sciences. Also, I should mention the people, the kind lecturers and the Biomapas staff; I even became friends with other participants!

Emilija Galkutė

Augustinas Drapeko

It was an amazing experience to learn and network with people with such passion for furthering the healthcare industry. I have found my passion towards the clinical trials and pharmacovigilance industry, which would not have been possible without the knowledge I gained from this academy. Forever grateful for this opportunity, and I highly recommend this academy to those who wanna learn and grow in their respective careers!

Rakshana Alexander

Academy student - Katarzyna Gancarz

I am very happy that I decided to attend this Academy. Here, I learned a lot of useful and interesting information, which allowed me to get a very clear picture of where I can further realize myself. I highly recommend this Academy to all young professionals who are still looking for themselves and don’t know which way to go next.

Gabrielė Juknevičiūtė

Academy student - Livija Skėrytė

I am grateful for the opportunity to attend Biomapas Academy. It definitely broadened my horizons in the pharmaceutical industry field. Even if you don’t plan to work in a CRO company, but you are interested in drug development, give Biomapas Academy a try; it is definitely worth the time and effort.

Guoda Pranaitytė

Academy student - Katarzyna Gancarz

It gives guidance in the complex and strictly regulated pharma&biotech field by delivering high-quality, well-designed lectures provided by engaging professionals. Joining the Academy is the simplest way to open the door to new career paths.

Rugilė Norvaišaitė

Academy student - Livija Skėrytė

It is much easier to understand what kind of field is interesting for you. Another boon of the Academy is the familiarization with the main terminology used in this type of environment, which establishes a foundation and prepares you for working in such an industry.

Gabrielius Stankus

Academy student - Katarzyna Gancarz

If you keep considering what career path might be the best for you, I advise you not to doubt and apply to the Biomapas Academy. This is a fun, risk-free way to try the industry out and see if it’s the right fit for you.

Lina Radvilaitė

Academy student - Livija Skėrytė

Biomapas Academy is a well-structured and comprehensive training program that provides valuable knowledge and practical skills for individuals interested in the pharmaceutical industry and clinical researches.

Tea Lobjanidze

Augustinas Drapeko

You may know a lot about various specific things or processes related to pharmaceuticals, but at this Academy, everything was laid out in such a clear and detailed way that you realize how much lies beyond your knowledge. It was wonderful to meet so many young, talented, and passionate professionals in their fields. Their lectures and knowledge ignited my curiosity even more, and I desire one day to become one of them.

Roberta Labokienė

Academy student - Katarzyna Gancarz

I confirm that Biomapas Academy is an excellent choice not only for someone who wants to start a career in the industry, but also for someone who is looking for a further path to valuable, solid self-development in the life science sector. I also met fantastic, motivated people. Highly recommended!

Katarzyna Gancarz

Academy student - Livija Skėrytė

I am really thankful that I had a chance to participate at Biomapas Academy. Getting the detailed information really broadened my horizons, and new connections that I made I hope will be lifelong. No doubt it was an extraordinary journey, and I wish for all the future participants to have fun just as I did.

Livija Skėrytė

Ineta Chochlovaitė

I am very grateful that I had an opportunity to participate in the Biomapas Academy. During my time in the Academy, I gained knowledge in clinical research, pharmacovigilance, regulatory affairs, and met incredible people. I feel this experience will be very beneficial for future career opportunities.

Ineta Chochlovaitė

Faez Mujeebu Rahman

 I must say I’ve got more than what I bargained for. Each lecture provided new information which enlightened me. It was definitely a fun ride. Each topic and lecturer was very well presented . I thoroughly enjoyed this journey and I hope more people give Biomapas a try.

Faez Mujeebu Rahman

I was really thrilled to be a participant in the Biomapas Academy. It was a great experience for me and a chance to learn from professionals. Many thanks to the Biomapas Team for their effort in preparing such insightful lectures.

Agnieszka Sosnicka

I truly believe that the knowledge and experience I have gained will help me grow professionally and expand new career opportunities. I really enjoyed this great Academy’s time. Thanks to the Biomapas team and lecturers who were always willing to answer all questions.

Aistė Butkevičiūtė

Augustinas Drapeko

Participating in the academy was a thrill! I learned a lot and I am positive that the knowledge I gained will help my professional future. All of the topics were presented very clearly and I found that all of the information was incredibly useful for someone pursuing the health science industry. I am incredibly grateful for the opportunity to join the Academy and broaden my knowledge of the complex pharmaceutical industry!

Augustinas Drapeko

I am very grateful for having an opportunity to meet lots of different students from other countries, learning a lot from every one of them. Biomapas Academy is a great thing that really changed my understanding of clinical trials. Thank you!

Anastasiia Moisieienko

The pharmaceutical industry is highly complex and strictly regulated. Therefore, learning directly from the passionate field professionals was an invaluable experience. I think it will be extremely useful for career mobility in the future.

Audronė Čibiraitė

Biomapas Academy was a very beneficial experience – only useful information given in a nutshell. I also could count on the immediate support and ask questions even a few weeks later. I recommend Biomapas Academy for all students and graduates who want to start their journey.

Dawid Skoczek

Biomapas Academy has undoubtedly been a great experience. I had a wonderful chance to learn from many experienced professionals and gain knowledge in different fields of the pharmaceutical industry. Surely, it will be very useful considering further developments in my career.

Ieva Lenkaitė

Studying at the Biomapas Academy allows you to expand your knowledge with research, product development, distribution, safety worldwide. The best professionals have opened the international level of pharmacological research for us. The course is very interesting and rich.

Lena Kovalchuk

I’m glad to say that this experience exceeded my expectations. To be able to learn about clinical operations, regulatory affairs and pharmacovigilance from experienced professionals is truly a unique opportunity. I am certain it will prove useful in our future careers.

Rimantė Čirvinskaitė

When I saw a post on social media about a possibility to take place in the Biomapas Academy, I signed up for it without hesitation. I was sincerely thrilled after I found out that I was selected to be one of the participants! I always desired to learn more about clinical trials, pharmacovigilance, regulatory affairs and discover my potential career opportunities.

The Biomapas Academy fulfilled what I was looking for and gave me even more. It most definitely pointed out to me where I should focus my attention to accomplish what I truly hope to. After graduating from the Academy, I can strongly advice you to participate and gain valuable knowledge and experience from many professionals. Thanks to the Biomapas team and lecturers who were always willing to help and answer all the questions!

Simona Petrauskaitė

Great chance and a lot of knowledge – this is Biomapas Academy! Learning from experienced professionals is a good opportunity to develop skills. A lot of information about Clinical Operations, Pharmacovigilance and Regulatory Affairs. I recommend it to everyone!

Magdalena Romanska

With each lecture, I became more and more motivated to gain new knowledge and delve deeper into the topics. I hope the knowledge provided by qualified specialists will be useful in the future because this project led me to take an interest in career opportunities in these fields.

Milda Bulotaitė

It’s a new way of getting more information about different pharmaceutical domains that range from research and innovation, product development, production and distribution of drug products and indeed advancement and support of healthcare directly from the members of Biomapas.

Ieva Bagdanavičiūtė

Biomapas Academy is my discovery this year. I am so happy that I could join it and meet such interesting people. I feel that all my studies have not gone in vain, and I want to expand further and adapt my knowledge and experience.

Daiva Staradumskytė

Biomapas academy has been a great experience. The academy lecturers were well prepared and were always willing to answer all questions. I got to know a lot about the pharmaceutical industry, but also I have had a great, useful and enriching time.

Austėja Šalvytė

The experience I have gained allowed me to see and learn the other side of pharma, to get to know professionals in this field who share their work experience – for this, I am very grateful. Thanks to the entire Biomapas team for this short but memorable period together.

Roberta Dagilienė

Biomapas Academy

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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.
Affiliate-Based Outsourcing
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M&A Support

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