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3 Factors Affecting the Successful Collection of Drug Safety Information in Social Networking Sites

By | news1

Health information that has been posted online by patients can efficiently supplement your post-marketing drug safety data gained from traditional sources. Data harvesting from Social Networking Sites (SNS) has a lot of potential and significant advantages when compared to traditional sources. One of the main benefits is the near real-time monitoring of Adverse Drug Reactions.

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Migle Janeliuniene

Building Health Literacy: The Value of Good Writing

By | news1

Scientists, doctors, and health authorities often use written communication to present their research, opinions, or guidelines to the patients. While the questions they approach may be complex, the language should not. In medical documents, misinterpreted information may even endanger the health and life of a patient. Thus, the main goal in medical writing, as in any writing, is to convey the message clearly and concisely.

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CMC: Down the road in effective IND/IMPD writing

By | news1

In the previous two articles, we have shared our experience on various aspects of effective IND/IMPD CMC writing, considering proper planning, assigning a dedicated CMC writing team, and having effective project management. In addition, we discussed technical writing particulars giving some key messages on document preparation. Now, we will discuss other important points. These are safety, data completeness, and geographical regions.

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European Union Funding/Europos Sajungos parama

By | news1

In July 2020 Biomapas started an EU funded project of research and development activities by creating an artificial intelligence (AI) tool for pharmacovigilance services. The main aim of the project – to create a pharmacovigilance system based on artificial intelligence. Biomapas plans to commercialize the prototype of the technology created during the project in the form of a new pharmacovigilance service which will ensure continuous improvement of drug safety.

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Proper Publicizing in CEECs – Path to Successful Social Media Commercials

By | news1

With the growth of social media network users all over the world, there is no doubt that one of the most accessible and 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 (7). Therefore, since medical devices and over-the-counter medicines are being more and more often promoter by commercials on social media nowadays, there is greater risk of hidden or misleading advertisements (1).

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Igne Pleskute, MPharm Regulatory Affairs Specialist Biomapas

How Mergers and Acquisitions of Pharma Companies affect Regulatory Affairs?

By | news1

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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Ada Stelmakiene, MPharm, PhD Senior Pharmacovigilance Specialist (EU-QPPV) Biomapas

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

By | news1

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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Ineta Šumskienė, MSc Manager Clinical Operations Biomapas

Clinical Study Start-up: Is there any Difference Between Western and Eastern Europe?

By | news1

Medicine is constantly evolving to invent effective ways to treat diseases. This progress is a never-ending process: life science industry develops new molecules and treatments and improves existing ones continually. Experimentation and testing have long been a part of medicine, and it is up until now as clinical trials have an essential part in the development of new treatments. These reasons allow us to assume that the relevance of clinical trials will not diminish in the future.

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Ramune Rukiene, MSc Director Regulatory Affairs Biomapas

CMC: Effective Writing of IND and IMPD

By | news1

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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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.

Biomapas appoints Head of Global Regulatory Affairs

By | news1

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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