How did you decide to participate in the Biomapas Academy?
When I used to walk past a pharmacy every day, I could never stop dreaming about being able to help people and develop innovative pharmaceuticals. So while studying biomedical sciences, I became interested in the drug development paths, which led me to medicinal chemistry. And one day at the university, I saw a poster about the Biomapas Academy, which could help me understand what, how, where, and when happens to pharmaceutical products during the whole journey to reach us, so I signed up for it without hesitation. Even though I am usually not a lucky person, I was selected to be one of the participants, which surprised me!
How was your experience regarding the Academy?
During the few months, I deepened my existing knowledge of drug development stages and expanded it to learn more about drug regulation and pharmacovigilance. After graduating from the Academy, I got the opportunity to try out regulatory affairs as part of Biomapas – I completed a summer internship in the Regulatory Affairs department.
How do you feel after graduating from the Academy?
I will never forget this practice in my life, not only because it fulfilled what I was looking for, but it let me realize that I want to return to this company after my graduation and put my accumulated knowledge to use. Thanks again to all Biomapas staff for their insights and advice, and I hope to see you soon.
Biomapas Academy
What is Clinical Research? Regulatory Affairs? Pharmacovigilance?
3 Factors Affecting the Successful Collection of Drug Safety Information in Social Networking Sites
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...
Drugs serialization and barcoding in Saudi Arabia and MENA region
An increasing number of countries worldwide have enacted regulations mandating serialization, tracking and tracing of pharmaceutical products down the supply chain during recent years as a response to drug integrity concerns. There are plenty of laws requiring...
eCTD implementation across MENA region: What is the current status?
As the electronic Common Technical Document (eCTD) became the standard for submitting Regulatory Information to leading agencies worldwide, its adoption still poses a considerable challenge for those agencies who lack the needed human and/or material resources. How is...
Building Health Literacy: The Value of Good Writing
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 endanger the health and life of a patient. Thus, the main goal in medical writing is to convey the message clearly and concisely to avoid misinterpretation.
CMC: Down the road in effective IND/IMPD writing
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.
European Union Funding/Europos Sajungos parama
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.
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.
