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?
Webinar: Effective IMPD Writing. The Quality Part
Effective IMPD writing, including the quality part is a vital document that contains information about an investigational medicinal product and it is an essential part of the Clinical Trial Application (CTA), which is required by competent authorities in EU. The...
Clinical Study Start-Up: Is there any Difference Between Western and Eastern Europe?
This article reviews Clinical Study Start-up Differences Between West & East Europe, timelines, and processes. Medicine is constantly evolving to invent effective ways to treat diseases. This progress is a never-ending process: the life science industry develops...
Expediting access through Reliance Pathways: MENA region
Reliance models are review pathways used by Regulators to expedite the patient access to essential pharmaceutical products and to overcome resource constraints and priorities. Recently, several National Competent Authorities (NCA) in the Middle East North Africa (MENA) region have implemented the Abridged and Verification reviews. These regulatory procedures allow the approvement of needed innovative and/or life-saving drugs.
Webinar: eCTD Submission Strategies. In-house vs. Outsourcing
eCTD Submission Strategies, including outsourcing, are influenced by varying requirements in various regions and countries. That and diverse technical resources by companies often lead to various regulatory strategies. Thus, the questions arises: how to choose the...
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.
