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?
Edita Kaupienė – Senior Pharmacovigilance Project Manager
Explore how Edita’s role supports pharmacovigilance project planning and execution, from strategy to everyday operations.
Megi Muradashvili – Senior Clinical Research Associate
What is your role at Biomapas? My role is Senior Clinical research associate. I am mainly responsible for overseeing clinical trials and their performance in strict accordance with the protocol, ICH-GCP requirements, and standard operating procedures (SOPs) for...
Saudi FDA’s New Pricing Guidelines and Impact on the Region
In a highly evolving regional pricing environment, Saudi Arabia (KSA) is no exception. The Saudi Food and Drug Authority (SFDA) has been periodically reviewing its pricing mechanisms and criteria so that the country becomes a regional reference for the prices of pharmaceutical products. What followed is a change in the pricing strategy by SFDA and a shift from price takers to price makers.
Marketing pharmaceutical products in CIS countries / Eurasion Union
The interest of pharmaceutical companies in expanding business across CIS region has been constantly growing. For the same reason, Biomapas has expanded presence and now covers the whole CIS region, providing core services: clinical research, regulatory affairs,...
Webinar: Regulatory Strategy in the EAEU and Rest of CIS Countries
Regulatory strategy in EAEU and CIS regions differ from other regions as market access to these countries can be a real challenge due to various local regulations. However, it is only a matter of experience and adequate know-how. This webinar focuses on choosing your...
CMC: Effective Writing Of IND And IMPD
This artical focuses on best practices in delivering an effective CMC writing strategy when writing an IND or IMPD.
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...
