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?
7 Reasons To Include Eastern Europe In Your Clinical Trial Strategy
Choosing the right set of countries, sites and investigators for a clinical trial are critical success factors in any clinical development program. They can guarantee speedy patient recruitment and timely delivery of study results. It also ensures that you conduct...
Company Registration Requirements in MENA: a Prerequisite for Product Registration
Company registration is part of the common regulatory requirements in several Middle Eastern and North African (MENA) countries. Nevertheless, it can be easily overlooked in preparation for drug filing and the overall regulatory picture. MENA countries are accepting...
Biosimilars in the MENA Region: Regulatory Landscape
Regulatory affairs for biosimilars in Middle East North Africa (MENA) region are evolving as existing guidelines and regulatory frameworks are being updated. Since European Medicines Agency (EMA) introduced a legal pathway for biosimilars approval in 2004, several...
Successful Medical Device Registration in EAEU: New Legislation (Part 1)
Webinar: Successful Medical Device Registration in EAEU: New Legislation (Part 1) The webinar discusses and explains the basic, essential, and theoretical matters of the EAEU system, outlines the new approach to the quality, safety, and efficacy assessments, and...
Inga Lakštauskienė – Head of Global Regulatory Affairs Operations
Learn about Inga’s role in managing our regulatory affairs team and coordinating various regulatory projects.
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.
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.
