Why did you decide to participate in the Biomapas Academy?
The first time I heard about Biomapas Academy was from a friend who was already working in the pharmacy field. She sent me an advertisement for Biomapas Academy, which highly intrigued me. As I was in my last year of life science master studies, I wanted to discover my potential career possibilities and learn more about clinical trials. Therefore, without long thinking, I filled in the application form. I was very happy to be selected from quite many applicants and be invited to attend Biomapas Academy.
How was your experience during the three months?
We had four months of weekly lectures on different topics. They were related to the organization of clinical trials, regulatory affairs and pharmacovigilance of various medical products. Biomapas experts who resented the lectures even shared their personal experience and actual practical examples with us. We have been able to get acquainted with Biomapas company and its work specifics. Here we could expand our knowledge of the pharmaceutical industry.
How do you feel after graduating from the Academy?
I feel thrilled for taking a chance to participate in this unique project. After graduating from all the courses and tasks, I was absolutely honoured to be selected as the best student of Biomapas Academy 2020 and receive a scholarship. However, I mostly appreciate the valuable knowledge and experience I believe will be helpful for my future career. I think Biomapas Academy definitely contributes to the education of young professionals and is very useful, especially for those who want to get to know their professional opportunities better.
Biomapas Academy
What is Clinical Research? Regulatory Affairs? Pharmacovigilance?
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.
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...
