How did you decide to participate in the Biomapas Academy?
The first thing that caught my attention was the Biomapas Academy poster hanging on my university’s bulletin board. Shortly afterwards, the faculty management shared Biomapas’ invitation to register for the first Biomapas Academy. I wanted to learn more about this company, so I decided to take my chances and apply to the Academy. I was thrilled when I received a call with the happy news that I had successfully passed the selection process and was invited to attend the Academy.
What was your experience during the three months?
I listened to many interesting lectures, during which we got to know the company and its areas of activity. We listened to lectures on clinical trials and their organization, pharmacovigilance, regulatory affairs, bioethics, drug registration, and more. I believe that the knowledge gained at the Academy is valuable and helpful for all participants of the Academy and their future careers.
What did the future hold for you after the Academy?
I mainly was interested in pharmacovigilance, so we agreed on an internship in this department during the summer. Interesting fact: the first Biomapas poster I saw was about pharmacovigilance! And the best thing is that after the internship, I was able to join and become a part of this great team. I am happy to be here and to learn from real professionals in this field.
What would you say to the future participants?
I want to encourage everyone who is thinking about participating in the Biomapas Academy. Being at the Academy is exciting and worthwhile. By joining the Academy, you will broaden your horizons, learn from global professionals, improve your life sciences knowledge, and gain valuable experience. I wish good luck to all participants. See you soon at Biomapas!
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...
