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?
Preparing for Affiliate-Based Outsourcing for Regulatory Affairs
Affiliate-Based Outsourcing (ABO) model for regulatory affairs works as a replacement or an extension of the company's internal local regulatory resources, which often do not fully fulfil the needs for the effective organization, flexible resources, business...
Drug Registration in the Eurasian Economic Union (EAEU)
Drug registration in the EAEU: Learn about pathways for market authorization, the CTD format, and approvals in the Eurasian Economic Union.
Marketing Authorization Renewal in the MENA Region
Regulatory Authorities across the MENA region indicate a specific validity period for the Marketing Authorization Approval certificate of pharmaceutical products that ranges between four to five years in most countries. The purpose behind this license validity period...
How to register a Medical Device in the EAEU
Since the establishment of the Eurasian Economic Union in 2015, a significant change is quickly coming into life: a new regional registration system for medical devices is coming into effect from the start of 2022. As most registrations are completed through national...
How to prepare for Affiliate-Based Outsourcing for Regulatory Affairs?
Webinar: How to prepare for Affiliate-Based Outsourcing for Regulatory Affairs? Affiliate-Based Outsourcing (ABO) Model for Regulatory Affairs works as a replacement or an extension of the company's internal and local RA resources, which are often insufficient for the...
Setting Up A Pharmacovigilance System
Setting Up a Pharmacovigilance System from Scratch In the EU/EEA, US, and other major pharmaceutical markets, you need a sound plan for post-market surveillance for your medicinal product's Market Authorization Application (MAA). A robust pharmacovigilance (PV) system...
Centralized Procedure in the GCC Region
The Centralized Procedure in the GCC Region describes the possibility to register pharmaceutical products throughout the region. The Cooperation Council for the Arab States of the Gulf, abbreviated as "GCC" for "Gulf Cooperation Council", came to exist on May 25th,...
Must-Know Legislation for Medical Device Registration in the EAEU
EAEU legislation for Medical Device registration has been continuously updating for the last six years since the Eurasian Economic Union, otherwise known as EAEU, was entered into force in 2015. Five countries have signed the "Treaty on the Eurasian Economic Union" to...
Strategic Pharmacovigilance Outsourcing Models
Larger companies often limit their strategic pharmacovigilance activities outsourcing only to highly manual and repetitive tasks, while the smaller ones may want to outsource their entire pharmacovigilance system. But is there anything in between? How can larger...
Medical Device Registration in the Eurasian Economic Union (EAEU)(Part 2)
How do you realize Medical Device Registration in the Eurasian Economic Union (EAEU)? Learn about EAEU Conformity Assessment Routes and MRP.
