Biomapas Bulletin – Fifth Edition
In the midst of the summer season, we are back with the fifth edition of the Biomapas Bulletin! This month, we toast to and reflect on a decade of success in our Georgia office.??
We set our sails to BIX South Korea, bringing back insights from the dynamic world of biotech. In addition, delving into our latest webinar on Medical Information (MI) and Pharmacovigilance (PV) technologies, and an insightful whitepaper on Computerised System Validation (CSV) and PV processes.??
We wrap up this issue with another celebration for Interns Day and a peek into our internal life at Biomapas.
Biomapas Celebrates 10 Years of Success in Georgia!?
In 2014, we embarked on an exciting venture by establishing our first office in the capital, Tbilisi. Since then, our Georgia team has grown from a handful of individuals to a thriving community. Just last year, we reached another milestone with the opening of our new office space, further solidifying our presence in Georgia's clinical landscape.?
Georgia has played an instrumental role in advancing clinical trials across various therapeutic areas, including oncology, cardiovascular, and neurological disorders. The country's unique location at the crossroads of Eastern Europe and Western Asia, combined with its favourable regulatory environment, has made it an attractive destination for international sponsors seeking to conduct innovative research projects.?
The country offers several advantages for conducting clinical trials, including an efficient regulatory approval process, large patient populations across diverse therapeutic areas, and skilled medical personnel well-equipped to support clinical research initiatives.?
As we reflect on this remarkable 10-year journey, Tamar Chirgadze , our Director of Biomapas Georgia and Senior Clinical Operations Manager in Tbilisi, shared:??
"I am filled with huge gratitude to mark this momentous occasion of our Georgia office. Ten years ago, our company took the bold step of establishing its first office in Tbilisi, and today, we stand as a thriving community of dedicated professionals. I am thrilled to have joined the incredible team in 2022 and be a part of this remarkable journey.?
"Georgia has played an essential role in clinical trials with more than 400 international multicentre trials conducted since 1997. Given our country's population, we have been fortunate to provide researchers with access to a diverse patients pool, boosting enrolment and fostering a robust clinical trial environment.?
"As we celebrate this 10th anniversary, I would like to extend my sincerest appreciation to all our colleagues in Georgia for their unwavering dedication and hard work. I am proud to work alongside such a talented, strong, and successful team of dedicated professionals who share a commitment to quality and success.?
"It is a privilege to be part of this esteemed organisation, and I extend my best wishes to our team for continued growth, achievements, and development!"?
To learn more about clinical trials and our work in Georgia, why not delve into our recent case study: Specialised Rescue Studies.pdf
Global Engagements?
The summer has brought about some quiet time in the global conference sphere, but before taking on the holiday season, we head to South Korea.?
BIOPLUS-INTERPHEX KOREA (BIX) – 10-12th July in Seoul, South Korea?
July was a big leap through the globe for our CEO, János Filakovsky , who participated at BIOPLUS-INTERPHEX KOREA (BIX) in Seoul, South Korea. The pharmaceutical exhibition encompasses the biopharmaceutical value chain, and advanced technologies, offering ways for both local South Korean and international CROs and biotech companies, to expand overseas by building global business networks.?
János joined the panel ‘Regulatory Affairs for Clinical Trials in Europe’, exploring Europe’s competitive advantages, new regulations, and financial incentives. As South Korea is increasingly expanding to the European/EU market, there was plenty to discuss, including the region’s advanced clinical trial infrastructure and reasonable costs.? ?
János talked about harmonised clinical trial approval processes in the EU, and Biomapas’ experience?navigating the new Clinical Trials Information System (CTIS). They discussed individual start-up strategies, rapid patient enrolment,?and collaborations with Korean Biotechs, along with the cultural differences between Asia-Pacific and Europe.?
Given the local companies' focus on cell & gene therapies, there was keen interest in the role of central laboratories, CDMOs and regulatory environment in Europe. These hubs are crucial for clinical research by providing standardised and high-quality laboratory services across multiple study sites and ensuring consistency and reliability of data.?
South Korean companies were particularly interested in the single-country and multi-country clinical trials regulatory approval and study start-up strategy.?
János also met with several South Korean companies, including ROKIT HEALTHCARE , which specialises in hyper-personalised organ regenerative healthcare solutions; KMDBio, known for developing innovative new drugs for diseases with high unmet medical needs through technology convergence; and MediRama Inc. , which provides comprehensive clinical and business development services, particularly in clinical oncology and drug development, aiming for regulatory approvals like NDA/BLA.?
We appreciate the warm welcome from each of these companies and look forward to exploring collaborative and innovative opportunities in the biotechnology industry.?
At Biomapas, we seek to be your gateway to Europe’s clinical, regulatory, and pharmacovigilance landscape. Our teams have comprehensive expertise and assure quality and accuracy for all our activities across Europe and globally. To learn more about our services, visit: https://www.biomapas.com/?
领英推荐
Insightful Reads?
Explore our latest whitepaper on Computerised System Validation (CSV) & Pharmacovigilance (PV), and gain insights into optimised CSV solutions, and their role in effective risk management.? ?
Key Highlights:?
At Biomapas, we adhere to regulatory guidelines and industry best practices to execute thorough validation strategies, guaranteeing the highest standards of data integrity, accuracy, and patient safety.? ?
Ready to enhance your drug safety and compliance strategies?: Whitepaper: Computerised System Validation and Pharmacovigilance.pdf_July2024
Webinar: Breaking Silos Across Medical Information & Pharmacovigilance?
During this insightful session, we explored how technology can optimise Medical Information & Pharmacovigilance processes to enhance efficiency and collaboration. ?
Olga Asimaki, PhD, CMD , Head of Global Medical Information, and Martijn van de Leur , Chief Operating Officer, guided us through examples of a Single Source of Truth (SSOT) PV/MI System, including handling Adverse Events, Product Quality Complaints, and MI inquiries.? ?
Watch the recording and learn how to enhance your PV/MI operational efficiency: https://lnkd.in/ePJwHzay??
Looking for a deep dive? Read our whitepaper on the topic: https://lnkd.in/dRMC9NV8?
Interns in the Spotlight?
Shoutout to all our current and past interns at Biomapas – this month we celebrate their success! Over the years, we had the privilege of working with many brilliant young talents, some of whom stayed with us and continued their career journeys. ? ?
At Biomapas, we offer high-quality internships in areas ranging from Clinical Research to Business Development and beyond. Our practice-oriented activities give interns the chance to tackle real-life problems and collaborate on innovative ideas.?
We pride ourselves on our flexibility, offering opportunities for interns to explore different roles and departments. ? ?
Discover more about our internship opportunities at: Internships - Biomapas
And, read what our interns say about working at Biomapas: https://www.dhirubhai.net/posts/biomapas-clinical-regulatory-pharmacovigilance_nartionalinternday-pharmajobs-internships-activity-7222158826093907969-SIMm?utm_source=share&utm_medium=member_desktop?
Biomapas’s Lively Internal Initiatives?
Bites & Insights?
As part of our Bites & Insights tradition, we spent one sunny July morning having some informal conversation with our team of executives, accompanied by a delicious selection of baked goods. These periodic breakfasts are deeply ingrained in our company culture, as we seek to stay aligned throughout our entire organisation and deepen our relationships with one another.?
This time around our curious colleagues had a chance to ask the management team any burning questions they had about our people, goals, partnerships, and beyond. Of course, there was some time and space for more casual topics, so we chatted away about our summer vacation plans, travel ideas, and a couple of upcoming events, such as the Vilnius marathon and velomarathon later this summer.?
Explore our company values at: About Us
Thank you for being part of our journey, we are excited to share more updates, insights, and exciting developments – until next time, we keep innovating, collaborating, and making a positive impact in the world of healthcare!?