Biomapas Bulletin – Third Edition
With summer making its entrance in the Northern Hemisphere, May has been marked by an exciting array of events and industry engagements. From the bustling streets of London to the vibrant city of Barcelona, our teams have been actively participating in global conferences, sharing expertise and insights.?
To start this month’s edition, we dive right into our latest whitepaper on breaking silos across Pharmacovigilance (PV) and Medical Information (MI) processes; in addition to visiting Tashkent to explore the clinical research landscape of Uzbekistan.?
We discuss the highlights of the May conference season and celebrate International Clinical Trials Day. Wrapping up, we recap our annual ‘Global Event: Let’s Celebrate Success!’ and bid farewell to the fifth edition of the Biomapas Academy!?
Food for Thought – Delve into our Latest Whitepaper!?
In this comprehensive whitepaper we explore the implementation and benefits of Pharmacovigilance (PV) and Medical Information (MI) processes following a Single Source of Truth (SSOT) framework for (Bio)pharmaceutical companies.?
Regulatory requirements demand continuous monitoring of drug safety profiles, making robust PV/MI systems essential for capturing, analysing, and reporting Adverse Events (AEs) and Product Quality Complaints (PQCs). These processes not only enhance patient safety and regulatory compliance, but greatly support operational efficiency.?
We address the challenges of managing diverse data streams, exploring a cloud-based, omnichannel database solution. This system centralises the intake and management of MI, AE, and PQC data, eliminating external tools and boosting efficiency through automation and real-time insights. Some of the key benefits include increased efficiency in query handling, improved data integrity, significant reductions in compliance errors and non-conformities, and enhanced productivity.?
Ready to transform your PV/MI processes? Read the full whitepaper and begin your journey towards operational excellence: https://lnkd.in/dRMC9NV8 ?
Global Engagements?
Biomapas is expanding its horizons in Uzbekistan!???
Recently, our Co-founder & Chairman of the Board, Audrius Sveikata , and CEO, János Filakovsky , visited the Uzbek capital of Tashkent to explore the region’s clinical research landscape and culture.??
The pharmaceutical industry in Uzbekistan is one of the most rapidly developing in the CIS and Central Asia regions. According to Statista, the projected revenue in 2024 is expected to reach US$429.50m, with oncology drugs projected to have a market volume of US$58.64m in the same year. The region also boasts a large population of 35 million and short approval timelines, making it an ideal location for pharmaceutical investment and clinical trials.??
Audrius and János were welcomed by the Centre for Pharmaceutical Products Safety, the Republican Specialised Scientific-Practical Medical Centre of Oncology and Radiology, the Tashkent Medical Academy (TMA), and a local medical affiliate.??
The Centre for Pharmaceutical Products Safety, under the Ministry of Health in Uzbekistan, regulates the safety, certification, and quality control of pharmaceutical products. Here, our Biomapas duo met the Director of the Centre and the Deputy Directors.??
The aim of the visit was to understand the regulatory clinical requirements in the country, and the timelines and documentation required to conduct trials. While some aspects are still under development, there is a great passion and openness to attract sponsors and investors, and a regulatory ecosystem ready to serve the global market in line with the international standards, such as the International Conference on Harmonisation Good Clinical Practice (ICH GCP) framework being introduced in recent years.??
Audrius and János also met with the Executives, Head of Oncology, and Deputy Directors at the Republican Specialised Scientific-Practical Medical Centre of Oncology and Radiology. The Centre has extensive connections throughout Uzbekistan, providing operational guidance and support to 15 additional oncology partner hospitals, with the network reaching 70,000 patients annually.??
The Tashkent Medical Academy (TMA) Clinics and Medical Centres invited them for a tour of their facilities, where they met with the Clinical Director of the TMA and the Heads of Neurology, Nephrology, and Rheumatology. TMA offers multidisciplinary medical care to international standards, specialising in therapeutic treatments for both adults and children across over 20 fields.??
Finally, through their trip in the Uzbek capital, Audrius and János facilitated discussions with a local medical distributor company in order to learn more about the specific practicalities of clinical research and regulations from a local point of view.??
Within this fully packed schedule, they also managed to find some time to explore Tashkent's and Samarkand’s historic highlights and culinary scene.??
Reflecting on the visit, Audrius said: "It was a pleasure to meet so many dedicated leaders and professionals! Uzbekistan’s rapidly evolving pharmaceutical market presents unparalleled opportunities for innovation and collaboration. This visit has reinforced Biomapas’s commitment to advancing clinical research in this dynamic region."??
János remarked: "The warm welcome and collaborative spirit we experienced in Tashkent highlight the region's readiness to become a prominent centre of the global multinational clinical trials sphere.?A massive thank you for all the individuals and organisations involved!"??
Pharmacovigilance Europe – London, United Kingdom???
This May one of our many PV experts, Artemis Thanasopoulou , and EU BD, Deni Christov spotlighted Biomapas’s expertise in Global Pharmacovigilance and the complexities of global QPPV processes in London. The event attracted a targeted audience and featured engaging presentations, and insightful case studies on audits, inspections, and AI-driven efficiency solutions.?
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Artemis also joined the speaker’s lineup, with her presentation, titled: 'The Role of International Pharmacovigilance in Shaping Global QPPV Offices,' covering:?
On the same day, Artemis got to shine even brighter, when she was honoured with the Platinum Award of Biomapas’s Reward and Recognition programme, presented by CEO, János Filakovsky . This annual award highlights Artemis’s exceptional contributions, outstanding performance under pressure, innovative solutions, and significant long-term project achievements.?
OCT Europe – Barcelona, Spain?
Deni Christov and Marco Della Mura had an outstanding time at his year’s conference, covering themes such as clinical operations and outsourcing, sponsors’ preferences when selecting a CRO, effective collaboration and long-term relationships with sites and partners, as well as trial execution and cost management amidst inflation.?
Deni and Marco joined an insightful session on Clinical Technology and Innovation, which explored how AI and other technological advancements can enhance trial execution and clinical trial conduct. The discussion also addressed patient centricity, including patient engagement, recruitment challenges, and solutions.?
Upcoming Events & Conferences?
As you read this newsletter, our teams are likely en route to their next destinations. June is kicking off with two major conferences on the West Coast, while others will have the pleasure of networking under the Italian sun:?
Celebrating International Clinical Trials Day (ICTD)?
ICTD recognises and celebrates the achievements of modern clinical research, providing an opportunity for research organisations, clinical research professionals, and the public to discuss various aspects of trials. To mark this special day, our clinical experts, Irma U. ?inskien?, Arturas Pazera , Monika Kapaciune , and Simona Misevi?iūt? , shared some insights into the importance of the field and the reason behind their chosen career paths.?
Read all about their experience here: https://www.dhirubhai.net/feed/update/urn:li:activity:7198302531465158658 ?
Biomapas’s Lively Internal Initiatives?
Reflecting & Celebrating: Annual Global Event?
Not a month goes by without a fully packed internal agenda, but we have to say May has been especially exciting with holding our ‘Global Event: Let’s celebrate success!’ in our Kaunas HQ.?
This annual event serves as a time to reflect on the past year and celebrate our company’s achievements, focusing on colleagues’ successes, long-term work anniversaries, the successful integration of newcomers, and promotions, with 17% of our employees promoted this year.??
We also use this opportunity to share important updates, insights, and best practices within our departments and the life sciences industry. Later in the evening, we let our hair loose and enjoyed some dancing to some traditional Lithuanian bops!?
Empowering Young Professionals in Life Sciences?
On another note, the fifth edition of the Biomapas Academy has come to an end, and while it’s sad to say goodbye for now, we are excited to see how the future of these young minds will turn out!?
In case you are not familiar with the programme, Biomapas Academy is a multidisciplinary initiative designed to introduce students and recent graduates to Clinical Research, Regulatory Affairs, Pharmacovigilance, and Medical Information. Recognising that many students are unaware of career opportunities in these fields, we created this programme to help aspiring professionals discover the often-hidden career paths within life sciences.??
During the past three months these young specialists had the chance to explore new possibilities and realise their calling in various fields. We are incredibly proud of the dozen participants who have taken significant steps toward their dreams and aspirations in the life sciences industry!?
Want to know more? Read about their reflections on the Academy here: https://www.dhirubhai.net/feed/update/urn:li:activity:7193533883865300992 ?
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!?