Phortas

📣 We are proud to announce that Dr. Darius-Jean Namdjou, our Director, Senior Regulatory Lead at Phortas will be presenting at 'Clinical Partnership and Outsourcing' conference in London, from 08-09 Oct 2024. This opportunity highlights our commitment to excellence and our dedication to advancing industry standards through knowledge sharing and collaboration. #regulatoryaffairs #biotech #drugdevelopment

🗨 𝗧𝗲𝘀𝘁𝗶𝗺𝗼𝗻𝗶𝗮𝗹 𝗧𝘂𝗲𝘀𝗱𝗮𝘆 EU-X-CT thrives because of our passionate volunteers. Their commitment drives our mission to improve cross-border access to clinical trials Thank you Dr. Darius-Jean Namdjou for your involvement in the EU-X-CT project. 🔗 𝗠𝗼𝗿𝗲 𝗮𝗯𝗼𝘂𝘁 𝗘𝗨-𝗫-𝗖𝗧: https://eu-x-ct.eu/ #TestimonialTuesday #EUXCT #CrossBorderTrials #ClinicalTrials

Phortas is growing! We are excited to announce a new entry-level position in our Regulatory Affairs department! No previous industry experience is required—bring your passion for the pharmaceutical Regulatory Affairs field and eagerness to learn, and we'll provide the rest. Apply here: https://lnkd.in/dvmmM3G #regulatoryaffairs #job #pharmaceuticalindustry #biotech

On this coming Friday, 14 June 2024, our Managing Director, Jasmina Savic, will be travelling to the EMA’s Amsterdam office to join in person the Joint HMA/EMA workshop on real-world evidence (RWE) methods. Real-world data play a crucial role in fully understanding the efficacy and safety of medicines and will become even more significant as records from standard clinical practice continue to be captured electronically. This Workshop will be discussing the use of RWE in regulatory decisions making, from non-interventional studies to  use of real-world data as external controls in clinical trials to support marketing authorizations. Phortas has gained significant experience with use of RWE in our Clients’ development and post-approval programs and we are happy to discuss next steps with the European key stakeholders. #europeanmedicinesagency #pharmaceuticals #pharmaindustry #FDA #realworlddata #bigdata #innovation #drugdevelopment

New medicines reach market much later or in some cases don’t reach the market at all, if the Regulatory Affairs approach isn’t aligned with the scientific and medicinal effort invested in developing your product. Even experienced biotech and pharmaceutical companies can be caught off guard by regulatory issues, opportunities, and risks. Carefully crafted Regulatory strategy is a result of experience, planning, interaction with authorities and deep understanding of the regulatory risks and opportunities. Effective regulatory strategy is a team effort. Let’s work together to craft yours. 📩 [email protected] #regulatoryaffairs #biotech #pharmaceutical #clinicaldevelopment #clinicaltrials #drugdevelopment #regulatorystrategy

On May 10th, 2024, the German regulator "Federal Institute for Drugs and Medical Devices (BfArM)" introduced a new informal exchange format focused on topics concerning Clinical Research. Dr. Darius-Jean Namdjou - Director, Senior Regulatory Lead from Phortas attended this event. BfArM demonstrated its commitment to open communication with industry stakeholders, including Contract Research Organizations (CROs), consultants, academics, and others, with significant participation from senior staff in the clinical trial evaluation area. Key takeaways from the event include: 💡 EU Clinical Trial Regulation (EU CTR) Transition: Over 1,000 companies still need to transition their trials to comply with the EU CTR, with the final deadline approaching. BfArM offers a 20-day transition period for complete applications. 💡Meeting Formats: The new pre-Clinical Trial Application (pre-CTA) meeting format allows discussion of specific Clinical Trial Applications with BfArM and the responsible Ethics Committee before EU CTR submission, proving to be a valuable tool. 💡EU CTR Part II: Although BfArM is not responsible for EU CTR Part II documents, the MedEthics EU Forum has been mandated to work on harmonizing these requirements as much as possible. At Phortas, we bring extensive experience in submissions under the EU CTR/CTIS and the new pre-CTA meeting format of BfArM. We're always ready to support industry initiatives with our expertise. 📧 [email protected] #regulatoryaffairs #ctis #drugdevelopment #clinicaltrials #biotech

Happy Clinical Trials Day! 🔬 At Phortas, we celebrate the incredible advancements and unwavering dedication that clinical trials bring to the world of healthcare. Today, we honor the researchers, patients, participants, and professionals who work tirelessly to transform innovative ideas into life-saving treatments. Clinical trials are the cornerstone of medical progress, ensuring new therapies are safe and effective. They embody the spirit of collaboration, scientific rigor, and hope for a healthier future. As a leading consultancy in Regulatory Affairs and Drug Development, Phortas is proud to support these vital efforts, helping to guide clinical research and bring new therapies to those in need. Thank you to everyone involved in this noble pursuit, especially the patients who make these advancements possible. Let's continue to push the boundaries of science and improve lives globally. #ClinicalTrialsDay #ClinicalResearch #DrugDevelopment #Phortas #RegulatoryAffairs #MedicalInnovation #HealthcareAdvancement #regulatoryaffairs #research #biotech #pharmaceuticalindustry

🌟 Meet Jasmina Savic, Our Founder and Managing Director at Phortas! 🌟 Thrilled to introduce you to the powerhouse behind Phortas, Jasmina Savic! With a background in pharmacy and a post-graduate degree in Regulatory Affairs, Jasmina brings over 17 years of invaluable experience to the table. Her journey encompasses diverse roles across all phases of pharmaceutical development, spanning numerous therapeutic areas. Jasmina has demonstrated exceptional management skills in various high-level Regulatory Affairs positions. Jasmina has extensive experience with Regulatory agencies across the globe, including FDA, EMA, PMDA, and national agencies. Her adeptness in navigating regulatory requirements has been integral to the success of Phortas and its clients. As a true entrepreneurial spirit, Jasmina created a team of Regulatory and Drug Development professionals from scratch, showcasing her vision and determination. Under her leadership, Phortas has risen to become one of the leading Regulatory Affairs and Drug Development consultancies, setting the standard for excellence in the industry. 🚀 Jasmina's guidance has been instrumental in bringing various drugs, biologics, and orphan drugs to the market, improving patient access to life-changing treatments. Join us in congratulating Jasmina on her remarkable achievements! 🎉 #Phortas #RegulatoryAffairs #LeadershipExcellence #MeetTheTeam #drugdevelopment #pharmaceuticalindustry #biotech #entrepreneurship

🌟 Exciting Moments from RAPS Euro Convergence! 🌟 Yesterday, our Managing Director Jasmina Savic took the stage at RAPS Euro Convergence in Berlin, presenting an insightful session titled "Meeting EMA and FDA: Formal and Informal Pathways in Search of Alignment." The session was followed by comments and questions from the industry professionals and regulators. #RAPSEUROconvergence this year was a total success! 🎉 🎯 Thanks to Regulatory Affairs Professionals Society (RAPS) for such an amazing event and for giving us the opportunity to contribute to the regulatory affairs body of knowledge. #regualtoryaffairs #biotech #pharmaceuticalindustry #drugdevelopment #clinicaltrials

📢 Exciting news from Phortas as we gear up for the Regulatory Affairs Professionals Society (RAPS) Euro Convergence in Berlin next week! We're thrilled to announce that our Managing Director, Jasmina Savic, will be sharing her insights on the crucial topic of "Meeting EMA and FDA: Formal and informal pathways, in search of alignment." 💡 Additionally, our Senior Regulatory Expert, Irena Milobratovic, will be presenting "Rethinking Expedited Drug Development Program Opportunities & Challenges in the EU & US." 📊 We look forward to engaging with industry peers, including the Head of Scientific Advice from the EMA and our esteemed colleagues from Arriello. It’s a fantastic opportunity to exchange ideas, strategies, and experiences that drive our industry forward. 🤝 Join us in Berlin for what promises to be a series of insightful discussions and valuable networking. See you there! 📍 #RAPS2024 #pharmaceuticals #regulatoryaffairs #drugdevelopment #networking