MAIN5’s Post

✴ We are at TOPRA - The Organisation for Professionals in Regulatory Affairs Symposium 2024! Our experts Katharina Mayer, Melita Luša, Piotr Wierzchowski, Marjeta Panjan Žalec, and Managing Partner Tore Bergsteiner enjoyed a great first day in Rotterdam, exploring the latest trends and innovations in regulatory affairs. Visit us at #booth26 and discuss how MAIN5 can support your organization navigating the complexities of regulatory affairs with our tailor-made solutions. 🤝 Let's connect! #TOPRA #MAIN5 #Regulatory #LifeSciences #Networking

👋 Meet us in Paris! Our colleagues Sarra Othmani, Nenad Čajko and Christine Hirt had a great first day at the Ennov User Meeting 2024 networking with other professionals in the field, enjoying great conversations, attending insightful presentations and exploring the latest innovations in Ennov products. 🤝 If you are attending, don't miss the chance and connect with Sarra, Christine and Nenad. Discuss the latest industry trends, and discover how MAIN5 can support your organization's journey to excellence. 👋 Let's connect! #MAIN5 #EnnovUserMeeting2024 #Networking #Innovation #Regulatory #LifeSciences

👋 We’re excited to welcome Uwe Merk as our new Director of Business Administration! In this key role, Uwe will take full responsibility for several critical functions, including Finance, Human Resources, Legal, Procurement, and IT. He will also oversee the strategic development of our business administration operations, driving international growth and ensuring compliance with legal and regulatory requirements. With a strong background in financial management, organizational development, HR leadership, and risk management, Uwe Merk will be instrumental in guiding our organization’s continued success and operational excellence. 🤝 We look forward to his leadership and the positive impact he will bring to our team! Are you a seasoned professional looking for new challenges and want to make a significant impact within the Life Sciences industry? Then check out our latest job offerings and be part of our journey towards excellence! https://lnkd.in/dMUMc_ZE #Leadership #BusinessAdministration #Finance #HR #IT #Procurement #NewHire

✴ We are thrilled to announce that three of our esteemed colleagues Christine Hirt, Sarra Othmani, MBA, and Nenad Čajko will be representing MAIN5 at the Ennov Europe User Meeting 2024 in Paris! 🗓 This event, taking place from September 30 to October 1, is a fantastic opportunity to engage with industry leaders, attend advanced training sessions, and explore the latest innovations in Ennov products. We are looking forward to networking with other professionals in the field, sharing insights and best practices. 🤝 If you’re attending, don’t miss the chance to connect with Sarra, Christine, and Nenad to discuss the latest industry trends, and discover how MAIN5 can support your organization's journey to excellence. 📧 Reach out to us to via sarra.othmani@main5.de to schedule a meeting. Looking forward to connecting with you! 👋 See you in Paris! #MAIN5 #EnnovUserMeeting2024 #Networking #Innovation #LifeSciences #Regulatory

We are delighted to share the highlights of our participation in the 28th GQMA Annual Conference. This esteemed event brought together leading professionals and experts in quality management to discuss and share the latest advancements and best practices in the field. MAIN5 was honored to contribute to the conference with two impactful presentations: 🔸 Managing Partner Alexander T. delivered an insightful presentation on PV Intelligence together with Dr. Tsambika Fuchs from Merck, sharing best practices and offering valuable insights from an end-to-end process to ensure local compliance with regulatory regulations on a global level. 🔸 Principal Consultant Jens Marburg presented on the validation of computerized systems in the field of artificial intelligence and a focus on differentiation of AI, clear communication and awareness that AI is not as new in the LifeScience industry as most people might think. His expertise and new perspectives were highly appreciated, adding significant value to the conference. We are proud of the positive feedback and the meaningful connections we made during the event. Our participation underscored MAIN5’s commitment to driving excellence and innovation in quality management. #GQMA #QualityManagement #Innovation #MAIN5 #Leadership #Excellence #CSV

👋 Come visit us at TOPRA Symposium 2024!   🗓 From September 30th to October 2nd MAIN5 will be exhibiting at the #TOPRA #Symposium 2024 in Rotterdam. Join us and meet our #Regulatory Experts: Katharina Mayer and Melita Luša.   Katharina is a seasoned regulatory affairs expert with 15 years in the life sciences industry. She excels in managing regulatory processes across labeling, CMC, and safety, ensuring efficiency and compliance. Her strengths in business process and project management, along with IT system implementation, drive successful project execution. Melita is a seasoned professional with over 10 years of experience in the pharmaceutical industry, specializing in GMP, regulatory affairs submissions, and quality assurance procedures and processes. She has extensive expertise in providing life sciences regulatory consulting services to global clients, focusing on regulatory information management, submissions, product management systems (xEVMPD, IDMP), and document management systems. Stop by to connect with us, discuss the latest industry trends, and discover how MAIN5 can support your organization navigating the complexities of regulatory affairs.   Visit us at #booth26 or send us a message at marjeta.zalec@main5.de, and we will arrange a meeting.   👋 Let’s meet at TOPRA Symposium 2024!  

👋We are thrilled to announce the newest additions to our MAIN5 team – meet Sarra Othmani, MBA and Piotr Wierzchowski. Sarra, joining us from France as Senior Director, Strategic Accounts, is bringing extensive experience gained over the years in the pharmaceutical industry, with a focus on key areas such as Regulatory Affairs and Pharmacovigilance. With a proven track record in driving innovative solutions, Sarra excels at building strong, lasting relationships with clients, particularly in the Life Sciences industry. Her expertise and focus on understanding customer needs will undoubtedly contribute to our success. Piotr will be expanding our team in Poland as Sales Manager. With years of expertise supporting clients in Life Sciences and leading international teams, Piotr brings deep knowledge in managing business development, agile processes, and implementing cutting-edge technologies. His analytical prowess and focus on ensuring quality through validation and qualification will be invaluable to our growth. 🤝Welcome aboard, Sarra and Piotr! Your diverse expertise and dynamic approaches will strengthen not just our team, but also our shared mission and values! Are you a seasoned professional looking for new challenges and want to make a significant impact within the Life Sciences industry? Then check out our latest job offerings and be part of our journey towards excellence! https://lnkd.in/dMUMc_ZE #Welcome #NewHires #Consulting #LifeSciences #CareerOpportunities #MAIN5 #JobOpprotunity #CompanyGrowth 

✴ Join us for an exclusive Partner Webinar with EXTEDO: "From Confusion to Control - Master Data Management in EXTEDOpulse" 🗓 Thursday, September 26th 2024 ⏰ 04:00 PM CEST I 10:00 AM EDT 🌐 https://lnkd.in/dczrG646 💡Discover how effective Master Data Management (#MDM) can streamline regulatory processes, enhance compliance, and reduce inefficiencies. Gain valuable insights from our expert consultants Joanna Borkowicz and Nenad Čajko on the fundamentals of MDM and the risks and challenges of operating without it and let Nicole Sagner from EXTEDO show you how a well-structured MDM approach can transform your regulatory business processes in #EXTEDOpulse powered by CARA. With 10 years of experience in life sciences, both at the health authority as well as the industry side, Joanna ads special value to the MAIN5 team. She specializes in Master Data Management (#SPOR), Regulatory Data Migrations, and the implementations of IDMP-related Data Quality Programs. Nenad Čajko excels as a Project Manager and IT/Business Consultant. With a robust 12-year track record in the life sciences sector, his profound knowledge in Regulatory Affairs, R&D and Quality Management is not just theoretical; it's built on practical, hands-on experience that translates into tangible benefits for our clients' business processes. 💻 Register now and learn how you can turn confusion into control within your regulatory department. #MAIN5 #EXTEDO #EXTEDOpulse #MasterDataManagement #RIM #LifeSciences #Regulatory

✴ Tomorrow, MAIN5 will be participating in the 28th #GQMA annual conference with Managing Partner, Alexander T., Principal Consultant, Jens Marburg, and Management Consultant, Verena Jachmann.   We are proud to contribute to this significant event in the field of quality management and assurance with two insightful presentations. 🗓 Friday, 20th of September 🕤 08:30 - 09:10 Alexander T., will present together with Dr. Tsambika Fuchs from Merck on PV Intelligence. They will highlight best practices and share invaluable Pharmacovigilance insights from an end-to-end process to ensure local compliance with regulatory regulations on a global level. 🗓 Friday, 20th of September 🕥 10:30 - 11:10 Jens Marburg, an expert in Computerized Systems Validation (#CSV), business process, solution design, and implementation, will deliver an engaging presentation on the validation of computerized systems in artificial intelligence, featuring an unexpected twist. With his extensive experience in the Life Sciences Industry as a Project and Service Manager, Jens’s session promises to be both informative and thought-provoking. 🤝 We look forward to connecting with you and engaging in meaningful discussions. #QualityManagement #AI #LifeSciences #Pharmacovigilance #DriveDigitalTransformation