Experienced expert in medicinal products, medical devices, supplements and plant protection products R&D at every stage - from planning and scientific advice through supervision to the closure and finalization of the project. This approach decreases life-cycle management costs for taxpayers because doses that are near expiration can be rotated into A founder of several start-ups in the e-health industry and a member of the board and supervisory board of several R&D companies. Session Details:
Sean has more than 20 years of experience in the industry, most of that time spent building up innovative global regulatory operations teams, achieving product approvals, and supporting global expansion at smaller companies.
Bayer: Our Path to Digitally Connected Clinical Trials
Former Editorial Director of Thomson Reuters Drug News, Alvaro started his career making significant contributions to the field of Immunology at Yale School of Medicine. She has a passion for driving innovation and collaborating with industry peers to deliver better clinical trial experiences for all stakeholders, especially sites and patients. Expertise ranging from Clinical Research experience in Pharma, Biotech and CRO with focus on Oncology, Immunology, Infectious Disease, Respiratory indications and Rare/Orphan diseases. Theyll discuss why they decided to implement the Vault Quality to RIM Connection, how they transformed legacy variation management processes, and their top lessons learned for other companies that are considering a similar project. Dermavant Sciences
Dr. Nicholas Lakin has over 20 years of experience as an R&D strategy consultant and currently leads clinical consulting services at Syneos Health. They focus on building user-friendly and integrated systems to optimize pharmaceutical drug development. Prior to Medidata, Paul was Director of Health Outcomes at CRF Health, an eCOA provider, where he led their health outcomes team. 2. Kevin is passionate about improving healthcare and utilizing technology that makes a real difference to patients lives. Floris' deep understanding and experience in medical device product development and clinical research helps him discuss these challenges and find solutions. He has focused on understanding potential safety signals within drugs which could have negative impacts on lung health. Senior Director, TMF Head. He joined Forge in November of 2020 and has been responsible for developing and implementing the Veeva Quality Management System to support clinical manufacturing for Forges clients. A copy of your NYS license, permit, or ID card is worth six points. Managing Director, Hitesh Shah
Most of his career was spent in manufacturing in engineering, quality, and new product development, and has spent the last 8 years focused on product management, developing cloud QMS solutions. Replace the attached chart with a new chart ? Well wrap up the regulatory zone with an interactive discussion around the Vault RIM user experience. CSL Behring
Clinical ink is the global life science company that brings data, technology, and patient science together. VP, Product Management, Vault Safety. As a director in PwCs Cloud & Digital Practice, he is part of the team pushing the next wave of innovation and integration in the AI/ML space, specifically for life sciences in quality and clinical. RESILIENCE. Thu 1:00 p.m. Pukar Bhandari
BTH Recruitment are a boutique headhunting firm specialising in the Pharmaceutical and Clinical industry. He has detailed knowledge of the overall clinical research process and the operational and system-based inter-dependencies between functional groups within clinical development. Boehringer Ingelheim shares its strategic vision for a One Medicine Platform to bring treatments to patients faster. Avoid profanity, slander or personal attacksdirected at an author or another user. He is an author of several scientific publications in this field. In addition to the role at EU level, she is currently
She is passionate about leveraging systems to decrease cycle times during study start-up. Alastair has 30+ years of experience in the biopharmaceutical development of pre- and post-approval drugs, joining Syneos Health on 2017. She is also involved in rolling out artificial intelligence tools to create more effective ways of working across the business. Solutions, Regulatory Joe is a passionate leader who fosters a what if? mindset to make a case for change. This enables us to provide you with qualified patients that streamline your recruitment process. Learn how to use the tools workflow offers and the benefits of OneWorkflow. AI & Disruptive Technology: Harnessing the future of Artificial Intelligence to transform clinical trials
Vertex Pharmaceuticals
In addition, she has held various leadership roles ranging from trial master file (TMF) strategy, oversight, and inspection readiness to providing management for global clinical operations study support teams. Veeva
The process technologies will be enhanced to
In his role as VP, eCOA Science & Consulting, Bryan brings extensive experience and expertise to achieve smarter drug development, clinical trial design and execution (including decentralized and remote trials) to vastly expand the reach and access of trials to more patients, provide improved patient experience and data quality to deliver accelerated drug & device development programs. Sr Director, Regulatory Operations, Kelsey Edwards
His expertise includes managing changes, innovation, and transformation (including process & technology) across clinical R&D and implementing eClinical technologies (EDC, ePRO, clinical data repository, knowledge management systems). VP Strategy, Veeva RTSM, Steve Simmerman
AMG 337 inhibits proliferation in MET-dependent cancer cell lines.
Jennifer is the director of enterprise-wide quality information systems at Gilead Sciences, where her team acts as the business owners of Vault QualityDocs, Vault QMS, and the GxP Learning Management System. Kurt is the business lead for site monitoring and study start-up at BMS. Session Details:
is Chief Medical Officer at LEO Innovation Lab, LEO Pharmas independent innovation unit, where he leads a decentralized clinical trials unit, Studies&Me, working to personalize treatment development. Alvaro Arjona is Editor-in-Chief at GlobalData Media, with extensive experience in leading editorial teams covering Pharma & Healthcare. Following this, Estrella held at post-doctoral position at ICI (now Astra Zeneca) in Macclesfield, UK. Our core business focuses on small-medium sized life sciences businesses, sourcing and securing the highest calibre individuals in the market (i.e. Executive Director, Global Quality Systems & Compliance, Tristram Liddiard
Session Details:
His favorite thing about Veeva is the speed of solution delivery: Our product roadmap is always ambitious. His team of R&D consultants operates globally from the UK, India, Argentina, and the US. Opportunities include thought leadership, exhibition space, private drinks and dinner networking events and much more. Accomplished and growth-focused professional with 17+ years experience managing
Moderna will share how they quickly scaled operations by incorporating label management functionality into their end-to-end regulatory solution. Veeva
In 2016 AOP Orphan received approval for one new product (RAPIBLOC).
She is Lillys Vault Clinical Operation system owner and has worked to scale-up CTMS in Vault Clinical Operation for the past three years.
She has authored of 3 books, 20 scientific articles, and 24 contributions to scientific congresses. Stefania has over 10 years of pharmaceutical, marketing, communications and digital experience in different company. Session Details:
Biography:
Alexions (AstraZeneca Rare Disease) Vice President, Global Head of Country Operations Management, Patryk is accountable for driving transformative improvement in the delivery of Alexion Sponsored clinical trial programs and leading the country operations team providing oversight of clinical studies conducted at sites across the Alexion portfolio worldwide. Sarepta Therapeutics: Best Practices for Release Management
Alexis has managed global studies from Phase I FIH to logistically complex Phase III studies and has a passion for operational excellence, process management and study finance. She worked in the medical device industry in the process development area, developed risk-based quality strategy in the clinical space, and led auditing teams conducting risk-based audits. Martine has been a champion of diversity, equality, inclusion and belonging, having been recognized by the Healthcare Businesswomans Association as a Luminary in 2020, and efforts by serving as an executive sponsor for Alexions flagship Women In Leadership (WIL) employee resource group. Wed 1:00 p.m. Greg Rosen
U.S. Buys $290M Worth of Drugs in Preparation for Nuclear PCI is a leading global CDMO, providing clients with integrated end-to-end drug development, manufacturing and packaging capabilities that increase their products speed to market and opportunities for commercial success.
Amgen will maintain this supply in vendor-managed inventory, ASPR said regarding the nations newly acquired $290 million supply of Nplate. View Profile View Forum Posts Private Message View Articles Member. Saamas unified, AI-driven clinical data analytics cloud platform seamlessly integrates, curates, and animates unlimited sources of structured, unstructured, and real-world data to deliver actionable insights across all therapeutic areas. Please contact us first if the concentration exceeds the DMSO solubility of the batch of drug. We are passionate about our work, creating value for patients and customers while generating opportunities for employees to thrive. View In Agenda, Operations Manager Clinical Operations,SGS. CEO of WPD Pharmaceuticals Inc and WPD Pharmaceuticals Sp. We integrate clinical operations excellence, laboratory expertise, and advanced data sciences to deliver on the promise of personalized therapy; translating research into real-world results and forever reimaging how to get there. Director, Product Management, Clinical Operations, Nima Shah
Resources Microelectronics Limited, which is the technology arm
Thu 1:00 p.m. Bryce Mesko
He is currently CEO. Senior Strategy Director, Study Training, Annie Linker
Steve has over 20 years of experience in the life sciences industry. Sverre is very interested in making clinical trials efficient, in both study design but also in the processes and technologies used. RTSM is built on Rave EDC, so there is no double data entry and minimal reconciliation expediting study start-up and study-close out.
Hear how Sanofi is leveraging it to enhance user experience and make real time decisions. CEO Dr Michael-Robin Witt holds a Ph.D. in Neuropharmacology from the Royal School of Pharmacy, Copenhagen, Denmark. Veeva
Hear about how Vertex is moving beyond phase one of their adoption of Vault CDMS to now running all of their new studies on Vault EDC. YPrime'scloud-based technology streamlines clinical trial data collection and management.
Wall St rises as midterm election begins; Amgen hits record high By Reuters - Nov 08, 2022 14 Binance agrees to deal to buy FTX's non-U.S. operations By Investing.com - Nov 08, 2022 6 A Database Failover comes into action when database failure is detected by the Exchange Information Service. Get the free daily newsletter read by industry experts. Many biopharmaceutical trial sponsors rely on or scientific leaders to help design and optimize their protocols and statistical analysis plans. Formed through the merger of IMS Health and Quintiles, IQVIA has more than 58,000 employees worldwide. www.medrio.com. Wed 3:00 p.m. Colleen McGraw
The process is not difficult, but it may be best left for more seasoned users. Session Details:
Nuvisan Pharma Service is a contract research organization with decades of experience in pharmacological and pharmacokinetic studies, delivering a comprehensive range of solutions for clinical trials. You must ensure that the solution obtained, in the previous addition, is a clear solution before proceeding to add the next solvent. With over 19 years of industry experience spanning technical support, project management, sales and strategy roles, Natalie has designed and delivered RTSM solutions for an extensive range of studies and customers. He has 13 years of life sciences and IT industry experience in system administration, support, maintenance, and upgrades in the different areas of pharmacovigilance and clinical trials. 1:00 p.m. Greg Rosen < a href= '' https: //radaronline.com/p/united-states-buys-290-million-worth-drugs-preparation-nuclear-emergencies/ '' U.S! P.M. 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