Sponsored Webcast: Navigating Early Feasibility and First-in-Human Studies: A Comparative Analysis of EU and US Approaches (On demand)
This comprehensive webcast explores the multifaceted aspects of early feasibility and first-in-human Studies in the EU and US. Regulatory and clinical experts from NAMSA will guide you through the regulatory landscapes, clinical trial processes, and key differences between these two major markets. Whether you’re a seasoned professional or new to the field, this webcast will help you to have a better understanding of these complex regions and consider which one is the best option according to your needs.
Registration Fees & Deadlines
Learning Objectives
Understanding the US Approach: Gain a comprehensive understanding of the processes and requirements for Early Feasibility Studies in the US.
Mastering the EU Regulations: Learn about the EU’s loosely defined approach to First-in-Human Studies, and how to navigate within this regulatory landscape
US and EU - A Comparative Analysis: Discover the key differences and contrast between the US and EU in terms of regulatory requirements, clinical trial processes, and more. This knowledge will empower you to make informed decisions when planning and executing these types of studies in regulated regions.
Who Should Attend?
- Regulatory affairs Managers
- Clinical affairs Managers
- Clinical and Regulatory Strategists
- Product development scientists and engineers
Audience Learning Level
Basic: Content is introductory in nature and requires no requisite knowledge or experience to grasp concepts and related exercises. Basic educational activities are meant to establish a foundation of knowledge and/or competence that will be expanded upon in practice or in higher level activities.
Speakers
Pedro Eerdmans
NAMSA Clinical Director, Global Strategy Services, NAMSA
Pedro Eerdmans has more than 25 years of experience within the medical device industry, with a deep understanding in the medical device development from concept to market release and post market follow-up. Eerdmans has held several different positions within the medical device industry, including chief executive officer, chief medical officer, vice president of medical affairs, director, manager, and physician. He has experience in almost all levels of the medical device space, including hospitals, contract research organizations, manufacturers (4-30,000 employees) and notified bodies. While head of the notified body, he managed to obtain EU MDR accreditation, and as medical director he was responsible for the evaluation of the medical evidence to grant CE certification. He also managed global clinical teams while based in Europe and the US. Under his supervision, several medical devices received CE mark, and most recently 3 Investigational Device Exemption (IDE) approvals were granted.
Richard A. Vincins
Principal Strategy Consultant, NAMSA
Richard Vincins has been in the industry for 30+ years, focused on medical devices specifically in these therapeutic areas: catheter technology for numerous clinical applications, laser medical devices for surgical and aesthetic procedures, software applications for digital health and In-Vitro Diagnostic (IVD) medical devices.
His previous roles have been in quality engineering, quality assurance, compliance, regulatory affairs and clinical development support. Prior to joining NAMSA, Richard held positions with Emergo Consulting, bioMerieux, Lumenis, Medtronic and C.R. Bard. He’s spent the last 15 years in consulting, spanning multiple companies and medical device types. In his role as Vice President of Quality Assurance Consulting at Emergo, he compiled and submitted numerous 510(k) applications for US FDA, supported IDE and clinical applications, generated Technical Documentation for EU MDD/EU MDR, and provided technical writing services for clinical evaluations, biological evaluations and risk management files. His role in leading consultants and teams led to the clearance and approval of new, novel medical devices in the U.S., Europe, Canada and other markets around the world.
Carla M Wiese
Principal Strategy Consultant, NAMSA
Carla Wiese has over 25 years’ experience in the medical device industry in project management, research and development and regulatory disciplines. Her experience covers therapeutic areas including cardiovascular, renal, neurology and gynecology; and device types including clinical decision support software, cancer detection tools, and drug coated products among others. Prior to joining NAMSA in 2017, Carla held positions with Boston Scientific, Solace Therapeutics, and most recently the US Food and Drug Administration (FDA). At the FDA, Wiese served as lead reviewer for cardiovascular devices before becoming the program director of the early feasibility studies (EFS) program, where she oversaw development of new review strategies to help increase EFS in the United States.
Nimrita Verma
Clinical Study Manager, NAMSA
Nimrita has been in the industry for 20 years with 4 years focused on medical devices specifically in these cardiovascular, oncology, and software. She has been involved in different aspects that cover clinical trials, from project management, to conducting clinical trials, or preparing documents and submissions in accordance with all applicable regulations. Also, she has been involved in software projects facilitating clinical trials to be accessible on a digital platform. In addition to working with vascular grafts and specialized dental fillings for pediatrics.
