MDR
Deep understanding of the European Medical Device Regulation & its implications for global market access.
pharma
Advanced Medical Device Regulation MasterClass - US edition
19-20 January, 2027
19-20 January, 2027Virtual
This course offers an in-depth and comprehensive exploration of the European Medical Device Regulation, designed to equip you with advanced knowledge and strategic insights.
19-20 January, 2027, Online
Time Zone: Eastern Standard Time (EST) / UTC04:00
Key learnings
Risk Classification
Mastery of complex risk classification systems and associated conformity assessment procedures.
Clinical Trials
Ability to design, conduct, and evaluate clinical trials in compliance with MDR guidelines.
Regulatory Challenges
Strategic knowledge of advanced regulatory challenges and effective solutions.
Case-Study
Enhanced collaborative skills through global peer exchange and case study analysis
FDA Requirements
Improved ability to align MDR compliance with international regulatory standards, such as FDA requirements
Trusted by over 17,000 delegates across leading companies
Overview
This course offers an in-depth and comprehensive exploration of the European Medical Device Regulation, designed to equip you with advanced knowledge and strategic insights. We will delve into complex risk classification systems, rigorous requirements for conformity assessment procedures, and the intricacies of clinical evaluations and trials, addressing both foundational and emerging regulatory challenges. The course is highly interactive, featuring expert-led break-out groups where you will analyze sophisticated case studies on borderline classification products and develop strategic approaches for market surveillance. You will enhance your expertise through collaborative workshops, exchanging insights with professionals from across the globe.
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Meet the expert
Trainer
Dr. Felix Kern
Head of Compliance at Merck KGaA
Dr. Felix Tobias Kern is the Associate Director Head of Compliance Launch and TechnologyCenter at the Merck KGaA in Darmstadt (Germany). He studied pharmacy in Mainz (Germany)and graduated at the Ludwig-Maximilians-University in Munich (Germany). He is an expert pharmacist for pharmaceutical analytics and pharmaceutical technology.
In the past 6 years he worked as a QA Manager in a worldwide operating medical device and medicinal product company, as well as head of manufacturing for the production of bulk tablets. Same time he gave lectures and practiced as consultant in the fields of GMP, quality,risk management, as well as regulatory requirements in the fields of medicinal products and medical devices. On top, Felix was involved in mRNA projects in Europe concerning design, manufacturing and quality topics of mRNA processes.
In the past 6 years he worked as a QA Manager in a worldwide operating medical device and medicinal product company, as well as head of manufacturing for the production of bulk tablets. Same time he gave lectures and practiced as consultant in the fields of GMP, quality,risk management, as well as regulatory requirements in the fields of medicinal products and medical devices. On top, Felix was involved in mRNA projects in Europe concerning design, manufacturing and quality topics of mRNA processes.
Reasons to attend a masterclass
Practical knowledge
Venture into undiscovered territories and gain inspiration through collaboration
Interactivity
Boost your professional skills by directly engaging with domain experts
World-class trainers
Gain value and learn from the best instructors
Networking
Build a top-notch community and advance your career
Who should attend?
-Regulatory Affairs Professionals seeking advanced knowledge in MDR compliance
-Quality Assurance Managers responsible for overseeing medical device conformity
-Clinical Affairs Specialists involved in designing and conducting clinical trials
-Medical Device Developers and Engineers focused on regulatory requirements
-Compliance Officers aiming to strengthen market surveillance strategies
-Product Managers and Strategic Planners looking to navigate global market entry
-Legal and Regulatory Consultants advising on medical device regulations
Ticket options for you
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*minimum of 10 participants
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