Advanced Medical Device Regulation MasterClass

11-14 March, 2025

Global Medical Device regulations

This course give you an overall and complete overview about the requirements of the Global Medical Device regulations.

13-14 March, 2025

Budapest, Hungary

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Key learnings

MDR

Overview of requirements from the MDR

FDA requirements

Comparison to FDA requirements

Conformity

Conformity Assessment Procedure

Clinical Evaluation

Clinical Evaluation and Trials - yes but how?

Workshop

Workshop with three classification examples

Borderline Products

Discussions about borderline products

Trusted by over 17,000 delegates across leading companies

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Overview

This course give you an overall and complete overview about the requirements of the Global Medical Device Regulation. We will discuss the basics about risk classification systems, about the requirements for conformity assessment procedures, about clinical evaluations and trials and about regulatory challenges. The course is very interactive: In Break-Out Groups we will review many examples covering borderline classification products and reports for the market surveillance. Overall you will broaden your experiences in a workshop by exchange with colleagues all over the world.

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Trainer

Dr. Felix Kern

Head of Compliance
Merck KGaA

Dr. Felix Tobias Kern is head of compliance at the Merck KGaA in Darmstadt (Germany). He studied pharmacy in Mainz (Germany) and graduated at the Ludwig-Maximilians-University in Munich. He is 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.

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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 img RECOMMENDATION

Who should attend?

QA Professionals
Regulatory Affairs Manager
Officials from Authorities
Manufacturing Experts
Pharmacovigilance Experts
For beginners and advanced

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Testimonial

Our success stories

"High attention to detail in course content and very well delivered"

Simon Halsey

Product Development Manager
Essentra Packaging
United Kingdom

Our success stories

"Very good training led by two knowledgeable and open experts. Excellent insight given on many complex topics. Interactive and highly useful"

Aurelie Vivicorsi

USP PD Team Manager
Celonic AG
Switzerland

Our success stories

"Great course, impressed with the knowledge of the trainers and ability to answer wide variety of questions!"

Emilia Szwej

Manager, Senior Investigator
MT Sword Laboratories (BMS)
Germany

About GLC

Global Leadership Conferences began as an ambitious dream by three founders ten years ago. Today its an international series of interactive events, exploring the hottest topics in critical fields. Each year, thousands of professionals join us to challenge the status quo and learn innovative ways to create new solutions in Finance, Pharmaceutical, HR, Health & Safety, and Energy.

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