Almost Three Years of the EU GMP ANNEX 1 MasterClass - EU edition

16-17 November, 2026

Lessons Learned & the Potential Role of AI

Advanced Medical Device Regulation MasterClass

This masterclass was designed to explore key regulatory updates, implementation challenges, and emerging best practices in sterile manufacturing.

16-17 November, 2026
Time Zone: UTC/GMT+1 /CET

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Key learnings

MDR

Deep understanding of the European Medical Device Regulation & its implications for global market access.

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

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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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Trainer

Dr. Ute Reichert

FOUNDER & CEO, BIO-TECHNOLOGY & PHARMA CON SULTING (BTC), SWITZERLAND

Dr. rer. nat. Dipl. Ing Ute Reichert has more than 20 years of experience in the biopharmaceutical and pharmaceutical industry, the last years as Head of an aseptic fill and finish production in Sandoz.

During her work for other major companies such as Lonza, Novartis, BI, and Biogen, she collected broad experience in varying positions in project management, process development, quality, and production.

As Project Manager in contract manufacturing organizations, she was responsible for planning and project prosecution concerning timelines and budget and was one of the key persons to establish project management in a biotech company.

As Head of Quality, her technical knowledge was complemented by the legal framework. She was intimately involved in the setup of business processes, definition of interfaces, and streamlining of processes to increase efficiency and optimize working conditions.

In Quality and Production positions, one of her main responsibilities was the training of employees.

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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?

-Professionals in production
-Quality management (QM)
-Engineering
-Validation
-IT
-Regulatory affairs involved in Annex 1 implementation

Ticket options for you

Full event
pass

Looking for an in-house training?

*minimum of 10 participants

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Testimonial

Our success stories

"The quality of the presentations, the relevance of the topics, and the overall level of discussion were outstanding and highly valuable from a professional and practical perspective. The event provided meaningful insights and a very good platform for knowledge exchange"

Ana Narasanova

Manager Credit Risk
NLB Banka
North Macedonia

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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