MDR
Deep understanding of the European Medical Device Regulation & its implications for global market access.
pharma
Almost Three Years of the EU GMP ANNEX 1 MasterClass - EU edition
16-17 November, 2026
16-17 November, 2026Global / Virtual
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
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.
#masterclass #glceurope #pharma #globaltraining #MedicalDevice #MedicalDeviceRegulation
Meet the expert
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.
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.
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 eventpass
Learn moreLooking for an in-house training?
*minimum of 10 participants
Learn more 14+
Years of experience
600+
Events organized
4,000+
Speakers
25,000+
Attendees
Take the next step