We offer training to transfer our knowledge and skills, improve work quality, enhance communication and collaboration, build capacity, and support long-term success. It demonstrates our commitment to ongoing learning and development, fosters a culture of improvement, and promotes positive change and growth. Our training reflects our values of excellence, integrity, and collaboration and our belief in the power of knowledge to transform lives.

Training Pragrams at Molgenium

The ATMP Analytical Procedure Life Cycle

Masterclass

This course will cover the Analytical Procedure Life Cycle for Advanced Therapy Medicinal Products (ATMPs), from development to validation, implementation, and maintenance, including regulatory requirements, method selection, optimization, validation, and lifecycle management. Ideal for professionals in ATMP development, manufacturing, quality control, and regulatory affairs.

 

Scheduling
14 & 15 June 2023 | 08:30 - 16:30 CET | Online / In-house Training

CMC for Cell Therapy Products

Masterclass

This course will provide an in-depth understanding of Chemistry, Manufacturing, and Controls (CMC) requirements for Cell Therapy Products (CTPs), covering regulatory landscape, cell sourcing and characterization, product design, manufacturing processes, and quality control. Ideal for professionals involved in CTP development, manufacturing, quality control, and regulatory affairs.

 

Scheduling
14 & 15 July 2023 | 08:30 - 16:30 CET | Online / In-house Training

CMC for Gene Therapy Products

This course will provide a comprehensive overview of Chemistry, Manufacturing, and Controls (CMC) requirements for Gene Therapy Products (GTPs), covering regulatory landscape, vector design and characterization, manufacturing processes, quality control, and stability. Ideal for professionals involved in GTP development, manufacturing, quality control, and regulatory affairs.

 

Scheduling
14 & 15 August 2023 | 08:30 - 16:30 CET | Online / In-house Training

Stability Testing for Drugs and Biologics

This course will cover the fundamentals of stability testing for drugs and biologics, including regulatory requirements, stability study design, analytical methods, and data analysis. Ideal for professionals involved in drug and biologics development, manufacturing, quality control, and regulatory affairs.

 

Scheduling
14 & 15 May 2023 | 08:30 - 16:30 CET | Online / In-house Training

Analytical Method Validation and Transfer

This course covers the regulatory requirements, method validation parameters, and best practices for analytical method validation and transfer for pharmaceutical products. Ideal for professionals involved in drug development, manufacturing, quality control, and regulatory affairs.

 

Scheduling
05 & 06 May 2023 | 08:30 - 16:30 CET | Online / In-house Training

EU GMP for ATMP: Implementation and Compliance

This course provides a comprehensive understanding of the European Union (EU) Good Manufacturing Practice (GMP) requirements for Advanced Therapy Medicinal Products (ATMPs), covering implementation strategies, quality management systems, and compliance. Ideal for professionals involved in ATMP development, manufacturing, quality control, and regulatory affairs.

 

Scheduling
14 & 15 July 2023 | 08:30 - 16:30 CET | Online / In-house Training

Global Clinical Research Training

Workshop

This workshop provides practical training in the fundamentals of global clinical research, including clinical trial design, conduct, and reporting, as well as regulatory requirements and ethical considerations. Through interactive exercises and case studies, participants will gain valuable skills for successful clinical research. Ideal for professionals involved in clinical research, including investigators, study coordinators, monitors, and regulatory affairs personnel.

 

Scheduling
14 & 15 July 2023 | 08:30 - 16:30 CET | Online / In-house Training

Introduction to Manufacturing and Regulatory Processes

Workshop

This workshop provides an overview of manufacturing and regulatory processes for pharmaceutical and biopharmaceutical products, including drug development, process validation, quality control, and regulatory submissions. Through case studies and interactive exercises, participants will gain a solid understanding of the key principles of manufacturing and regulation. Ideal for professionals involved in drug development, manufacturing, quality control, and regulatory affairs.

 

Scheduling
14 & 15 July 2023 | 08:30 - 16:30 CET | Online / In-house Training