Clinical Trials Quality & Inspection Updates
This practical course provides an in-depth understanding of current and planned GCP requirements and their practical implications as well as insights into the current GCP inspection focus and hot topics.
Quality & Regulatory Requirements for Inhalation Drug Products
This course will cover the aspects of the human respiratory tract that are relevant to the delivery of medicines to the lungs.
Advanced Protein Aggregation & Characterization
This practical Advanced Protein Aggregation & Characterization course provides an insight into the diversity of aggregates and particulates present in biopharmaceuticals revealed by new orthogonal methods.
Stability & Shelf Life of Cell & Gene Therapy Products
This 2-day practical workshop is focused on ATMPs & brings a comprehensive overview on stability and shelf-life regulatory landscape, as well as analytical methods for stability assessment of your cell & gene therapy products.
Computerized Systems Validation, Data Integrity & Cloud Computing in Pharma & Biotech
This course is a compilation of topics representing recent challenges related to CSV of cloud-based systems in GxP regulated context, and how CSV relates to data integrity assurance.
Quality & Regulatory Requirements for Drug Device Combination Products in the UK & US
This interactive course will bring clarifications on quality & regulatory requirements for combination products in the UK & US.
Quality Requirements for Biotech Products
This practical course provides an in-depth understanding regulatory landscape for national CTA procedures.
Lipid Nanoparticles for Drug/mRNA Delivery
After the successful development of lipid nanoparticles (LNPs) comprising messenger RNA (mRNA) for vaccination against Covid-19, the interest in mRNA and nanoparticle systems for various therapeutic applications has surged tremendously.
Pharma & Biotech CSV in the Cloud (IaaS/PaaS/SaaS)
This course is meant to be an advanced CSV course focusing on selected topics where validating cloud-based systems differ from on-premise solutions.
Quality & Regulatory Requirements for Biosimilars in the EU
The training aims to create deeper understanding why biotechnological products – and as a consequence Biosimilars – are a unique product category and what aspects have to be considered in R&D and Drug Regulatory Affairs.
Advanced IVIVC Professional
Join Advanced IVIVC Professional training to understand the selection of the most appropriate data to establish IVIVC.
Annex 1
Attention is given by the regulators and inspectors in this field, which generally is considered as a technology of pharmaceutical manufacturing with immanent high risk.
Computerized Systems Validation & Data Integrity in Pharma & Biotech
This course is a compilation of topics representing recent challenges related to CSV, and how CSV relates to data integrity assurance.
New ICH & EMA Quality Guidelines
In summary, this course will help the delegates to identify important new GMP and Regulatory aspects which should be considered throughout the entire life cycle of their specific products and avoid waste of time and money, thereby.
