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.
Toxicology, ADME & Early Drug Development Plan
Building an Integrated Safety Testing Strategy based on ADME and Toxicology. The purpose of this Toxicology, ADME & Early Drug Development Plan is to understand the concept of a combined ADME-Toxicology approach.
Pharma & Biotech R&D Portfolio Management in the 21st Century
This course is designed for those who already have some experience in R&D project & portfolio management, decision analysis and prioritization, and wish to develop their skills and knowledge in the evolving portfolio management tools, techniques and strategies to maximize value and drive innovation.
MES & Automation in Pharma Manufacturing
Manufacturing Execution Systems (MES), fully integrated to enterprise, quality, and shop floor equipment and automation systems, have become mainstream practice in regulated life sciences manufacturing environments as the industry embraces Pharma 4.0 ideologies.
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.
Signal Management in Pharmacovigilance
This practical course provides an in-depth understanding of signal detection, signal validation & assessment as well as signal communication.
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.
CMC Analytical Comparability: Methods & Strategies for Biologics
Join our CMC Analytical Comparability training led by experts to understand principles of protein structure and comparative analytics.
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.
Digital Quality in Clinical Trials
This unique course provides a practical & in-depth understanding of electronic systems and technologies used in clinical trials, and brings clarifications on global regulation, requirements, compliance & quality concerns.
Practical Decision Analysis for Drug Research & Development
The course will allow flexibility to address the challenges faced by the delegates with a variety of backgrounds, company experiences and business needs.
Pharmacovigilance Inspections & Audits Updates
This course will provide a comprehensive, yet practical guide to pharmacovigilance audits and inspections best practice to help navigate what is required to demonstrate compliance.
Cell & Gene Therapy Products – CMC & Quality Requirements
This unique course provides a practical & in-depth understanding of CMC & quality requirements and brings clarifications on global regulation, requirements, compliance & quality concerns.
Effective R&D Project Management in Pharma & Biotech
This course will profile best practice in project management, that is being aspired to by leading organisations.
Advanced IVIVC Professional
Join Advanced IVIVC Professional training to understand the selection of the most appropriate data to establish IVIVC.
Quality & Regulatory Requirements for Drug Device Combination Products in the EU
This course will cover the definition of combination products, EU regulatory pathways, and will explain the current state of developments as medical device manufacturers and marketing authorisation holders prepare for the new requirements.
Monoclonal Antibodies
This unique 2-day course is designed for advanced persons & specialists in the field of protein therapeutics or participants who have emphasis to jump into this new exciting business field.
