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.
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.
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.
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.
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.
This practical course provides an in-depth understanding of signal detection, signal validation & assessment as well as signal communication.
This interactive course will bring clarifications on quality & regulatory requirements for combination products in the UK & US.
Join our CMC Analytical Comparability training led by experts to understand principles of protein structure and comparative analytics.
This practical course provides an in-depth understanding regulatory landscape for national CTA
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.
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.
The course will allow flexibility to address the challenges faced by the delegates with a variety of backgrounds, company experiences and business needs.
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.
This unique course provides a practical & in-depth understanding of CMC & quality requirements and brings clarifications on global regulation, requirements, compliance & quality concerns.
This course will profile best practice in project management, that is being aspired to by leading organisations.
Join Advanced IVIVC Professional training to understand the selection of the most appropriate data to establish IVIVC.
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.
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.