Pharma Smart Manufacturing 2025
The pharmaceutical industry is on the brink of a transformation—are you ready to embrace Industry 5.0?
Extractables & Leachables Analysis
Since its inception the topic of extractables and leachables has grown continuously. It has expanded into different dose forms and heighted regulatory expectations.
Market Access for Digital Health Technology
This hands-on workshop is designed to provide practical, real-world experience in navigating the regulatory, reimbursement, and market access challenges for digital health apps.
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.
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 in Pharma & Biotech Videorecording
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 Videorecording
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.
Novel Approaches & Techniques for Solubility Enhancement of Poorly Water-Soluble Drugs
This course provides critical insights into the novel techniques and strategies for the formulation, processing and characterization of poorly water-soluble drugs.
Lipid Nanoparticles for Drug/mRNA Delivery Videorecording
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.
Effective Project Management for Clinical Trials Videorecording
This course will focus on honing the skills for excellent Clinical Project Management.
Signal Management in Pharmacovigilance Videorecording
This practical course provides an in-depth understanding of signal detection, signal validation & assessment as well as signal communication.
Artificial Intelligence & Cloud: Validation and Data Integrity in a BioPharma GxP Environment
This course is a compilation of topics representing recent challenges related to CSV of AI or cloud-based systems in a GxP regulated context, and how CSV relates to data integrity.
Cross-Contamination Risk Assessment in Pharma Manufacturing
The training will share approaches how systematic risk management of cross-contamination risks can be performed and implemented in the QA system.
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.
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
This course is designed for drug R&D professionals who wish to develop their skills and knowledge in decision analysis, and to use these techniques to drive value and innovation.
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.
Cell & Gene Therapy Products – CMC & Quality Requirements
With the increasing complexity of new cell & gene therapies, as well as a rapid growth of these products in the development, unique challenges have emerged especially in the area of manufacturing and control.