Stability & Shelf Life of Biologics
The purpose of this Stability & Shelf Life of Biologics Training Course is to get comprehensive overview on stability and shelf-life regulatory landscape.
Companion Diagnostics (CDx) – Navigating the Regulatory Challenges
The implementation of the EU In Vitro Diagnostic Device Regulation 2017/746 (IVDR) has introduced new processes for the authorization of performance studies and conformity assessment of companion diagnostic devices (CDx) in Europe.
Pharma & Biotech R&D Portfolio Management in the 21st Century
This two-day training course is designed for portfolio management professionals in Pharma and Biotech who want to enhance their skills and gain insights into the latest tools and techniques for managing complex portfolios.
Bioassays & Bioanalytical Methods
This practical Bioassays and Bioanalytical Methods online live training is focused on complex therapeutics, such as Biopharmaceuticals, Biologics and Biosimilars.
Signal Management in Pharmacovigilance
This practical course provides an in-depth understanding of signal detection, signal validation & assessment as well as signal communication.
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.
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.
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.
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.
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.
