Freeze Drying for Biologics/Pharmaceutics
This practical course will focus on the freeze-drying process from formulation and thermal analysis to cycle development and optimization, packaging and troubleshooting.
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.
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 development, unique challenges have emerged especially in manufacturing and control.
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.
BA/BE, Dissolution & Biowaivers
This course will evaluate every aspect of BA/BE from the regulations and types of protocol studies to bioanalysis, statistical analysis and reporting.
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.
Immunogenicity of Biologics, Biopharmaceuticals & ATMPs
This unique course provides a practical & in-depth understanding of immunogenicity risk assessment and risk minimization.
Signal Management in Pharmacovigilance
This practical course provides an in-depth understanding of signal detection, signal validation & assessment as well as signal communication.
Effective Project Management for Clinical Trials
This course will focus on honing the skills for excellent Clinical Project Management.
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.
