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 Laboratory Digitalization & Validation
The need for digitalization in the pharmaceutical laboratories is continuously evolving & there is a need for a more unified approach to laboratory and data 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.
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 & 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.
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.
Monoclonal Antibodies Quality & Regulatory Requirements
This course will encourage the adoption and the utilisation of the full extent of the current regulatory guidance and share practical examples as to how to achieve.
Quality Requirements for Biotech Products
This practical course provides an in-depth understanding regulatory landscape for national CTA procedures.
Quality & Regulatory Requirements for Biosimilars in the EU
The training aims to create deeper understanding why biotechnological products – and as a consequence Biosimilars – are a unique product category and what aspects have to be considered in R&D and Drug Regulatory Affairs.
Advanced IVIVC Professional
Join Advanced IVIVC Professional training to understand the selection of the most appropriate data to establish IVIVC.
