Pharma

The focus of this two days pharma online masterclass will be on providing an update of ongoing activities regarding medicines’ risk and signal management.

This training provide attendees with the building blocks for the establishment & delivery of an e-PIL strategic initiative.

This MasterClass will provide best understanding on how process validation for biotechnological processes.

This 2 days online masterclass gives practical examples from method validation and method transfer & pitfalls.

The program is designed to be interactive and engaging, with plenty of opportunities for hands-on practice and workshops.

CRO Oversight online masterclass provides an overview of the key concepts and best practices for CRO management in a global clinical trial setting.

 The MasterClass will cover these aspects that are relevant for non-toxicologists involved in drug development

The use of PK during drug development will also be described.

Key points for successful development and registration of your pharmaceutical products

This course will explores various approaches to particle size and shape characterization requirements for APIs

This masterclass will introduce participants to QbD concept, process validation and regulatory requirements

This comprehensive and interactive online course builds upon the fundamentals of Good Clinical Practice (GCP)

Clinical trials are the cornerstone for advancing medical knowledge by evaluating the efficacy and safety of health-related interventions

This course is providing practical insights in the challenges of Technology Transfer and on how implementation of Quality by Design principles.

This masterclass will introduce participants to QbD concept, process validation and regulatory requirements

The vaccine vigilance gap in poor countries needs to be addressed.

Understand the Quality and Regulatory requirements in Europe

This masterclass will highlight the impact of the EU GMPs Annex 1:2022 on microbiological and engineering depts.

Key points for successful development and registration of products in US

Concepts and Practices in Aligning the Internal Audit Program

A series of practical exercises will take place throughout the programme

This Masterclass will train you in CRO oversight, and teach you how to design and implement the systems your company needs.

Critical biological information to enable understanding of the cell and gene therapy tools and therapies both existing today and coming in the near future.

This is a central topic that is important for both successful marketing authorisation and GMP compliance

The attendee will also gain practical experience by applying the tools and skills learned to challenging scenarios.

The MasterClass will provide an updated overview on GMP-, as well as CTD requirements related to small molecule APIs

This online masterclass will address regulatory requirements related to cell bank establishment and testing.

This online masterclass will address regulatory requirements related to cell bank establishment and testing.

This comprehensive and detailed online masterclass describes the PK/PD studies from an industrial perspective to achieve a successful regulatory submission.

This Master Class is to introduce participants to the cornerstones of patient access and its value in context of CGT.

This masterclass will provide a comprehensive overview on any of the topics relevant in this context

The training aims to generate a common understanding of how to best interlink two areas and create highly efficient processes.