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The course will cover serialisation and aggregation of medicinal products

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

Unlock the keys to successful market access in the pharmaceutical industry

Clinical trial conduct in the United States must follow the FDA’s regulations as published in the CFR

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

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

Current developments for impurities in small molecule APIs and respective medicinal products

This online course builds upon the fundamentals of risk management in clinical trials

This intensive online training will be held over 4 consecutive half-day sessions for lawyers, and paralegals,working in the for the pharmaceutical industry.

In this course attendees will gain a comprehensive overview of popular stress testing quantitative techniques.

The masterclass explores carbon accounting best practices across scope 1, 2, 3.

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

This course give you an overall and complete overview about the requirements of the European Medical Device Regulation.

This course give you an overall and complete overview about the requirements of the European Medical Device Regulation.

Latest trends about continuous monitoring and guidance on best practices from US framework SOX

 Understand the values of PK/PD studies in drug R&D from an industrial perspective

Bridging Technical Analysis with Management

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

Understand the challenges of the use of data analytics in audit and fraud

This intensive online training will be held over 4 consecutive half-day sessions for lawyers, and paralegals,working in the for the pharmaceutical industry.

Adoption of New Critical to Quality Requirements

The training will provide practical advice on benefit risk framework and assessment

Key elements for a successful development of a drug product analytical development

The course will cover serialisation and aggregation of medicinal products

Over the past two decades, Omics have revolutionized the field of oncology

A holistic approach and practical examples on the connection between signal/risk management with benefit risk and PBRERs

Microbiological contaminations can occur on many levels.

A comprehensive overview of the BCBS framework on IRRBB and implementation

Beyond Child's Play

A phenomena for complex therapeutics – Biologics, Biopharmaceuticals, Biosimilars & ATMPs

Implementation of Quality by Design principles.

This online masterclass gives practical examples from method validation and method transfer.

The training will provide practical advice on benefit risk framework and assessment

Learn more about identification and control of Leachables and Extractables

Discussions about different types of IP and the value of IP

This is a very interactive online course with a lot of workshops, putting the theoretical concepts into practice.

HSE360 will provide participants with a platform for information exchange and networking with experts from all across the world.

NIS is helpful to obtain information forming hypotheses for new research projects.

QP`s role in clinical project setup will highlight the key points for quality and the qualified person (QP) to consider when setting up clinical trial.

This in-house training will give practical examples from method validation and method transfer & pitfalls. Also Participants can ask questions interactively.

This in-house training will address potential issues encountered when establishing cell banks and will discuss operational aspects for ensuring good quality cell banks. 

This In-house training provides deeper understanding on how process validation for biotechnological processes.

This in-house training will present Technical and regulatory requirements for developing a medicinal product which are becoming stricter every day, the products themselves become more and more complex. 

This In-house training will provide participants with an overview of approaches to forecasting ranging from the classical linearforecasting methods to non-linear approaches.

This In-house training covers the theory & practice of Blockchains/Distributed Ledger Technology. It provides far more than just an understanding of the technology. 

Blockchain for Pharma is an ideal candidate to address issued across supply chain, clinical trials and R&D.

This In-house training considers some of the tactics that could be used to hedge the associated market and credit risk of a fixed income portfolio.

The aim of this In-house training is to provide all those involved with IVDs a broad overview of the IVDR with practical guidance.

This In-house training will support you in collecting, sorting and proper understanding of the requirements of the serialisation Requirements.

This in-house training will provide an introduction to the Agile methodology and Outline the areas of focus for the audit and assurance review of Agile project.