Pharma

Current regulatory requirements to perform a structured assessment of cross-contamination risks.

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.

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.

 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

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.

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.