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

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

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

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

Drafting the well structured, practical, clear and concise documents which achieve their objectives

The Master Cell Bank is not only the starting point of GMPs but also the starting point of the therapeutical recombinant proteins and GTP

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

A comprehensive overview of the BCBS framework on IRRBB and implementation

 Structured products are now used by professional investors, advisors and asset managers worldwide

Pharmacopoeias play a major role in quality standards for the manufacture and control of medicines in Europe and worldwide

A theoretical and practical understanding of stress testing methodology

What the FDA is and how the entity is organized

Learn how to define, evaluate, and respond to risks, and also how to define critical data.

Learn how to define, evaluate, and respond to risks, and also how to define critical data.

PSD2 is also being developed further (PSD3/PSR) and is conquering the world

Including EU's latest on PSD3, PSR, FIDA

Development in a workplace with no or minimum L&D budget

Numerous case studies to apply the knowledge to specific use cases

Working knowledge of blockchain and understanding of strategic implications

Interventional studies fall into the scope of Directive 2001/20/EC and will no be the object of this Masterclass.

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

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

Numerous case studies will guide you through interactive discussions on practical application of KYC/ CDD requirements

Learn more about identification and control of Leachables and Extractables

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

Principles, advantages and potential challenges of the adaptive design methodology

Today, process validation comprises three main steps:

Statistical impact on drug supply as well as how to properly set-up your IRT system

Statistical impact on drug supply as well as how to properly set-up your IRT system

Key points for successful development and registration of your pharmaceutical products

Quality requirements of pharma and healthcare packaging

Operational Risk poses significant challenges for all firms

Navigating Uncertainty in Business Strategy

Navigating Uncertainty in Business Strategy

Microbiological contaminations can occur on many levels.

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

Mastering Drug-Device Combination Products

Components of successful project management such as interaction between project activities and key decisions will be highlighted

An advanced-level masterclass for participants with a minimum of 5-10 years of industry experience

Impurities in active ingredients, excipients, medicinal products and packaging materials

Climate change poses significant challenges to businesses and financial institutions

Climate change poses significant challenges to businesses and financial institutions

Master Cell Bank is not only the starting point of GMPs but also the starting point of the manufacturing process of therapeutical recombinant

Strategies for nurturing and developing talent within an organization

Strategies for nurturing and developing talent within an organization

Methodologies essential for data integration and interpretation in reservoir engineering

What is meant by “Contamination Control Strategy”? A complex system of measures designed to minimize the risk!

 What is meant by “Contamination Control Strategy”?

Mastering Dissolution Testing: From Basics to Advanced Techniques

Gain invaluable insights into the development, regulation, and deployment of AI-powered medical devices

The biggest HR Conference in the Europe

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

Pharmacokinetics (PK) play a key role in drug development

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

This in-house training will inform about quality testing procedures of packaging materials such as AQL testing in packaging controls and reduced sampling procedures.

What are the key components of communication?

What are the key components of communication?

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.