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Advanced Stability Testing in Pharmaceuticals MasterClass - US edition

Advanced Stability Testing in Pharmaceuticals MasterClass - US edition

02-05 October, 2023

A series of practical exercises will take place throughout the programme

CRO Oversight - EU edition MasterClass

CRO Oversight - EU edition MasterClass

16-17 October, 2023

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

Cell & Gene Therapy MasterClass - with focus on viral vectors - EU edition

Cell & Gene Therapy MasterClass - with focus on viral vectors - EU edition

16-18 October, 2023

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

Stability testing for APIs and Finished Products MasterClass – Overview EU requirements

Stability testing for APIs and Finished Products MasterClass – Overview EU requirements

17-18 October, 2023

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

CAPA and Root Cause Analysis - EU edition MasterClass

CAPA and Root Cause Analysis - EU edition MasterClass

17-18 October, 2023

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

Chemically Synthetized APIs - CTD and GMP Aspects - EU edition MasterClass

Chemically Synthetized APIs - CTD and GMP Aspects - EU edition MasterClass

18-19 October, 2023

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

Cell Bank Establishment & Testing - EU edition MasterClass

Cell Bank Establishment & Testing - EU edition MasterClass

18-19 October, 2023

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

Cell Bank Establishment & Testing - US edition MasterClass

Cell Bank Establishment & Testing - US edition MasterClass

24-25 October, 2023

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

Advanced Pharma Technology Transfer - EU edition MasterClass

Advanced Pharma Technology Transfer - EU edition MasterClass

24-26 October, 2023

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

PK/PD in Drug Discovery and Development - EU edition MasterClass

PK/PD in Drug Discovery and Development - EU edition MasterClass

October 24-27, 2023

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

Auditing Procurement and Contract Management MasterClass - EU edition

Auditing Procurement and Contract Management MasterClass - EU edition

25-26 October, 2023

The success of a business strategy is significantly impacted by the quality of both the procurement strategy and how the resulting contracts are managed.

Psychometric Tools in Recruitment - EU edition MasterClass

Psychometric Tools in Recruitment - EU edition MasterClass

25-26 October, 2023

The workshop aims to provide an understanding of psychometric tools and how to use them effectively in the recruitment process.

Requirements for pharmaceutical QC laboratories MasterClass - EU edition

Requirements for pharmaceutical QC laboratories MasterClass - EU edition

02-03 November, 2023

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

Nature-Related Risks MasterClass - US edition

Nature-Related Risks MasterClass - US edition

07-08 November, 2023

Explore how businesses are at risk of environmental change

Development of generics MasterClass - EU edition

Development of generics MasterClass - EU edition

07-08 November, 2023

Paving the Way from Development to Lifecycle Management

Entry Level CMC MasterClass - EU edition

Entry Level CMC MasterClass - EU edition

13-14 November, 2023

The Entry Level CMC Masterclass covers the general requirements for small molecules and biologics.

The Fundamentals of Risk Management in Clinical Trials MasterClass - EU edition

The Fundamentals of Risk Management in Clinical Trials MasterClass - EU edition

14-15 November, 2023

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

Pharma Market Access MasterClass - US edition

Pharma Market Access MasterClass - US edition

14-15 November, 2023

Unlock the keys to successful market access in the pharmaceutical industry

Fundamentals of Pharmacokinetics MasterClass - EU edition

Fundamentals of Pharmacokinetics MasterClass - EU edition

14-17 November, 2023

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

Clinical Trial Regulations MasterClass - US edition

Clinical Trial Regulations MasterClass - US edition

15-16 November, 2023

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

Leachables and Extractables MasterClass - US edition

Leachables and Extractables MasterClass - US edition

16-17 November, 2023

Learn more about identification and control of Leachables and Extractables

Entry Level CMC MasterClass - US edition

Entry Level CMC MasterClass - US edition

20-21 November, 2023

The Entry Level CMC Masterclass covers the general requirements for small molecules and biologics.

Fundamentals of Toxicology MasterClass - EU edition

Fundamentals of Toxicology MasterClass - EU edition

27-30 November, 2023

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

Signal Management in Pharmacovigilance MasterClass - US edition

Signal Management in Pharmacovigilance MasterClass - US edition

27-28 November, 2023

The focus of this two half day training will be on providing an update of ongoing activities regarding medicines’ signal management.

Method Validation and Transfer with focus on the new ICH Q2(R2) MasterClass - US edition

Method Validation and Transfer with focus on the new ICH Q2(R2) MasterClass - US edition

22-23 January 2024

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

Fundamentals of Toxicology MasterClass - US edition

Fundamentals of Toxicology MasterClass - US edition

23-26 January, 2024

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

Impurities MasterClass - EU edition

Impurities MasterClass - EU edition

29-30 January, 2024

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

Pharma Contract Drafting MasterClass - US edition

Pharma Contract Drafting MasterClass - US edition

05-08 February, 2024

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

ESG Stress Testing MasterClass - EU edition

ESG Stress Testing MasterClass - EU edition

05-08 February, 2024

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

Carbon Accounting MasterClass - EU edition

Carbon Accounting MasterClass - EU edition

06-07 February, 2024

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

Fundamentals of Pharmacokinetics MasterClass - US edition

Fundamentals of Pharmacokinetics MasterClass - US edition

06-09 February, 2024

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

Medical Device Regulation MasterClass - EU edition

Medical Device Regulation MasterClass - EU edition

08-09 February, 2024

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

Adaptive Design in Clinical Trials MasterClass - US edition

Adaptive Design in Clinical Trials MasterClass - US edition

15-16 February, 2024

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

HSE360 Summit 2023

HSE360 Summit 2023

09-10-11 October, 2023

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

Non-interventional Studies In-House Training

Non-interventional Studies In-House Training


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

QP’s role in clinical project setup In-House Training

QP’s role in clinical project setup In-House Training


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.

Method Validation and Transfer with focus on the new ICH Q2(R2) In-House Training

Method Validation and Transfer with focus on the new ICH Q2(R2) In-House Training


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

Cell Bank Establishment & Testing In-House Training

Cell Bank Establishment & Testing In-House Training


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

Process Validation for Biotechnological Products In-House Training

Process Validation for Biotechnological Products In-House Training


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

Advanced CMC In-House Training

Advanced CMC In-House Training


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. 

Advanced Forecasting In-House Training

Advanced Forecasting In-House Training


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

Blockchain for Business In-House Training

Blockchain for Business In-House Training


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 In-House Training

Blockchain for Pharma In-House Training


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

Fixed Income Portfolio Management In-House Training

Fixed Income Portfolio Management In-House Training


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.

Meeting the In Vitro Medical Devices Regulation In-House Training

Meeting the In Vitro Medical Devices Regulation In-House Training


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

Smart Packaging and Technical Operations in Pharma In-House Training

Smart Packaging and Technical Operations in Pharma In-House Training


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

Agile Audit and Assurance In-House Training

Agile Audit and Assurance In-House Training


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.

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Testimonial

Our success stories

"High attention to detail in course content and very well delivered"

Simon Halsey
Product Development Manager
Essentra Packaging
United Kingdom

Our success stories

"Very good training led by two knowledgeable and open experts. Excellent insight given on many complex topics. Interactive and highly useful"

Aurelie Vivicorsi
USP PD Team Manager
Celonic AG
Switzerland

Our success stories

"Great course, impressed with the knowledge of the trainers and ability to answer wide variety of questions!"

Emilia Szwej
Manager, Senior Investigator
MT Sword Laboratories (BMS)
Germany