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Signal and Risk Management in Pharmacovigilance - EU edition MasterClass

Signal and Risk Management in Pharmacovigilance - EU edition MasterClass

06-07 June, 2023

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

Advanced E-Pil and E-Leaflet - EU edition MasterClass

Advanced E-Pil and E-Leaflet - EU edition MasterClass

08-09 June, 2023

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

Process Validation for Biotechnological Products - EU edition MasterClass

Process Validation for Biotechnological Products - EU edition MasterClass

14-15 June, 2023

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

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

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

22-23 June, 2023

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

Cracking the Code of Biocompatibility - US edition MasterClass

Cracking the Code of Biocompatibility - US edition MasterClass

24-25 July, 2023

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

CRO Oversight - US edition MasterClass

CRO Oversight - US edition MasterClass

26-27 July, 2023

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

Fundamentals of Toxicology - US edition MasterClass

Fundamentals of Toxicology - US edition MasterClass

21-24 August, 2023

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

Fundamentals of Pharmacokinetics - US edition MasterClass

Fundamentals of Pharmacokinetics - US edition MasterClass

28-31 August, 2023

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

Environmental, Social Governance - EU edition MasterClass

Environmental, Social Governance - EU edition MasterClass

31 August-1 September, 2023

A growing number of organisations are recognizing that adopting ESG best practices can be an important business differentiator

Advanced CMC - EU edition MasterClass

Advanced CMC - EU edition MasterClass

05-06-07 September, 2023

Key points for successful development and registration of your pharmaceutical products

Particle Size Characterization - US edition MasterClass

Particle Size Characterization - US edition MasterClass

05-08 September, 2023

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

Entry Level Process Validation for Biotechnological Products - EU edition MasterClass

Entry Level Process Validation for Biotechnological Products - EU edition MasterClass

05-08 September, 2023

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

GCP for Clinical Research Professionals - EU edition MasterClass

GCP for Clinical Research Professionals - EU edition MasterClass

11-12 September, 2023

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

Adaptive Design in Clinical Trials - EU edition MasterClass

Adaptive Design in Clinical Trials - EU edition MasterClass

11-12 September, 2023

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

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.

Entry Level Process Validation for Biotechnological Products - US edition MasterClass

Entry Level Process Validation for Biotechnological Products - US edition MasterClass

11-14 September, 2023

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

Advanced Vaccine Vigilance - US edition MasterClass

Advanced Vaccine Vigilance - US edition MasterClass

18-19 September, 2023

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

ESG Stress Testing - EU edition MasterClass

ESG Stress Testing - EU edition MasterClass

18-21 September, 2023

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

Impact of EU Annex 1:2022 on Microbiological and Engineering depts. - EU edition MasterClass

Impact of EU Annex 1:2022 on Microbiological and Engineering depts. - EU edition MasterClass

21-22 September, 2023

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

Advanced CMC - US edition MasterClass

Advanced CMC - US edition MasterClass

25-26 September, 2023

Key points for successful development and registration of products in US

Internal Auditing to MDSAP - EU edition MasterClass

Internal Auditing to MDSAP - EU edition MasterClass

25-26 September, 2023

Concepts and Practices in Aligning the Internal Audit Program

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.

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.

Patient Advocacy and Access in Gene Therapy MasterClass - US edition

Patient Advocacy and Access in Gene Therapy MasterClass - US edition

25-26 October, 2023

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

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

Development of generics: From R&D to GMP MasterClass - EU edition

Development of generics: From R&D to GMP MasterClass - EU edition

07-08 November, 2023

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

HSE360 Summit 2023

HSE360 Summit 2023

09-10 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