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Viral Clearance MasterClass

Viral Clearance MasterClass

03 - 04 October, 2022

Viral Clearance online masterclass will give an overview of the sources and impacts of viral contaminations of biotherapeutics.

Advanced CMC MasterClass - US Edition

Advanced CMC MasterClass - US Edition

05 - 06 October, 2022

 This 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.

Implementation of ISO 13485 MasterClass

Implementation of ISO 13485 MasterClass

10 - 11 October, 2022

This MasterClass shall describe the general increase in combination products and in particular products now regulated by both drug and medical device regulation.

Pharma Packaging MasterClass

Pharma Packaging MasterClass

11 - 12 October, 2022

The Online training Course's goal to cover the technical and organisational requirements and procedures of pharma and healthcare packaging and technical operations in a 360-degree coverage.

Advanced Stability Testing of Pharmaceuticals MasterClass

Advanced Stability Testing of Pharmaceuticals MasterClass

10 - 13 October, 2022

This public training course will cover the scientific principles of chemical and physico-chemical degradation of active substances and pharmaceutical products.

Quality control for ATMPs and Biologics MasterClass

Quality control for ATMPs and Biologics MasterClass

17 October, 2022

The focus of this online training is on the ICH guideline Q6B.

Cleaning Validation Principles MasterClass - EU Edition

Cleaning Validation Principles MasterClass - EU Edition

17 & 18 October, 2022

 This online training will present you cleaning and cleaning validation in the life cycle of a pharmaceutical product.

Pharmacovigilance Audit and Inspections EU MasterClass

Pharmacovigilance Audit and Inspections EU MasterClass

18 & 20 October, 2022

This training will explore the key aspects of the pharmacovigilance audits, from planning audit programmes, conducting audits to delivering audit findings through reports.

Process Validation for Biotechnological Products Asian MasterClass

Process Validation for Biotechnological Products Asian MasterClass

18 - 21 October, 2022

This Online MasterClass will provide best understanding on how process validation for biotechnological products, which is the collection and evaluation of data from the process design stage through commercial production.

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

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

20 October, 2022

This 1 day online masterclass gives practical examples from method validation and method transfer. The new draft ICH guideline for method validation ICHQ2(R2) has been published for comment.

Leading a Strategic Account Management Approach in Pharma MasterClass

Leading a Strategic Account Management Approach in Pharma MasterClass

25 - 26 October, 2022

This Online Training will provide how to develop and lead your organisational SAM/KAM strategy and through best practice tools and techniques.

Cell Bank Establishment & Testing MasterClass

Cell Bank Establishment & Testing MasterClass

26 & 27 October, 2022

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

Ensuring Data Protection Compliance for Worldwide Clinical Trials - EU edition MasterClass

Ensuring Data Protection Compliance for Worldwide Clinical Trials - EU edition MasterClass

02 & 03 November, 2022

This Masterclass aims to provide the key rules to ensure data protection compliance for clinical trials while offering practical guidance and best practices face to real-live examples encountered in the conduct of EU-wide clinical trials.

ICH E8(R1) - US edition Masterclass

ICH E8(R1) - US edition Masterclass

03 & 04 November, 2022

ICH E8(R1) Masterclass is the umbrella guideline that maps to all the ICH “E” family, including ICH E6(R3), Good Clinical Practice

Cell Bank Establishment MasterClass (US)

Cell Bank Establishment MasterClass (US)

07 & 08 November, 2022

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

CRO Contracting and Oversight - EU Edition MasterClass

CRO Contracting and Oversight - EU Edition MasterClass

07 & 08 November, 2022

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

Auditing Major Projects in the Pharma sector - EU edition MasterClass

Auditing Major Projects in the Pharma sector - EU edition MasterClass

07 & 08 November, 2022

The Online MasterClass Provide you knowledge to promote the benefits of an audit involvement in all key projects and apply the concepts and practical application of a risk based approach to project audit.

QRM - ICH Q9: from theory to practice - EU edition Masterclass

QRM - ICH Q9: from theory to practice - EU edition Masterclass

07 & 08 November, 2022

This Master Class will not only introduce ICH Q9 and its practical meaning, but will focus heavily on Quality Risk Management implementation in an up-to-date Quality System including many real-life examples. 

Risk Management plans and its Implementation - EU edition MasterClass

Risk Management plans and its Implementation - EU edition MasterClass

07 - 09 November, 2022

The aim of a Risk Management plans and its Implementation Masterclass is to document the risk management system considered necessary to identify, characterise and minimise a medicinal product’s important risks. 

The EU Clinical Trial Regulation - Compliance - EU edition MasterClass

The EU Clinical Trial Regulation - Compliance - EU edition MasterClass

07 - 10 November, 2022

This MasterClass provides especially information for employees in pharmaceutical/biotech industry supervising the performing of Clinical Trials by CROs. Also employees “from outside Europe” get insights as how to run and supervise Clinical Trials in “Europe”.

Essentials of Internal Audit in the Pharma sector - EU edition MasterClass

Essentials of Internal Audit in the Pharma sector - EU edition MasterClass

09 - 10 November, 2022

The Online MasterClass Provide you knowledge to promote the benefits of an audit involvement in all key projects and apply the concepts and practical application of a risk based approach to project audit.

Cell Bank Establishment MasterClass

Cell Bank Establishment MasterClass

28 & 29 November, 2022

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

Pharma/Biotech Mergers and Acquisition MasterClass US

Pharma/Biotech Mergers and Acquisition MasterClass US

15 - 18 November, 2022

This specialized online training event will address the particular issues which affect Pharmaceutical Mergers and Acquisition work.

Basic Principles of Computerized Systems Compliance Using GAMP® 5 Version 2 - EU edition MasterClass

Basic Principles of Computerized Systems Compliance Using GAMP® 5 Version 2 - EU edition MasterClass

21 & 22 November, 2022

In this training, we will look at Basic Principles of Computerized Systems Compliance using ISPE’s GAMP5 Version 2 industry guidelines, compared to FDA’s Title 21 CRF Part 11 regulations, and EU’s Eudralex Volume 4 Annex 11 guidelines.

Entry Level CMC - US edition MasterClass

Entry Level CMC - US edition MasterClass

21 & 22 November, 2022

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

GAMP® 5 - US edition MasterClass

GAMP® 5 - US edition MasterClass

21 & 22 November, 2022

In this Master Class, we will review the current trends, including in technology and in FDA compliance and enforcement.

Cross-contamination Risk Assessment in Pharmaceutical Manufacturing - EU edition MasterClass

Cross-contamination Risk Assessment in Pharmaceutical Manufacturing - EU edition MasterClass

21-22 November, 2022

This training summarizes the current regulatory requirements to perform a structured assessment of cross-contamination risks.

Interactive Life Cycle Management - EU edition MasterClass

Interactive Life Cycle Management - EU edition MasterClass

21-22 November, 2022

This training is to wake the hidden part of your knowledge around the strong capabilities for successful implementation of you LCM projects.

Pharmaceutical Reference Standards - EU edition MasterClass

Pharmaceutical Reference Standards - EU edition MasterClass

22-23 November, 2022

In this training course you will learn about the correct use of official (pharmacopoeial) standards and regulatory requirements.

Process Validation for Biotechnological Products - EU edition MasterClass

Process Validation for Biotechnological Products - EU edition MasterClass

22 & 23 November, 2022

This MasterClass will provide best understanding on how process validation for biotechnological processes, which is the collection and evaluation of data from the process design stage through commercial production.

Medical Research: Dealing with Data Subjects’ rights under GDPR - EU edition MasterClass

Medical Research: Dealing with Data Subjects’ rights under GDPR - EU edition MasterClass

23 & 24 November, 2022

This Masterclass aims to provide the rules around the rights of the data subjects and the way to prepare to the sector of clinical trials and scientific research.

Contamination Control Strategy - EU edition MasterClass

Contamination Control Strategy - EU edition MasterClass

24 & 25 November, 2022

 This online training will present you what is meant by “Contamination Control Strategy”?

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

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

05 December, 2022

This 1 day online masterclass gives practical examples from method validation and method transfer.

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

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

07 - 08 December, 2022

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

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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