Pharma

Entry Level CMC - EU edition MasterClass

Entry Level CMC - EU edition MasterClass

12-13 December, 2022

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

ICH Q10: How to manage your Quality System including Quality KPIs - EU edition MasterClass

ICH Q10: How to manage your Quality System including Quality KPIs - EU edition MasterClass

12-13 December, 2022

This MasterClass is completed by fundamentals of an appropriate Quality Culture which constitute the basis for a successful PQS - besides all regulations.

Risk Management plans and its Implementation - EU edition MasterClass

Risk Management plans and its Implementation - EU edition MasterClass

12-14 December, 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. 

Cell Bank Establishment & Testing - US edition MasterClass

Cell Bank Establishment & Testing - US edition MasterClass

23-24 January, 2023

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

Cell Bank Establishment & Testing - EU edition MasterClass

Cell Bank Establishment & Testing - EU edition MasterClass

30 & 31 January, 2023

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

QP’s role in clinical project setup - EU edition MasterClass

QP’s role in clinical project setup - EU edition MasterClass

06-07 February, 2023

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) - US edition MasterClass

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

07-08 February, 2023

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

Process Validation for Biotechnological Products - EU edition MasterClass

Process Validation for Biotechnological Products - EU edition MasterClass

07-08 February, 2023

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.

Good Clinical Practices - US edition MasterClass

Good Clinical Practices - US edition MasterClass

07-08 February, 2023

This online practical course provides an in-depth understanding of GCP requirements and their practical implications.

Pharma Good Distribution Practice - EU edition MasterClass

Pharma Good Distribution Practice - EU edition MasterClass

09-10 February, 2023

This informative training with two RP’s / RPI’s for all things GDP.

Impurities - EU edition MasterClass

Impurities - EU edition MasterClass

13-14 February, 2023

This topic is covered by the ICH M7 guideline which a harmonised practical framework.

Clinical Project Management - US edition MasterClass

Clinical Project Management - US edition MasterClass

13-16 February, 2023

This is a very interactive online course with a lot of workshops, putting the theoretical concepts into practice.

Process Validation for Biotechnological Products - US edition MasterClass

Process Validation for Biotechnological Products - US edition MasterClass

13-16 February, 2023

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

Good API GMP manufacturing practices with focus on ICH Q7 - EU edition MasterClass

Good API GMP manufacturing practices with focus on ICH Q7 - EU edition MasterClass

13-15 February, 2023

Interactive course providing excellent knowledge of the requirements laid down in ICH Q7

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

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

15-16 February, 2023

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

Post-Authorisation Safety Studies - EU edition MasterClass

Post-Authorisation Safety Studies - EU edition MasterClass

20-22 February, 2023

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

Advanced CMC - US edition MasterClass

Advanced CMC - US edition MasterClass

27-28 February, 2023

This online masterclass will go through the key scientific points for the development and registration of your medicine.

Pharmacovigilance on the Internet and Social Media - US edition MasterClass

Pharmacovigilance on the Internet and Social Media - US edition MasterClass

27 February – 01 March, 2023

Interaction between pharmaceutical companies and patients/users through the InternetSocial media and two-way communication.

Non-interventional Studies - US edition MasterClass

Non-interventional Studies - US edition MasterClass

01-02 March, 2023

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

Clinical (IMP) QP oversight - EU edition MasterClass

Clinical (IMP) QP oversight - EU edition MasterClass

06-07 March, 2023

The `Clinical(IMP) QP oversight` course will highlight the critical control points for the Qualified Person when handling Investigational Medicinal Product projects.

Dissolution testing - EU edition MasterClass

Dissolution testing - EU edition MasterClass

08-09 March, 2023

A number of aspects in the paper are also relevant for sustained and extended release dosage forms.

Advanced CMC - EU edition MasterClass

Advanced CMC - EU edition MasterClass

08-10 March, 2023

 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.

CMC Readiness Challenge in case of Expedited Programs for Biotechnological Products - US edition Masterclass

CMC Readiness Challenge in case of Expedited Programs for Biotechnological Products - US edition Masterclass

13-14 March, 2023

This Online Masterclass will delineate potential adaptations to the traditional approach to productdevelopment, product characterization, manufacturing and timepoint for full completion of certain quality data packages.

Viral Clearance - US edition MasterClass

Viral Clearance - US edition MasterClass

16-17 March , 2023

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

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

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

20 March, 2023

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

Advanced Stability Testing in Pharmaceuticals - EU edition MasterClass

Advanced Stability Testing in Pharmaceuticals - EU edition MasterClass

22-23 March, 2023

A series of practical exercises will take place throughout the programme to give participants the opportunity to apply their knowledge under the guidance of our experienced trainers.

Pharmacovigilance on the Internet and Social Media - EU edition MasterClass

Pharmacovigilance on the Internet and Social Media - EU edition MasterClass

27-29 March, 2023

Interaction between pharmaceutical companies and patients/users through the InternetSocial media and two-way communication.

Good API GMP manufacturing practices with focus on ICH Q7 - US edition MasterClass

Good API GMP manufacturing practices with focus on ICH Q7 - US edition MasterClass

20-22 March, 2023

Interactive course providing excellent knowledge of the requirements laid down in ICH Q7

Process Validation for Biotechnological Products - Australian edition MasterClass

Process Validation for Biotechnological Products - Australian edition MasterClass

20-23 March, 2023

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.

Pediatric Drug Development - EU edition MasterClass

Pediatric Drug Development - EU edition MasterClass

27-29 March, 2023

Participants in this online masterclass will learn which trials in minors make sense, and which ones are pointless and even harmful.

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

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

28-31 March, 2023

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

10+

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299

Events organized

3,410

Speakers

17,761

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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