The EU Clinical Trial Regulation MasterClass

Online MasterClass | 21 & 22 October, 2021

The new EU Clinical Trial Regulation (536/2014) will replace the European Clinical Trials Directive (2001/20/EC) in 2022. Key aims of the new Regulation are to harmonise procedures for carrying out clinical trials across the EU and to simplify the clinical trial approval dossier by submission through a new clinical trial database and portal. Guidelines for enacting the new Regulation have also been prepared in a number of areas including inspection, investigational medicinal products and trial documentation. This course will provide an essential understanding to help with compliance with the new Regulation and associated implementing acts and other texts for carrying out clinical trials in the EU. The programme will highlight the most important of these key requirements and changes and how these are likely to impact on trials for biopharmaceutical companies, vendors and study sites.

THE EVENT WILL START IN
EVENT INTRODUCTION

The new EU Clinical Trial Regulation (536/2014) will replace the European Clinical Trials Directive (2001/20/EC) in 2022. Key aims of the new Regulation are to harmonise procedures for carrying out clinical trials across the EU and to simplify the clinical trial approval dossier by submission through a new clinical trial database and portal. Guidelines for enacting the new Regulation have also been prepared in a number of areas including inspection, investigational medicinal products and trial documentation. This course will provide an essential understanding to help with compliance with the new Regulation and associated implementing acts and other texts for carrying out clinical trials in the EU. The programme will highlight the most important of these key requirements and changes and how these are likely to impact on trials for biopharmaceutical companies, vendors and study sites.

Who Should Attend?

This course is ideal for anyone requiring an update on the EU Clinical Trial Regulation (536/2014). The course is relevant for those working in:

• Regulatory

• Clinical research

• Clinical operations

• Project management

• Pharmacovigilance

• Quality assurance (GCP auditors)

• Vendor/CRO professionals

• Study sites

And other professionals in pharmaceutical and biotechnology organisations conducting trials with drugs, biologics or combination products. It will also be of interest to those departments who liaise with/support clinical trial personnel, and all other professionals who want to know more about this important new regulation.

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Past Clients

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The level of professionalism of the trainer. Fine-tuned program without wasting time

Managing Director – European pharma company

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Clear and interesting way of presenting issues, good examples and very knowledgeable trainer.

HR Director - Multinational company based in Europe

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Excellent trainer, super skilled, funny and extremely dynamic

M&A Professional

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This training was interesting and I would love to attend more trainings like this.

HR Professional

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All lectures of the trainer was exactly what I was looking for and it was directly related to my experties and area that I am working. On top of that he prepared all lectures in a very practical way and also took his time to asnwers to the questions and he made sure that we got the asnwer. The organization of this class was also very good.

Pharmaceutical professional

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Comprehensive overview with very knowledgeable and experienced trainers. The break-out sessions were great as they made the course more interactive and allowed us to apply the concepts in practice.

Banking professional from Europe

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