How to submit variations in Europe MasterClass

Online MasterClass | 16 September, 2021

Variations are an essential part of pharmaceutical products lifecycle and a critical milestone for the management of post-approval changes. Regulation worldwide is not yet harmonised and this course will help you understand the specific legal framework of variations in Europe. Through practical examples and exercices, you will learn to define the best submission strategy, evaluate the documents to prepare and understand the challenges of implementing changes.

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How to submit variations in Europe MasterClass
Online MasterClass | 16 September, 2021
Online MasterClass | 16 September, 2021
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KEY LEARNING OUTCOMES
Clear view of the European legislation on variations
Gain a deep understanding of the specific legal framework of variations in Europe
Overall understanding of the procedure of submitting a variation & dossier
Learn how to define the best strategy for submitting a variation and understand the content of a variation dossier
Work on the EU variation guideline through case studies
Sharpen your understanding of EU variation by participating in case studies
Identify the differences between change categories (Type IA, IB, II)
Understand the differences between change categories (Type IA, IB, II)
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THE EVENT WILL START IN
TRAINER
Sophie Nageotte
Sophie Nageotte
Regulatory CMC Expert Independant consultant
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EVENT INTRODUCTION

Variations are an essential part of pharmaceutical products lifecycle and a critical milestone for the management of post-approval changes. Regulation worldwide is not yet harmonised and this course will help you understand the specific legal framework of variations in Europe. Through practical examples and exercices, you will learn to define the best submission strategy, evaluate the documents to prepare and understand the challenges of implementing changes.

Who Should Attend?

• Regulatory Affairs Professionals

• Regulatory Affairs CMC authors or reviewers

• Project managers with CMC responsibilities

• Quality assurance specialists

• Chemistry, Manufacturing & Controls (CMC) regulatory

• Analytical and stability laboratory managers (R&D through GMP)

 

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

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Managing Director – European pharma company

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

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Excellent trainer, super skilled, funny and extremely dynamic

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M&A Professional

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

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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.

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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.

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Banking professional from Europe

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