Advanced CMC MasterClass

Online MasterClass | 20-21 October, 2021

Technical and regulatory requirements for developing a medicinal product are becoming stricter every day, the products themselves become more and more complex. This course will go through the key scientific points for the development and registration of your medicine, and provide a focus on US FDA and Europe expectations for CMC. The course covers general requirements for small molecules and biologics.

Methodology

The participants will gain knowledge via lecture-type sessions, letting substantial time for Q&A and discussions. Furthermore the training places great emphasis on practical examples through case studies.

THE EVENT WILL START IN
EVENT INTRODUCTION

Technical and regulatory requirements for developing a medicinal product are becoming stricter every day, the products themselves become more and more complex. This course will go through the key scientific points for the development and registration of your medicine, and provide a focus on US FDA and Europe expectations for CMC.

The course covers general requirements for small molecules and biologics.

Who should attend?

• Quality assurance specialists

• Regulatory Affairs CMC authors or reviewers

• Analytical and stability laboratory

• Project managers with CMC

• Chemistry, Manufacturing & Controls (CMC) regulatory

• Product scientists and test method technical experts (R&D and QC)

• Process analytical chemists and process development scientists

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Past Clients

Testimonials

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

Managing Director – European pharma company

Testimonials

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

HR Director - Multinational company based in Europe

Testimonials

Excellent trainer, super skilled, funny and extremely dynamic

M&A Professional

Testimonials

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

HR Professional

Testimonials

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

Testimonials

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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GHAZAL ZOHREHNEJAD

Managing Director / Co-founder

LÁSZLÓ ÁRVAI

Managing Director / Co-founder

KRISZTIÁN ÖTVÖS

Managing Director / Co-founder