Entry Level CMC MasterClass - EU edition

27-28 January, 2025

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

Chemistry, Manufacturing, and Control (CMC) is key in the development and routine production of a medicinal product, and this course helps you understand the basic requirements and how to reflect them in the CTD Module 3. The course covers the general requirements for small molecules and biologics.

27-28 January, 2025, Virtual

Time Zone: UTC/GMT+1 /CET

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Key learnings

Different Level Requirements

Understand the Different Levels of Requirements in CMC during Development and Post-Approval Phase.

Key Stakeholders

Learn about the key stakeholders and their legal scope (competent authorities, ICH, pharmacopoeias)

CMC Data

Learn the basic CMC data requirements on drug substance and drug product on key topics

CTD dossier

Have an overview of the CTD dossier and a detailed review of the CTD Module 3

ICH guideline Q12

Get an introduction to quality by design and ICH guideline Q12

Trusted by over 17,000 delegates across leading companies

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Overview

Are ICH guidelines compulsory? What is the difference between analytical validation and analytical transfer? Do we need to test a compendial excipient? Chemistry, Manufacturing and Control (CMC) is key in the development and routine production of a medicinal product, and this course helps you understand the basic requirements and how to reflect them in the CTD Module 3. The course covers the general requirements for small molecules and biologics.

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Trainer

Sophie Nageotte

Regulatory CMC Expert
Independant consultant

With over 22 years of experience in the pharmaceutical industry, Sophie has a strong experience in the CMC Regulatory field. She gained her Masters degree in analytical chemistry from Manchester University and her Chemical Engineer degree from Montpellier School of Chemistry. She went on to work in pharmaceutical development and post-marketing CMC regulatory compliance in companies such as Bayer, PregLem and Laboratoires Galderma. She gained a strong experience in the worldwide regulatory environment for the development, manufacture and control of the medicines.

Since 2015, she runs her own consultancy, delivering advice in pharmaceutical development strategies and providing support in writing INDs and IMPDs, CTD Module 3 and QOS, preparing variations and answering questions from health authorities. Her experience covers a wide range of products (small molecules and biologics) and pharmaceutical forms.

Sophie also delivers training courses on European regulations for pharmaceuticals, writing of the Module 3, how to achieve global regulatory compliance, managing transfers of manufacturing sites and preparing variations for the ASEAN region.

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Reasons to attend a masterclass

Practical knowledge

Venture into undiscovered territories and gain inspiration through collaboration

Interactivity

Boost your professional skills by directly engaging with domain experts

World-class trainers

Gain value and learn from the best instructors

Networking

Build a top-notch community and advance your career

Who should attend img RECOMMENDATION

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

Ticket options for you

Full event
pass

Looking for an in-house training?

*minimum of 10 participants

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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

About GLC

Global Leadership Conferences began as an ambitious dream by three founders ten years ago. Today its an international series of interactive events, exploring the hottest topics in critical fields. Each year, thousands of professionals join us to challenge the status quo and learn innovative ways to create new solutions in Finance, Pharmaceutical, HR, Health & Safety, and Energy.

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