Advanced CMC Masterclass - EU edition

TBA

Key points for successful development and registration of your pharmaceutical products

Technical and regulatory requirements for developing a medicinal product are becoming stricter every day, the products themselves become more and more complex.

TBA, 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.

Overview

Overview of challenges for post-approval CMC changes

Understand

Understand what are the essential requirements for a drug substance

Learn

Learn how to justify the choice of Registered Starting Materials (RSM)

CTD dossier

Understand the pharmaceutical development section of the CTD dossier

Trusted by over 17,000 delegates across leading companies

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Overview

Technical and regulatory requirements for developing a medicinal product are becoming stricter every day, and the products themselves are becoming more and more complex. This course will present key points in CMC which are currently the focus of Health Authorities, and which are critical for the successful development, registration, and lifecycle of pharmaceutical products. The course covers general requirements for small molecules and biologics.

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Trainer

Sophie Nageotte

Regulatory CMC Expert

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 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 (R&D through GMP)
Project managers with CMC responsibilities
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

Team participation?

*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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