Training Program for CMC Leaders - EU edition

24th March - 05th December, 2025

Rich with practical insights and real-world applications

This comprehensive CMC Training Program is an invaluable resource for CMC leaders in biotechnology seeking support for their product/process development and validation activities, by acquiring the comprehensive knowledge of the latest regulatory standards and industry best practices.

24th March - 05th December, 2025, Virtual
Time Zone: UTC/GMT+1 /CET

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TRAINING FEATURES

Interactive discussions and Q&A sessions

1-on-1 with trainer

Case studies from the trainers experience

Certificate of completion

Course documentation

Trusted by over 17,000 delegates across leading companies

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LEARNING OUTCOMES

Rich with practical insights and real-world applications, this comprehensive CMC Training Program is an invaluable resource for CMC leaders in biotechnology seeking support for their product/process development and validation activities, by acquiring the comprehensive knowledge of the latest regulatory standards and industry best practices. Whether you are an experienced CMC project leader or junior to the eld, this program will empower you to achieve excellence in leading your projects to success.

Upon completion of the 7-month training program, attendees will:

- Integrate all the sciences and guidelines needed to navigate in the complex landscape of QbD and regulatory standards for product development to achieve successfull CMC dossier submissions.
- Become condent to establish and efficiently lead CMC programs at all stages, with ease (from phases I, II, III up to product launch).

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Each participant will receive 3 books from the trainer for free, as valuable sources of written guidance and reference

7 MODULES, 84 HOURS + 7 WORKSHOP

24th - 27th MARCH 2025	-QUALITY CONTENT (ICH M4Q) OF THE COMMON TECHNICAL DOCUMENT (CTD) FOR NEW BIOTECHNOLOGICAL ENTITIES
14th - 18th APRIL 2025	-PRODUCT DEVELOPMENT PLAN -MANUFACTURING PROCESS VALIDATION FOR BIOTECH PRODUCTS
19th - 22nd MAY 2025	-CELL LINE DEVELOPMENT -MANUFACTURING CELL BANK ESTABLISHMENT AND TESTING -DESIGN AND DEVELOPMENT OF CELL-BASED ASSAYS
23rd - 26th JUNE 2025	-CRITICAL QUALITY ATTRIBUTES OF BIOTHERAPEUTICS -DEVELOPMENT AND VALIDATION OF ANALYTICAL METHODS
29th - 03rd SEPTEMBER OCTOBER 2025	-PREVENTION AND DETECTION OF VIRAL AND BACTERIAL CONTAMINATION -VIRAL CLEARANCE STRATEGIES
27th - 30th OCTOBER 2025	-CMC READINESS CHALLENGE IN CASE OF EXPEDITED PROGRAMS -PROCESS CHANGES, COMPARABILITY STUDIES AND BIOSIMILARS
01st - 05th DECEMBER 2025	-CONTINUOUS MANUFACTURING PROCESSES, TECH TRANSFER AND SCALE-UP FOR MANUFACTURING

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Trainer

Hervé Broly, PhD

Hervé is an internationally recognized bioprocess expert with over 42 years of experience in the development, manufacture, and validation of biotech processes. He is credited with 21 patents and has authored 69 scientific papers. Over his 35-year career at Merck-Serono, he served as Vice-President of the Process Development Department. Hervé's expertise spans all CMC aspects of biotechnological products for IND/CTA and BLA/MAA applications, leading to the approval of several BLA/MAA submissions. He has extensive experience in creating high-quality, compliant CMC regulatory documents and developing strategies for complex CMC challenges. Hervé has also played a crucial role in health authority interactions and inspections at company sites.

Mylène Talabardon, Phd

Mylène brings 25 years of extensive experience in the biotechnology industry, having worked with renowned companies such as BiogenIdec, Sano , and Merck-Serono. She has demonstrated exceptional leadership in CMC, contributing directly to multiple clinical and commercial drug substance and drug product manufacturing facilities in both technical and management roles. Prior to transitioning to consultancy, Mylène led a multi-disciplinary CMC team to successfully achieve commercial approval for a biosimilar. Her expertise encompasses process development and validation, innovative technologies, process technology transfer and scale-up, manufacturing operations and investigations, CRO/CMO management, continuous improvement, regulatory requirements, and product launches.

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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

Ticket options for you

Full event
pass

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*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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