pharma
Training Program for CMC Leaders - EU edition
14th September 2026 - 09th April 2027
14th September 2026 - 09th April 2027Vienna, Austria
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.
14th September 2026 - 09th April 2027, Virtual
Time Zone: UTC/GMT+1 /CET
KEY BENEFITS
1-on-1 with the Trainers
Case studies for each topic
Workshop after every sessions
Access to 3 Books by the Trainers
Trusted by over 17,000 delegates across leading companies
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-module 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, 80+ HOURS + 7 WORKSHOPS
| 14 -18 SEPTEMBER 2026 | ICH M4Q CTD Quality Module for New Biotech Products |
| 05 - 09 OCTOBER 2026 | PDP & MPV for Biotech Products |
| 02 - 06 NOVEMBER 2026 | CLD, MCB Establishment & Testing, Cell-Based Assay Development |
| 07 - 11 DECEMBER 2026 | CQAs of Biotherapeutics & Analytical Method Dev. & Validation |
| 25 - 29 JANUARY 2027 | Viral & Bacterial Contamination Control and Viral Clearance |
| 01 - 05 MARCH 2027 | CMC Readiness for Expedited Programs, Process Changes & Comparability |
| 05 - 09 APRIL 2027 | Continuous Manufacturing,Tech Transfer & Scale-Up |
Meet the expert
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.
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 eventpass
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