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pharma

CMC Readiness Challenge in Case of Expedited Programs, Process Changes, Comparability Studies and Biosimilars Masterclass

01-05 March 2027

01-05 March 2027Virtual

The Master Class focuses on CMC readiness challenges in the context of expedited programs, process changes, comparability studies, and biosimilars, providing guidance on strategies to ensure regulatory compliance and product quality under accelerated timelines.
 

01-05 March 2027

Masterclass Overview

The Master Class focuses on CMC readiness challenges in the context of expedited programs, process changes, comparability studies, and biosimilars, providing guidance on strategies to ensure regulatory compliance and product quality under accelerated timelines. It emphasizes the importance of robust planning, risk management, and scientific justification when implementing process modifications or demonstrating comparability between products.



 

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Trusted by over 17,000 delegates across leading companies

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Meet the expert

Trainer

Hervé Broly, PhD

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.
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Mylène Talabardon, Phd

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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Who should attend imgWHO SHOULD ATTEND

-Regulatory professionals (CMC) responsible for creating a dossier

-Heads of CMC functions

-Cell Line Development

-Drug Substance Process Development

-Analytical Development

-Formulation and Drug Product Development

-CMC Project Leaders

-Quality Assurance professionals

-Any other professionals responsible for generating data to be shared with regulatory authorities

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

Looking for an in-house training?

*minimum of 10 participants
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14+

Years of experience

600+

Events organized

4,000+

Speakers

25,000+

Attendees

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