Prevention and Detection of Viral and Bacterial Contamination, Viral Clearance Strategies Masterclass

25-29 January 2027

Viral Clearance Strategies

Prevention and Detection of Viral and Bacterial Contamination, Viral Clearance Strategies

25-29 January 2027

Masterclass Overview

The Master Class focuses on prevention and detection of viral and bacterial contamination, as well as viral clearance strategies, providing guidance on the scientific and regulatory approaches necessary to ensure product safety and integrity in biotechnological manufacturing. It emphasizes the importance of contamination control measures, robust testing methodologies, and validated clearance processes to meet international regulatory expectations.

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Trusted by over 17,000 delegates across leading companies

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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Who should attend img WHO 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

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*minimum of 10 participants

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Testimonial

Our success stories

"The quality of the presentations, the relevance of the topics, and the overall level of discussion were outstanding and highly valuable from a professional and practical perspective. The event provided meaningful insights and a very good platform for knowledge exchange"

Ana Narasanova

Manager Credit Risk
NLB Banka
North Macedonia

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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