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Quality Content (ICH M4Q) of the Common Technical Document (CTD) for New Biotechnological Entities MasterClass - EU edition

21-22 May, 2024

Scope of the ICH Guidelines Q6B for biotechnological products

Quality Content (ICH M4Q) of the Common Technical Document (CTD) for New Biotechnological Entities MasterClass - EU edition

The Master Class focuses on ICH M4Q, providing guidance on the format and content of a registration application for drug substances and their corresponding drug products.

21-22 May, 2024, Virtual
Time Zone: UTC/GMT+1 /CET

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Pharma Online Masterclass

Overview

 

The Master Class focuses on ICH M4Q, providing guidance on the format and content of a registration application for drug substances and their corresponding drug products, as defined in the scope of the ICH Guidelines Q6B for biotechnological products. The Master Class also includes links to other existing ICH guidelines and their contents.

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Trainer
Hervé Broly
Hervé Broly
Starting with an engineering degree in agriculture, followed by a PhD in plant physiology, I joined the Blood Transfusion Center (Lille, France) in 1982 where I implemented a unit for the development and manufacture of monoclonal antibodies against blood groups, blood proteins and viral antigens. In 1991, I took the position of Head of Process Development and Manufacturing at Sorebio (Martillac, France), a contract manufacturing organization specialized in the development and manufacture of monoclonal antibodies for clinical development. I took the lead of that company in 1998 after it was bought by Serono, a Swiss biotech company (Geneva, Switzerland) in 1994.In 2003, I moved to Serono in Geneva as Global Product Team Leader in charge of managing the development of a recombinant Ig-fusion protein for the treatment of autoimmune diseases, moving that product from Phase I to Phase III.

As of November 2006, I’ve been appointed Vice-President, Head of Biotech Process Sciences at Merck-Serono, based in Vevey, Switzerland, in charge of developing and validating the manufacturing processes for biotechnological products. In that context, whereas Serono was mainly using perfusion processes for recombinant hormones and cytokines, we moved the company to large-scale manufacture of monoclonal antibodies using proprietary chemicallydefined cell culture media and feeds. After our participation to the FDA’s pilot program on Quality by Design, the concepts described in ICH Q8(R2) and ICH Q11 were implemented in our approach to gain process understanding. It was concluded by issuing a modernized approach for process validation at Merck (Darmstadt, Germany). More recently, we have introduced advanced processes such as intensified fed-batch and continuous downstream processing.
Myléne Talabardon
Myléne Talabardon
With over 20 years of experience in the pharmaceutical industry, Mylène has a strong experience in process development, technology transfer and process validation. She obtained her PhD in biotechnology from The Ohio State University and her environmental engineering degree from the Swiss Federal Institute of Technology (EPFL). In 2001, she joined BiogenIdec in cell culture process department, focusing on antibody production from lab scale to manufacturing scale. In 2004, she has been appointed head of cell culture department at Merck Serono and started working in validation according to QbD for biotech products. After 2 years as CMC lead for a biosimilar product, she was nominated Process Validation Expert, and in this position, she developed the Global Process Validation strategy for the company according to European and FDA regulations for pharmaceuticals, and supported CMC teams in developing Process Validation plans for new biologics as well as for legacy products.

Who should attend imgRECOMMENDATION

Who should attend?


• Regulatory professionals (CMC) responsible for creating a dossier
• Heads of CMC functions (e.g., 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

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 it’s 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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12+

Years of experience

399

Events organized

3,710

Speakers

21,521

Attendees

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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