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Immunogenicity MasterClass - EU edition

13-14 March, 2024

A phenomena for complex therapeutics – Biologics, Biopharmaceuticals, Biosimilars & ATMPs

Immunogenicity MasterClass - EU edition

An important topic for complex therapeutics like Biologics, Biopharmaceuticals, Biosimilars & ATMPs Wanted for different kind of vaccines, unwanted for a variety of complex Large Biological Entities (LBEs)
 

13-14 March, 2024, Virtual

Time Zone : UTC/GMT+1 /CET

 
GET THE AGENDA NOW

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Overview

 

With the increasing complexity of today’s therapeutics like Biologics, Biopharmaceuticals, Biosimilars & especially ATMPs, the unique issues have emerged especially in managing immunogenicity in clinical practice and during drug development. Understanding regulatory and quality requirements as well as applying the appropriate analytics and effective clinical monitoring to detect ADAs (Anti-Drug-Antibodies) are becoming essential for successful drug development & patient safety.

Distinct approaches to control ADAs & safeguard human subjects need to be considered. This unique course brings practical & in-depth understanding of immunogenicity in pre-clinical and clinical development, and brings clarifications on regulation, requirements, and quality concerns.

Join us to find solutions for your immunogenicity challenges and learn from case studies on mAbs, ATMPs & Biosimilars.

 

#masterclass     #pharmaonlinemasterclass      #glceurope      #globalleadingconferences       #immunogenicity

Trainer
Dr. Markus Fido
Dr. Markus Fido
Founder, Managing Director
Meridian Biopharmaceuticals, Austria
Mfi Bio-Consulting
Markus has more than 20 years of experience in pharmaceutical industry, with focus in vaccines, recombinant proteins, and immune therapeutics. He has profound expertise in regulatory aspects such as third-party audits, authority inspections and GMP guidelines.

He has a management consulting education and holds a doctorate degree in immunology/biochemistry from the Technical University of Graz, Austria. Markus started his carrier at a Novartis “Spin off” in Vienna in 2006, later on he has acquired the oncology division from Novartis and founded 2 Biotech companies VelaLabs & Meridian Biopharmaceutics.

Besides serving as a CEO and formal Managing Director, Markus has also taken responsibilities as a Head of Regulatory Affairs within the Quality Operations team.

Markus was previously Head Quality Control at Igeneon / Aphton Biopharma where he was responsible for all QC aspects of pre-clinical and clinical projects such as stability studies, specifications, method validation, and product release.

Before he was Group Leader of Immunology and Product Development at Biomin GmbH, Head Biochemical Control at Baxter AG and Head Quality Operations at Octapharma AG.

2 years Biomin AG
Lab Head, Cell culture lab, development of immune enhancer drugs

6 years Baxter Inc.
QC Manager, Quality control of vaccines & coagulation factors

2 years Octapharma AG
Head of Quality Operations & Quality Control

3 years Novartis AG
Head QC, Oncology, cancer immune therapy, product development of mAbs

15 years Management Buy-out VelaLabs & Meridian Biopharma
Founder & Managing Director of 2 Biotech companies

2020-now: Mfi Bio-Consulting GmbH
Founder & CEO, Consultancy & training

Products: Biologics, Biopharmaceuticals, Biosimilars, ATMPs, Monoclonals, Vaccines

Focus: Analytics, Quality Control, Process & Clinical Development, Regulatory Affairs Member
of advice team for ATMPs (ECA) and EMA Working Group

Who should attend imgRECOMMENDATION

Who should attend?


• Clinical trial manager

• Product development specialists

• CSO/COOs in Biotech industry

• Analytical development heads

• Members of QC departments

• Members for product analytics

• Clinicians & Principal investigators

• Personal from CROs

• R&D scientists for complex drugs

• Members of agencies & 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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10+

Years of experience

299

Events organized

3,410

Speakers

17,761

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