Monoclonal Antibodies Quality & Regulatory Requirements
Hosted by Fleming
- 13 – 14 October 2026
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Key facts
Monoclonal Antibodies Quality & Regulatory Requirements is a seminar held 13 – 14 October 2026 in Vienna, Austria, organised by Fleming.
- Dates:
- 13 – 14 October 2026
- Format:
- Hybrid (in person and online)
- Venue:
- Vienna, Austria
- Subjects:
- Pharmacy & Pharmaceutical Sciences
- Organiser:
- Fleming
- Official website:
- fleming.events/monoclonal-antibodies
Organised by Fleming, the Monoclonal Antibodies Quality & Regulatory Requirements course takes place in Vienna, Austria and via Online Live Stream on 13 - 14 October 2026. This unique event provides comprehensive training on the regulatory landscape, process characterisation, validation, and lifecycle management for monoclonal antibodies. Distinctive features include interactive discussions, individual consultancy with the trainer, practical case studies, and a certificate of completion.
Topics
- Regulatory landscape for mAbs 2026
- Process characterisation and process validation
- Comparability protocols and management of process change
- Process control strategy development for clinical and commercial processes
- Analytical product profile and implementation of ICH Q14
- Process qualification, continuous process verification and technology transfer
- Regulatory considerations during product lifecycle
- Antibody Drug Conjugate and bispecific antibodies additional considerations
- Glycosylation of mAbs – Fc & Fab-related effects after manipulation
- Examples & case studies for different product types & challenges
Who should attend
Professionals in pharma, QA, regulatory affairs, CMC teams, and biosimilar developers working with monoclonal antibodies, ADCs, or bispecific antibodies.
Keynote speakers
View speakersRichard Francis - Principal Consultant, UK
Organiser and contact
Contact
- Event secretary:
- Karthik Naik
- Email:
- [email protected]
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