Join NDA at SciLifeLab to hear Paul Chamberlain, Biopharmaceuticals & Immunogenicity Expert at NDAs Advisory Board, speak on anticipating and avoiding issues for biopharmaceutical development.
All biopharmaceutical products are associated with an intrinsic potential to induce immune responses in treated subjects. Regulatory agencies expect sponsors to evaluate and mitigate these risks during product development, applying a strategy that addresses product- and patient-related factors. Overall, understanding and controlling immunogenicity-related risks are attainable objectives, and approvability should not be compromised if these risks are suitably evaluated from the earliest stages of development.
Learning aspects:
- How to apply immunogenicity risk assessment at the lead candidate selection stage
- Minimizing incremental risks associated with manufacturing
- Understanding what and how to evaluate, at different stages of clinical development
- Integrated presentation of data to regulatory agencies
When: Tuesday 29th May 2018, 9:00-10:00am. Breakfast from 8:30amWhere: SciLifeLab (Air & Fire at ground floor), Tomtebodavägen 23 Solna, Sweden
The breakfast seminar will be an open and interactive workshop with the opportunity to ask questions to Paul. Specific questions can also be sent in advance to frukostseminarium@ndareg.com. Indicate if you would like to discuss them openly during the meeting; otherwise we can book separate meetings to discuss them after the seminar.
Registration: RSVP by Thursday 17th May 2018 to: frukostseminarium@ndareg.comContact: Lina Jansson, Marketing Associate, +46 (0)8 590 778 00, or email frukostseminarium@ndareg.com
The breakfast seminar is free. If you are unable to attend, please advise us no later than two days before the seminar.