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Processes & Effects of Immunogenicity to Biologics & the Screening Methodologies - 3 hour Virtual Training

ComplianceOnline

Wednesday, January 11, 2017 from 10:00 AM to 1:00 PM (PST)

Processes & Effects of Immunogenicity to Biologics &...

Ticket Information

Ticket Type Sales End Price Fee Quantity
One Dial-in One Attendee Jan 11, 2017 $429.00 $0.00
Group-Max. 10 Attendees/Location Jan 11, 2017 $999.00 $0.00
RECORDED VERSION Jan 11, 2017 $479.00 $0.00
TRAINING CD Jan 11, 2017 $579.00 $0.00

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Share Processes & Effects of Immunogenicity to Biologics & the Screening Methodologies - 3 hour Virtual Training

Event Details

This 3 hour virtual training will provide an overview of the concepts and types of immune responses elicited by biologics. The factors contributing to immunogenicity and impact on efficacy and safety will be identified. Validated screening and confirmatory methods that measure an immune response to a biologic during the various stages of development, clinical studies and post-approval surveillance will be discussed.

Why Should You Attend:

Immune responses in the patient population during clinical trials or post-market are a serious issue facing biologic therapeutics. Regulatory agencies expect biopharmaceutical/pharmaceutical companies to fully assess the potential for immunogenicity in large molecule therapeutics. Understanding agency expectations should allow a reasoned and risk-based approach to assessing potential problems with immunogenicity.

This webinar will provide a general overview of immunogenicity while also addressing specific topics on development and validation. Included in the discussion are understanding and establishing the initial screening method and method to assess neutralizing antibodies.

 

Learning Objectives:

  • Understanding expectations for testing for immunogenicity
  • Understanding the impact of immunogenicity
  • Designing a solid strategy to assess immunogenicity
  • Developing a method suitable for validation
  • Designing the validation protocol
  • Selecting an appropriate cut-point
  • Testing samples
  • Confirmatory methods
  • Checking for neutralizing antibodies
 

Areas Covered in the Webinar:

  • Method Development Strategies
  • Validating the methods
  • Risk-based approach
  • Data analysis during sample analysis
  • Confirmation assays
  • Importance of pre-clinical data
  • Problems and pitfalls to avoid
 

Who Will Benefit:

  • Executive management
  • R&D investigators
  • Product development
  • Validation Scientists
  • Pre-clinical and clinical
  • Regulatory affairs
  • QA/ QC
  • Consultants
  • Training

Instructor Profile:

Gwen Wise-Blackman has 20 years of combined experience in Cell-Based Assays and Quality Systems. She has worked at DuPont Pharmaceuticals, Catalent Pharma Solutions (formerly Magellan Laboratories and Cardinal Health), and Salix Pharmaceuticals. Her focus has been in High-Throughput Screening, Cell-Based Assay Method Development and Validation, Immunogenicity, Technology Transfer from client sites, and Quality Assurance. Dr. Wise-Blackman has a Bachelor of Science degree in biology from M.I.T and a PhD in Pharmacology from the University of Virginia. She is a member of ASQ and AAPS.

 

 

 

For Registration - http://www.complianceonline.com/process-effects-of-immunogenicity-to-biologics-and-the-screening-methodologies-webinar-training-705019-prdw?channel=eventbrite

Note: Use coupon code NB5SQH8N and get 10% off on registration.

 
Have questions about Processes & Effects of Immunogenicity to Biologics & the Screening Methodologies - 3 hour Virtual Training? Contact ComplianceOnline

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When & Where

Online Event
Palo Alto, California

Wednesday, January 11, 2017 from 10:00 AM to 1:00 PM (PST)


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Organizer

ComplianceOnline

Enhancing global compliance, creating a world where quality and compliance professionals, regulators, and government agencies come together to help the world comply with the intent and the spirit of laws, policies and mandates, ensuring continuous improvement in global operations, quality & safety.

Making sure that we are responsible corporate citizens helping our constituents build a more responsible enterprise, one which operates with high quality , under a code of ethics, and with process discipline to ensure greater shareholder returns.

Keeping things simple and straight forward , so that we all can indeed improve the quality of our processes, our work, our businesses and enhance compliance globally.

Being inclusive, giving the process experts ( & novices! ), compliance professionals, quality champions, and regulatory agencies a voice so that all of us can contribute and make a difference.

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Processes & Effects of Immunogenicity to Biologics & the Screening Methodologies - 3 hour Virtual Training
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