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Overview of workshop:

Biopharmaceutical products hold great promise in therapeutics because of their excellent targeting ability. This advantage is tempered with the danger of inducing an unwanted immune response in patients. This workshop is designed to provide a thorough understanding of the scientific and regulatory expectations to detect and characterize antibodies to therapeutic proteins. We will start with describing the biological mechanism responsible for immunogenicity and interpret the recommendations of major regulatory and industry documents. The workshop continues by demonstrating logical pathways to select, standardize and validate correct immunogenicity methods then execute sample analysis. The final section reviews strategic paths to evaluate risk and manage immunogenicity issues to not only be successful in the clinic but also throughout the entire life cycle of a drug. Case studies will be used throughout the workshop to demonstrate the various theoretical points.

Upon completion of this workshop, attendees should be able to:

  • Comprehend the biological basis for the immunogenic response to protein drugs
  • Comply with the current regulatory and industry expectations on immunogenicity testing
  • Develop and validate appropriate methods to detect and characterize antibodies
  • Correctly interpret immunogenicity data from pre-clinical and clinical studies
  • Contribute strategically to the immunogenicity Risk Management Plan throughout the life cycle of the drug
     

About the workshop host:

Ana T. Menendez, Ph.D., is Senior Director of Biotechnology at Catalent where she implemented the following services to support the biopharmaceutical industry: potency bioassays, PK/PD, immunogenicity and viral clearance. Dr. Menendez previously worked at Bristol-Myers Squibb where she headed the Cancer Cell Biology Department. From 1982 to 1995 she pioneered monoclonal antibody technology at Wyeth and was responsible for all the immunoassays and in vitro bioassays for Mylotarg, an anticancer monoclonal antibody - toxin conjugate that was approved in 2000. Dr. Menendez is an international speaker and course instructor on Immunogenicity and Bioassay Method Development and Validation.
 

About Catalent:

Catalent Pharma Solutions is a leading, global provider of advanced technologies as well as development, manufacturing and packaging services for pharmaceutical and biotechnological companies. Catalent offers analytical, bioanalytical and immunogenicity testing in addition to mammalian cell gene expression (GPEx®), protein manufacturing, method validation, stability studies, formulation development and regulatory consulting.

http://www.catalent.com
 

Workshop programme

12:30 Registration & Coffee

13:00 Welcome & Introductions

13:10 Fundamentals of Immunogenicity

13:45 Required Methods

14:30 Morning Coffee

15:00 Method Standardization

15:45 Risk Analysis

16:30 Discussion Session

17:00 Close of Workshop

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Crowne Plaza Hotel - St James

Buckingham Gate 45/51
London SW1E 6AF
United Kingdom

Crowne Plaza Hotel - St James

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WHAT IS CPD?

CPD stands for Continuing Professional Development’. It is essentially a philosophy, which maintains that in order to be effective, learning should be organised and structured. The most common definition is:

‘A commitment to structured skills and knowledge enhancement for Personal or Professional competence’

CPD is a common requirement of individual membership with professional bodies and Institutes. Increasingly, employers also expect their staff to undertake regular CPD activities.

Undertaken over a period of time, CPD ensures that educational qualifications do not become obsolete, and allows for best practice and professional standards to be upheld.

CPD can be undertaken through a variety of learning activities including instructor led training courses, seminars and conferences, e:learning modules or structured reading.

CPD AND PROFESSIONAL INSTITUTES

There are approximately 470 institutes in the UK across all industry sectors, with a collective membership of circa 4 million professionals, and they all expect their members to undertake CPD.

For some institutes undertaking CPD is mandatory e.g. accountancy and law, and linked to a licence to practice, for others it’s obligatory. By ensuring that their members undertake CPD, the professional bodies seek to ensure that professional standards, legislative awareness and ethical practices are maintained.

CPD Schemes often run over the period of a year and the institutes generally provide online tools for their members to record and reflect on their CPD activities.

TYPICAL CPD SCHEMES AND RECORDING OF CPD (CPD points and hours)

Professional bodies and Institutes CPD schemes are either structured as ‘Input’ or ‘Output’ based.

‘Input’ based schemes list a precise number of CPD hours that individuals must achieve within a given time period. These schemes can also use different ‘currencies’ such as points, merits, units or credits, where an individual must accumulate the number required. These currencies are usually based on time i.e. 1 CPD point = 1 hour of learning.

‘Output’ based schemes are learner centred. They require individuals to set learning goals that align to professional competencies, or personal development objectives. These schemes also list different ways to achieve the learning goals e.g. training courses, seminars or e:learning, which enables an individual to complete their CPD through their preferred mode of learning.

The majority of Input and Output based schemes actively encourage individuals to seek appropriate CPD activities independently.

As a formal provider of CPD certified activities, SMI Group can provide an indication of the learning benefit gained and the typical completion. However, it is ultimately the responsibility of the delegate to evaluate their learning, and record it correctly in line with their professional body’s or employers requirements.

GLOBAL CPD

Increasingly, international and emerging markets are ‘professionalising’ their workforces and looking to the UK to benchmark educational standards. The undertaking of CPD is now increasingly expected of any individual employed within today’s global marketplace.

CPD Certificates

We can provide a certificate for all our accredited events. To request a CPD certificate for a conference , workshop, master classes you have attended please email events@smi-online.co.uk

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