Home
overview

In Association with:

In Vitro Diagnostic Multi-variate Index Assays (IVDMIAs) are a new class of diagnostic test.  It is predicted they will alter the healthcare system and dramatically change the way the FDA regulates devices.  In the two years since Agendia succeeded in getting the first IVDMIA approved by the FDA much confusion has arisen surrounding the FDA’s guidelines for these devices.  This workshop, hosted by one of the regulators instrumental in Agendia’s success, aims to help dispel some of this confusion and make it possible for other regulators to succeed in getting approval for their devices.

Key Objectives:

• GAIN a better understanding of the regulatory environment surrounding IVDMIAs
• LEARN from the regulator involved in the first IVDMIA FDA approval
• UNDERSTAND the common pitfalls and how to overcome them

About the Workshop Leader:

Guido Brink serves as the Director of Quality Management, Regulatory Affairs for the Amsterdam and Huntington Beach-based diagnostics company, Agendia, a world leader in gene expression analysis-based diagnostics.  One of the five pioneers when the company was founded, Brink is also responsible for Agendia’s reimbursement activities worldwide.

In 2007, under Brink’s guidance, Agendia obtained the first U.S. Food and Drug Administration (FDA) clearance ever issued for an in vitro diagnostic multivariate index assay (IVDMIA) for the company’s 70-gene breast cancer prognostic test, MammaPrint™.  Based on his successful implementation of quality systems, Mr. Brink was asked to assist the Agency in the development of the Special Control Guidance Document (SCGD) for breast cancer testing in the U.S.  

Also under Brink’s supervision, Agendia became the first microarray laboratory in the world to acquire an ISO 17025 accreditation – a global standard used by testing and calibration laboratories. He also oversaw the accreditation of Agendia’s laboratory from the U.S. College of American Pathologists (CAP) and the U.S. Government under the Clinical Laboratory Improvement Amendment (CLIA).

In addition to overseeing quality control, regulatory affairs and global reimbursement for Agendia, Brink managed the company’s information and communication systems.  He is responsible for the development of MammaPrint’s sampling, preservation and transport system for tissue at room temperature, as well as the implementation of the automated ordering and reporting systems available through the company’s website.

About the Organisation:

Agendia is committed to improving the quality of life of people suffering from cancer through enabling effective personalized medicine. The company is pioneering the development and commercialization of validated tests that assist healthcare professionals and pharmaceutical companies to determine the diagnosis, prognosis and therapeutic responsiveness of cancers in individual patients.

In 2004, Agendia became the first company to commercialize a prognostic test that predicts the risk of breast cancer recurrence (MammaPrint). In 2007, MammaPrint became the first in vitro Diagnostic Multivariate Index Assay (IVDMIA) to acquire clearance from the US Food and Drug Administration (FDA). Agendia recently presented its new colon cancer prognosis profile, ColoPrint, which is currently undergoing further validation in the anticipation of developing a test to predict the likelihood of the cancer spreading at an early stage in the disease.

Workshop programme

13:30 Registration & Coffee

14:00 Welcome and Introductions

14:10 REGULATORY BASICS FOR MEDICAL DEVICE REGULATION

14:20 HISTORY AND FUTURE OF IVDMIA REGULATION BY FDA

14:50 PITFALLS FOR SUCCESSFUL IVDMIA CLEARANCE

15:20 Afternoon Tea

15:40 CASE STUDY: MAMMAPRINT

16:10 REIMBURSEMENT OF IVDMIA IN US

16:40 DISCUSSION

17:00 Close of Executive Briefing

+

Crowne Plaza Hotel - St James

Buckingham Gate 45/51
London SW1E 6AF
United Kingdom

Crowne Plaza Hotel - St James

HOTEL BOOKING FORM

Title

SubTitle
speaker image

Content


Title


Description

Download


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

Event Title

Headline

Text
Read More

I would like to speak at an event

I would like to attend an event

I would like to sponsor/exhibit at an event

SIGN UP OR LOGIN

Sign up
Forgotten Password?

Contact SMi GROUP LTD

UK Office
Opening Hours: 9.00 - 17.30 (local time)
SMi Group Ltd, 1 Westminster Bridge Road, London, SE1 7XW, United Kingdom
Tel: +44 (0) 20 7827 6000 Fax: +44 (0) 20 7827 6001
Website: http://www.smi-online.co.uk Email: events@smi-online.co.uk
Registered in England No: 3779287 VAT No: GB 976 2951 71




Forgotten Password

Please enter the email address you registered with. We will email you a new password.