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In association with ERT

The recent  regulatory directive requires prospective suicidality monitoring in every phase, in every protocol  and at every visit for many therapeutic areas.  This half-day workshop will guide you through the nuances of these new regulations and so that you will be better informed and prepared for future trial planning. Furthermore your expert workshop leaders will present methods to ensure that your safety monitoring meets the standards both in local and international clinical studies and the assessments you will need to employ.

What you will learn from this half-day workshop:

  • What the directive for prospective Suicidality Monitoring entails and the latest regulatory updates
  • What experts have already learned about monitoring patient behaviour in this area
  • How to address these new regulatory requirements
  • How to evaluate the right approach for your trial

About the Workshop Leaders:

 

Dr Alan J. Gelenberg, MD, President and CEO, Healthcare Technology Systems

·         Clinical Professor of Psychiatry, University of Wisconsin

·         Professor Emeritus of Psychiatry, University of Arizona

Since 1987 Dr. Gelenberg has been Editor-in-Chief of the Journal of Clinical Psychiatry, the world’s most widely read peer-reviewed psychiatry journal. He is also founding author of Biological Therapies in Psychiatry Newsletter, in its 31st year. For 18 years, he was Professor and Head of the University of Arizona’s Department of Psychiatry, where he is now Professor Emeritus. Previously, Dr. Gelenberg was on the faculty of Harvard and Massachusetts General Hospital for 19 years. He was also on the M.I.T. faculty.
 

 

 

 

 

 

 

 

 

Michael Federico, MS Eng, Vice President, ePRO Solutions, ERT
Michael is responsible for managing all aspects of the ePRO Solutions suite at ERT, including product development, operations, and sales. The ePRO group has organized ERT’s capabilities into products and services to provide the complete patient experience from recruiting right through to suicidality monitoring. Prior to joining ERT six years ago, Michael spent over 20 years in systems design, evaluation, and equipment management in the healthcare field. He holds Bachelors and Masters Degrees in Engineering from Rensselaer Polytechnic Institute, in Troy, New York.

 

Peter Bennett, Product Specialist, ePRO Solutions, ERT
Peter joined ERT in January 2006 as Associate Director, Business Development. During his time at ERT he has worked successfully across Europe and the Middle East in both the cardiac safety and ePRO sectors, selling complex technology solutions to the pharmaceutical and biotechnology industries. Peter’s aptitude for new ideas and approaches led to him assuming Business Development responsibility for ERT's ePRO Solutions for Europe in April 2008. Since then he has worked extensively with ERT's ePRO partner Healthcare Technology Systems helping to develop and deliver IVR ePRO solutions via ERT's EXPERT ePRO system.

About ERT:

ERT (www.ERT.com) is a provider of centralized core-diagnostic electrocardiographic (ECG) and electronic patient reported outcome (ePRO) solutions to the global biopharmaceutical and medical device industries. The company is the global leader in Cardiac Safety and it provides sponsors and CROs with patient self-report solutions that improve the complete patient experience from recruitment and screening to data capture and safety

Workshop programme

13:30 Welcome and Introduction

13:40 A Regulatory View of Suicidality in FDA Trials

Alan Gelenberg

Alan Gelenberg, President and CEO, Healthcare Technology Systems LLC

14:20 Columbia-Suicidality Severity Rating Scale: Development and Uses

Peter Bennett

Peter Bennett, Director Business Developement, ERT

15:00 Coffee Break

15:10 Computer Automation to Facilitate Suicidality Severity Monitoring and Alerting

Peter Bennett

Peter Bennett, Director Business Developement, ERT

15:50 Lessons from Research: What Do You Do when a Patient Tells a Computer They Are Suicidal?

Alan Gelenberg

Alan Gelenberg, President and CEO, Healthcare Technology Systems LLC

16:30 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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