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SMi is proud to announce the return of the 2nd annual Clinical Trial Documentation Management masterclass in 2016!

Good records management not only has an impact on how effectively an organisation manages its records during the conduct of a clinical study; well-managed clinical study records are critical to demonstrating compliance with GCP and other applicable regulations, as well as supporting regulatory inspections.

Once a clinical study is completed, the clinical study records are the primary - and often the only - evidence of clinical study activities, which are critical to permitting evaluation of the conduct of the study and the quality of the data produced.

Through interactive discussions and group activities, this full-day master-class will outline

  •  Regulations relating to Trial Master File, including best practice guidance and the latest thinking from legislators and regulators
  •  How clinical study records can be created and managed in both the immediate- and long-term to ensure the timely availability of an inspection-ready TMF

Attending this workshop will enable you to:

  • understand the requirements for clinical study records
  • comprehend how records can be managed more effectively
  • learn how to make best use of clinical study records to enhance information sharing and facilitate more efficient operations
  • improve inspection – readiness to avoid resource-intensive preparations when notified of impending audits and inspections

Masterclass LEADER

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Russell Joyce

Director, Heath Barrowcliff Consulting

Russell Joyce has over 20 years’ experience in records management across a wide variety of industries (including pharmaceuticals) both as a practitioner and consultant. He is a Director of the Scientific Archivists Group, Co-Lead for the SAG GCP Special Interest Group, and former Executive Committee Member of the Good Clinical Practice Records Managers Association, promoting latest developments, trends, industry best practices and standards in the life sciences sector. Russell has spoken extensively on records management issues for both these groups as well as for the Drug Information Association and the Institute of Clinical Research.

Heath Barrowcliff Consulting

Heath Barrowcliff Consulting Limited is a fully independent consultancy established to provide impartial quality advice and services in relation to archives, records and information management, information governance and commercial records storage. The consultancy delivers practical, user-friendly advice that enables clients to create, organise, maintain, retrieve and (re-)use information in a financially and operationally cost efficient manner that best meets their specific needs, maximises the value of information, and at the same time ensures compliance with all applicable statutory and regulatory requirements.

Russell Joyce has over 20 years’ experience in records management across a wide variety of industries (including pharmaceuticals) both as a practitioner and consultant. He is a Director of the Scientific Archivists Group, Co-Lead for the SAG GCP Special Interest Group, and former Executive Committee Member of the Good Clinical Practice Records Managers Association, promoting latest developments, trends, industry best practices and standards in the life sciences sector. Russell has spoken extensively on records management issues for both these groups as well as for the Drug Information Association and the Institute of Clinical Research.

Masterclass programme

9:00 Registration & Coffee

9:10 Topic Heading 1

9:15 Masterclass Leader Welcome & Introduction

Russell Joyce

Russell Joyce, Director, Heath Barrowcliff Consulting

9:30 Overview of Documentation Requirements

10:45 Morning Coffee

11:00 The TMF Reference Model

12:00 Networking Lunch

13:00 Electronic Record Requirements

14:00 Inspection Requirements and Expectations

14:45 Afternoon Tea

15:00 Archiving

16:00 Group Discussion

16:30 Masterclass Leader’s Closing Remarks and Close of Workshop

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Supporters

VENUE

Holiday Inn Regents Park

Carburton Street, London, London, United Kingdom

Choose the well-connected Holiday Inn London-Regent's Park hotel, with a superb central London location and speedy transport links. Holiday Inn London-Regent's Park is in a leafy and cosmopolitan area of central London, a 10-minute walk from bustling Oxford Street. Leave your car in our NCP managed underground car park, and explore London by Tube. Great Portland Street Tube station is 25 metres from the hotel, from where you can reach the City and Canary Wharf in 30 minutes, and London Heathrow Airport in 45 minutes.

Wireless Internet is available throughout the hotel, and you can invite up to 300 people to events at the Academy Conference Centre, with an IT technician and break-out zones. Holiday Inn London-Regent's Park is a 10-minute walk from Santander's offices and businesses in the BT Tower. Stroll 5 minutes to Regent's Park, where you'll find London Zoo and pretty Primrose Hill. We're a 10-minute walk from Bond Street boutiques and 20 minutes from Buckingham Palace and cruises on the River Thames.

Ask our Concierge to plan your day out and book West End theatre tickets. Room Service is available 24 hours at Holiday Inn London-Regent's Park, or dine in the vibrant Junction Restaurant. Our Junction Bar has a menu of light bites, and a hot breakfast buffet is served daily.

HOTEL BOOKING FORM

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Media Partners


Pharmaceutical Technology

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http://www.pharmaceutical-technology.com

Pharmaceutical-technology.com is the only website focusing specifically on issues relevant to pharmaceutical professionals working with technology, be it development, engineering, IT or production. Pharmaceutical-technology.com brings you the latest in industry projects and updates, along with the news, views and trends that leading professionals – from senior executives to manufacturing managers and heads of procurement – require to stay on top of their field.


Drug Development Technology

Supporters
http://www.drugdevelopment-technology.com

Drugdevelopment-technology.com covers every aspect of the drug development and research process, from conception to pre-FDA approval. Our global network of journalists updates the site with the latest and most significant industry developments. This coverage allows us to provide everyone - from senior management through to research and QA staff – with in-depth reviews of the latest projects, advance notice of new product releases and analysis of the latest procedural and legislative developments.


Pharmavision

Supporters
http://www.pharmavision.co.uk

PharmaVision offers a consultancy service providing independent pharmaceutical thematic research to the healthcare industry, the investment community and competitive intelligence specialists. We perform due diligence research and provide expert commentary in healthcare. Our reports combine scientific analysis in drug delivery, R&D technologies and pharmaceutical products including patient modelling, product/technology forecasts and market trends evaluation.

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Holiday Inn Regents Park

Carburton Street
London W1W 5EE
United Kingdom

Holiday Inn Regents Park

Choose the well-connected Holiday Inn London-Regent's Park hotel, with a superb central London location and speedy transport links. Holiday Inn London-Regent's Park is in a leafy and cosmopolitan area of central London, a 10-minute walk from bustling Oxford Street. Leave your car in our NCP managed underground car park, and explore London by Tube. Great Portland Street Tube station is 25 metres from the hotel, from where you can reach the City and Canary Wharf in 30 minutes, and London Heathrow Airport in 45 minutes.

Wireless Internet is available throughout the hotel, and you can invite up to 300 people to events at the Academy Conference Centre, with an IT technician and break-out zones. Holiday Inn London-Regent's Park is a 10-minute walk from Santander's offices and businesses in the BT Tower. Stroll 5 minutes to Regent's Park, where you'll find London Zoo and pretty Primrose Hill. We're a 10-minute walk from Bond Street boutiques and 20 minutes from Buckingham Palace and cruises on the River Thames.

Ask our Concierge to plan your day out and book West End theatre tickets. Room Service is available 24 hours at Holiday Inn London-Regent's Park, or dine in the vibrant Junction Restaurant. Our Junction Bar has a menu of light bites, and a hot breakfast buffet is served daily.

HOTEL BOOKING FORM

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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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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
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