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In association with Verdani AG
www.verdandi.ch

 Overview of workshop

This half-day workshop is focussed on the interface between GMP and GCP in clinical trials, namely the handling of IMP at clinical sites.  Once the IMP has left the GMP facilities and arrived at the clinical trial site, the responsibility for proper handling of IMPs rests with the investigator.  Adequate storage, handling, reconstitution, administration and reconciliation of study medication is crucial to ensure that reliable information is gathered regarding the trial subjects' exposition to the IMP.  However, this is also an area where problems are often observed.  Delegates will learn about the regulatory requirements for handling IMP at the clinical trial site and also get an overview on deficiencies observed during audits and inspections. The workshop will be interactive and offer many opportunities to share information and best practice towards compliance.

About the workshop leader

Rita Hattemer-Apostel has been working in the field of Quality Assurance and GCP compliance since 1994.  Rita has worldwide experience in auditing clinical trials and systems and regularly conducts GCP mock inspections to help sponsors and investigator sites prepare for regulatory inspection. She also supports clients in developing adequate SOP and QA systems and has conducted numerous seminars and training sessions on various GCP/QA-related topics.

From 2003 to 2009, Rita served as President of the Swiss Professional Association of Quality Assurance (SPAQA).  She is an active member of many industry associations in pharmaceutical medicine, GCP and QA.  Since 2004, Rita has been Editor-in-Chief of the Quality Assurance Journal.  She is currently editing the 3rd edition of the book 'GCP Auditing' which will be published in autumn 2010.

Rita graduated in physics engineering (MSc) at the University of Applied Sciences in Wiesbaden, Germany, and her education includes language studies, certification as Quality Manager and studies in organisational psychology and coaching. 

About the organisation

After positions in pharma and CRO industry, Rita Hattemer-Apostel founded Verdandi AG in 2000.  Verdandi is an independent Quality Management Consultancy and assists clients with GCP consulting, training and auditing services on a worldwide basis.  Our goal is to identify weaknesses and gaps in clinical trials and systems and to trigger activities which improve compliance and effectiveness.  Apart from routine audits for clinical trials, Verdandi has been contracted for pre-inspection audits and GCP mock inspections and has a strong track record for systems audits.  Many clients have been trained in customised seminars and have benefited from Verdandi's assistance in developing and shaping their processes for increased efficiency and compliance.

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 Who should attend

  • Members of Clinical Research & Development and Clinical Operations departments
  • Clinical Project Directors, Clinical Trial Managers, Clinical Research Associates, Study Assistants
  • Quality Assurance Auditors, GCP and GMP Auditors
  • Staff responsible for clinical trial logistics
  • Clinical investigators, site staff and pharmacists

Workshop programme

8:30 Registration and coffee

9:00 Welcome and introductions

9:10 The Theory: GCP/GMP requirements for IMPs

10:10 Morning coffee

10:30 The Reality

11:30 Discussion session

12:00 Close of workshop

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Marriott Hotel Regents Park

128 King Henry’s Road
London NW3 3ST
United Kingdom

Marriott Hotel Regents Park

This 4 star north London hotel in zone 2 is the perfect destination for the astute business traveler as well as the leisure guest that knows how convenient north London hotels are, as a base from which to explore the city .Bond Street is just 3 stops from Swiss Cottage underground station on the Jubilee Line, so you can be shopping, exploring the sights and taking in one of London’s world-renowned West End shows in less than 15 minutes when you stay at this hotel near central London. At the same time, the hive of activity that is Camden Town, the chic shops, cafes and restaurants of Primrose Hill and ZSL’s London Zoo in Regents Park are all just a short walk from this hotel in north London.

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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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