Clinical Trials

Concorde Club, Southampton

Friday 5th March 2010

This seminar is designed to provide an insight into the history and application of relevant regulations and good practice guidance within clinical research, especially those governed by the Medicines for Human Use Act (clinical trials) 2004.  Delegates will be introduced to the principles of Research Governance and Good Clinical Practice and will be equipped with the skills to advise researchers on the good conduct of clinical research.  A combination of presentations and interactive workshops will be used.

Objectives: by the end of the day delegates will be

  • familiar with the regulatory aspects of conducting clinical research
  • conversant with the approvals systems of R & D, Ethics and the regulatory bodies, such as MHRA

Target Audience

A training seminar designed both for members of contract teams and for research managers.

Prior Knowledge Required

No prior knowledge necessary.

Presenters

Course team:

Dr Martina Prude - Head of Research Governance, University of Southampton

Dr Lindy Dalen - Research Governance Manager, University of Southampton

Ginny Hope - Insurance Services Manager, University of Bristol

Jo Miller - School Accountant, School of Medicine, University of Southampton

David Powell - Commercial Research Manager, Southampton University Hospitals NHS Trust

Paul Roberts -Quality Manager, School of Medicine, University of Southampton

Dr Gary Roper - Head of Regulatory Compliance, Imperial College, London

 


 

Programme
Price
Venue
Travel
Queries
Booking

Programme

0900       
Registration and Coffee (Club Room)
0930

Introduction to Regulation of Research - Martina Prude

1000 Insurance and Indemnity in Clinical Trials - Ginny Hope
1045 Coffee
1115 Contracts, Costing and Financial management of Clinical Trials - David Powell and Jo Miller
1215 Confidentiality and Data Protection - Lindy Dalen
1300 Lunch (with stands from NIHR, RDS and NHS IP Hub)
1400 Informed Consent - a practical exercise   Martina Prude
1445 Regulations and Required Approvals for CTIMPs and NHS Research - Gary Roper
1530 Afternoon Tea
1600 Human Tissue  Act - Lindy  Dalen and Paul Roberts
1630 Closing Questions and Summary of the Day - Martina Prude
1700 Close

Venue and Travel

The Concorde Club is in Eastleigh, just off the M27 and two minutes from Southampton airport and Southampton Parkway station.  The seminar will be held in the Main Club Room.

Overnight accommodation can be booked onsite at the Ellington Lodge Hotel (a 3* hotel adjoining the Club).  The hotel is in a quiet woodland setting adjacent to the Lakeside Country Park.   Delegates may book B & B for £85 pp per night.   Please note that room reservations should be made directly with the hotel (and not through ARMA) - please call 023 8065 1478 and quote ARMA seminar.

Travelling by car:

From the M3: at the end of the M3 southbound, take the M27 eastbound (signed Portsmouth), leave at the first junction (J5), at the roundabout take the first exit on to Stoneham Lane - the Club is 400 metres on the right hand side.

From the M27: Eastbound - leave at Junction 5. At the roundabout take the first exit on to Stoneham Lane.  Westbound - exit at Junction 5 and take the third exit for Stoneham Lane.

There is plenty of free parking at the Concorde Club.

The Club is only 15 minutes' walk from Southampton Airport and Parkway Station, but there is no footpath, so we would advise taking a taxi.

 

Location Map

Price

£215 ARMA members

£278 non-members* (which includes ARMA membership to 31st March 2011) - members joining groups this year, special conditions apply - please see below

The higher rate for non-members includes annual membership of ARMA for the period until 31st March 2011. For tax reasons, ARMA events are open to members only. If you are not yet a member, you will be able to join in the course of making your booking. If you are already a member please remember to log in before registering.

The seminar fee includes refreshments, a buffet lunch and a comprehensive delegate pack.  Overnight accommodation is not included but can be booked separately at the Ellington Lodge Hotel (see above).

Please read our Terms & Conditions before booking and be aware of our substitution policy.

Queries

For general queries relating to bookings, etc. contact Rosemary.

For specific queries relating to the event please contact Dr Martina Prude.

Booking

Booking is open now.

*Non-members wishing to join an ARMA institutional group in April should contact the ARMA office or their group co-ordinator before registering.