Short Course Announcement

SHORT COURSE ANNOUNCEMENT

GOOD CLINICAL PRACTICE (GCP) AND GOOD CLINICAL AND LABORATORY PRACTICE (GCLP) COURSE

Venue/Country: NIMR, Dar es Salaam

Collaborating Institutions

National Institute For Medical Research (NIMR) – Muhimbili and KAVI – Institute of Clinical Research in collaboration with support from Global Health Research Initiative

Introduction:

Are you are a Health Care Professional interested in Clinical Trials & Research? Would you like to build your capacity and means of delivery as a GCP practitioner? Enroll for our highly interactive GCP and GCLP training that will equip you with necessary skills and knowledge on how to carry out clinical research to the required international standards. The course will address the current regulatory framework for laboratory and clinic work in support of clinical trials with reference to the ICH Guideline for Good Clinical Practice, the Clinical EU Trials Directive and related regulations and guidance.

Who should attend?

Doctors, Nurses, community health workers Laboratory technologists and Managers, IT/Data Clerks and Managers, Research Assistants/Secretaries/Administrators, Principal and Sub Investigators, Clinical Trial/Study coordinators, Monitors and Auditors working in:

Pharmaceutical companies

Central laboratories

Contract Research Organizations

University-affiliated Hospitals

Medical Clinics

Research Organization/ Clinical sites staff

Post-graduate students (public health and clinical fields)

Treatment and Care programs

Objectives of the course are:

1.To Discuss and develop ideas on how best the GCP guidelines can be applied to ensure quality data is generated.

2.To solve specific problems related to clinical trials.

3.To Examine particular aspects of GCP in relation to their clinical research site set up .

4.Introduce participants to the concepts and applications of good clinical laboratory practice (GCLP).

5.Interpret Good Clinical Laboratory Practice guidelines within the broad laboratory framework in an acceptable fashion .

6.Outline practical steps of implementing guidelines into clinical trial laboratory settings

Benefits include:

Receiving guidance on the interpretation and application of GCP

Understanding how GPP (Community) fits within a clinical (GCP) program.

Receiving practical help on how to implement GCP and GCLP within a clinical research site.

Creating an opportunity to update your knowledge of GCP with the current interpretation of requirements

Guidance on the interpretation and application of GCLP within the framework of Good Clinical Practice (GCP)

Understand how GCLP fits within a clinical (GCP) programme

Access to an experienced panel of speakers

An opportunity to improve your understanding of the GCLP requirements as they are applied in different situation.

Training Methods:

1.Teaching will be in form of lectures,

2.Group Exercises. A certificate awarded upon successful completion of the course. Duration: 2-3 days

Please note: Registration and conference/training package = 50USD.

For further enquires please contact

NIMR –Muhimbili

P.O. Box 3436

Telephone: +255222152232

Fax: +255222150458

Email:, and .

The dates of GCP; 8 th– 9th July, 2014 and

GCLP; 10th to 11thJuly, 2014

How to apply:

Please apply through electronic application by (Dr Wanze Joyce), ( Dr G.S. Mfinanga) or . (Ms Ntuli Mwaigwisya)