Advanced Good Clinical Practices

COURSE DETAILS

17,18 November 2014, Singapore 9.00am - 5.00pm (Reg. from 8.30am)
Singapore

Normal Course Fee: $1699
Early Bird Special: $1499 (Before 19 September 2014)
Group (>3): $1349

 

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GCP or Good Clinical Practice is a global guide and standard that works for the protection of human rights and the safety of humans in clinical research and trials. GCP training offers the right preparation so as to assure the safety and efficiency any newly developed compounds and the quality of data that is acquired.  A good clinical practice works on the roles and responsibilities of investigators and sponsors.

 Importance of GCP training. GCP is compilation of regulations and laws. In order to understand the complete compliance of the guidelines with all requirements, one needs to  get the right GCP training to understand all the requirements that control human subject research. This intense, interactive workshop covers more advanced Good Clinical Practice topics including common findings experienced in clinical trials in depth and how to overcome and prevent them.

 

THE PROGRAM

This course will focus on the common issues observed in clinical trials.  Each topic will be covered in detail and go beyond what is written in the guidelines and laws to what is expected of the sponsor by an inspectorate.  The course features many good practices and current trends in the conduct of clinical research at an advanced level.  The course combines theoretical and interactive sessions to maximise the impact of the learning for each participant.

 

COURSE OBJECTIVE

  • The most common findings in Health Authority GCP inspections;
  • What clinical trial processes should be covered by SOPs;
  • The impact and principles of good vendor oversight;
  • Optimal management of IMP;
  • How to avoid Ethics Committee issues;
  • The best practices in obtaining informed consent;
  • How to assess good oversight by a Principal Investigator;
  • How to minimise safety issues;
  • Measures to protect confidentiality of clinical trial subjects;
  • Ensuring data quality by enhancing data management systems.

 

WHO SHOULD JOIN

  • Clinical Research professionals and associates
  • Clinical Scientist / Basic Scientist
  • Clinical Investigators / Principal Investigators
  • Experienced Clinical Quality Assurance Professionals
  • Project Managers
  • Clinical Study Coordinators
  • Professionals in Clinical trials

 

TRAINER

Ms Trish Parry
BSc (Hons), FICR, CSci, Director & CEO, Otus Clinical Services Ltd

Trish Parry has 30 years experience in the pharmaceutical industry and 23 years experience in clinical research. Trish has extensive experience in global monitoring and International clinical project management as a result of working in multi-national pharmaceutical companies including Genzyme, US Bioscience and Allergan and clinical research organisations including Quintiles. She has set up and maintained the European Clinical Quality and Training Department in Allergan and she is an experienced trainer in clinical research and GCP.

Trish is author of Statistics in Clinical Research (The Institute of Clinical Research, 2004, UK) and is on the Editorial Board of the UK based Institute of Clinical Research’s Journal, CRFocus. Trish is one of the founders of the UK based Institute of Clinical Research Trainers Forum. Read More

 


 

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