Regulatory Refresher & Updates

COURSE DETAILS

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

Normal Course Fee: $979
Early Bird Special: $929 (Before 19 September 2014)
Group (>3): $899

 

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This intense, interactive workshop provides an overview of the regulatory framework for clinical trials including ICH GCP plus the latest global developments and trends in GCP.

 

 


 THE PROGRAM

This course will focus on the global legal framework for GCP and the latest developments and trends in clinical trial regulations.  The course will focus on new developments over the last 2 years.  It is important to keep up with the latest requirements and developments in GCP, and how these are likely to impact clinical trials for both pharmaceutical companies and the study sites.  Regulatory inspectors expect those involves in clinical trials to be updated with recent developments in GCP – this workshop will be ideal for this.

 

COURSE OBJECTIVE

  • The latest developments in GCP globally and what can be expected in the future
  • Current Trends in Risk Adapted Approaches to clinical trial management 
  • The latest developments in clinical trial databases
  • Trial master files developments
  • Guidelines on Good Clinical Laboratory Practice
  • The Sunshine Act in the US.

 

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, CEO & Director, 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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Clinical Research Training

Following international standards is essential for a good clinical practice and will be the main regulatory focus behind these courses. The training is designed primarily for those fellows training for academic careers and is extensively into medical genomics, research management, statistical analysis and research design. There is a fast growing need of highly qualified clinical investigators who can participate actively in health services research and follow a good clinical practice.

The overall mission of clinical research training and GCP training is to proliferate the number as well as quality of clinical investigators. One can only achieve this by offering wide array of opportunities as well as the right training and meet the growing need of faculty, trainees and staff in different organizations. These courses focus on implementing knowledge for the participants in their day-to-day activities. The aim is to get a real return on your training investment by offering a unique training in this segment.

We value the outcome of the training as being the most important. Our aim is your goal: to get a real return on your training investment. These trainings are regularly updated to meet the current goals and meet the latest guidelines and information available.