Regulatory Refresher & Updates_Corporate

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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;
  • Risk adapted approached to clinical trial management in UK and US;
  • The latest developments in clinical trial databases;
  • Trial master files developments;
  • Guidelines on Good Clinical Laboratory Practice;
  • Trial master files developments;
  • 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

 

 


 

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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.