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EPharma Global

EPharma Global

EPharma Global

Pharmaceutical Training for Individuals

What can we do for you?

We provide you with access to bespoke accredited on-line training courses that provide you with the skills that are needed to enter the Pharmaceutical/Biotechnology Industries.

Our courses are accessible from any platform at any time. Once enrolled the courses can be completed at your own pace within one year.

Our on-line courses have been designed by experts in the field of Clinical Research in the leading Pharmaceutical and Biotechnology companies across the world.

You will receive a certificate following completion of each course which is certified by ePharma-Global as well as CPD (Continued Professional Development- UK).

Why are these courses needed?

  • We are competing with a Global Market of Graduates
  • Experience and Training is extremely difficult to gain
  • We have learnt that knowledge and skills is everything.

By completing our courses you will be several steps ahead with an indepth understanding of the course you’ve attended and the particular role you are interested in.

Pharmaceutical Industry as a Career?

The pharmaceutical industry boasts some of the most influential and richest companies in the world.

The annual turnover for last year was 700 billion dollars that is $100 for each person on this planet. It is expected that this revenue will grow by 2020 to $1.3 trillion dollars.

SEE Roles within the Industry below

Taking the Training?

  • Courses can be taken at an individuals own pace.
  • Payment is taken through a highly secure gateway of PayPal Pro.
  • Our LMS system is simple to use and is one of the most innovative and extensible platforms in the LMS industry.
  • Our training courses are accessible from all device types

Clinical Trial Administrator

  • Involved in the review of essential documents to ensure sponsor and investigator obligations are being met and in compliance with local regulatory requirements and ICH guidelines
  • Providing data as required for clinical operations performance and project status metrics
  • Providing status reports to clients

 

Clinical Research Associate

Clinical Research Associate

  • Create study-specific monitoring guidelines & study tools; writing newsletters
  • Protocol development
  • Preparing ethics submissions and facilitating scientific review submissions
  • Preparation and management of investigator budgets and study agreements
  • Oversight/Management of vendors including central laboratories, central imaging, interactive voice response systems and translation

 

Clinical Project Managers

  • Ensure global trials are delivered within budget, schedule and according to quality standards, SOPs and contract specifications
  • Responsible for coordinating appropriate training of clinical team in the therapeutic area and understanding of protocol requirements
  • Write clinical management plans and patient recruitment plans
  • Review protocols at concept stage assist in further development to fully signed protocol for implementation
  • Organise and present at investigator meetings
  • Set-up and manage independent Data Safety Monitoring Committees

 

Pharmacovigilance Associate

Compliance Training

Also known as
Medical Information Scientist

  • Global adverse event management for pharmaceutical and medical device trials
  • Collection, evaluation, analysis, and reporting of safety information, including serious adverse events, unanticipated adverse device effects,and other significant safety events
  • Safety narrative writing, coding of adverse event information
  • Assessment and evaluation of reportability and submission of reportable events to global regulatory authorities.
  • Preparation and submission of annual safety reports, biannual line listing, and periodic reports to global regulatory authorities
  • Preparation of post-marketing surveillance reports, including periodic safety update reports (PSURs)

 

Good Clinical Practice

Clinical Research Associate

 

  • Learn about Good Clinical Practice with a detailed historical perspective
  • The influence of the Clinical Trials Directive on Good Clinical Practice
  • Details of the Good Clinical Practice Directive (2005/28/EC)
  • Understand the 13 principles of GCP
  • Learn about Source Data, the Informed Consent Process and essential documents for a clinical trial
  • Ethics Committees and Submissions; IRB's & Submission process (USA)
  • Understand the ICH Responsibility of Investigator and Sponsor
  • Understand Adverse Events, Serious Adverse Events and Unexpected Adverse Events

Preparation of a response to an Audit Report

 

Clinical Quality Assurance Auditor

  • Why are Audits Necessary
  • What are the Key Questions Raised
  • Who are the Key Contributors
  • Establishing a Root Cause
  • Corrective Preventative Action Plan
  • Detailed Audit Responses
  • What is an Acceptable Response
  • A Checklist for Audit Responses
  • Levels of Observations in Audits
  • Examples of Corrective Action Plan
  • Examples of Preventative Action Plan
CPD LogoREC Member

Pharmaceutical Training’ in Clinical Research for:
Science and Nursing graduates/post graduates to train as Clinical Research Associates (CRA), Clinical Project Managers (CPM), Pharmacovigilance Associates (Drug Safety) and to gain knowledge in Good Clinical Practice and Audit Preparation and Response