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EPharma Global

EPharma Global

EPharma Global

Pharmaceutical Training for Organisations

We are a One Stop Shop addressing your training needs:

Organisational trainingWe train your staff on accredited courses to ensure that they are able to work effectively in the role of Clinical Trial Administrators, Clinical Research Associates, Clinical Project Managers, Pharmacovigilance Associates and Medical Information Scientists and in compliance

Following training we also offer a Q & A session within 7 days of completing the courses where your staff or yourselves are able to dial into a TC with us to discuss any questions you may have following your training on our certified courses.

Once registered your company will immediately gain access not just to your specific course but to our free courses.

Free courses are exclusively available only to those registered with ePharma Global

Your staff will learn about global issues as our experts will add new free courses regularly addressing and discussing key issues for example- ‘Changes in the Russian Law and Implications on Clinical Research.

Why are these courses needed?

  • Training is crucial for the development and success of your organisation
  • We ensure GCP compliance across your organisation
  • Train your staff to become more productive and efficient
  • Enhance your staffs skills, capabilities and knowledge
  • Ultimately cost savings for your organisations

We have learnt that knowledge and skills is everything in this Industry

As well as training in the role of interest and learning about specific issues which only working within the Industry your staff will learn, they will also develop key transferable skills such as

  • adaptability and flexibility
  • problem solving
  • Communication within the Industry
  • analysis and reporting
  • critical analysis

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