Academy

Training Courses at HERAX

HERAX offers high quality training for employees and IT professionals working within or for the pharmaceutical industry. We have more than 20 years of experience working in the international pharmaceutical industry with pharma business process improvements and IT system implementations.

Who can attend?

HERAX offers training courses for professionals on different levels; from the person who just started working within the pharmaceutical industry in Clinical Development or IT to the person who has a lifelong career in the industry and wants to be able to manage projects better and go deeper into improving the clinical business processes and learning from projects and colleagues.

Available Courses

Pharma Introduction
Pharma Business – IT Project Management
Pharma Introduction

Introduction to the pharmaceutical business processes, from discovery to post marketing and sales. This course is teaching the fundamentals about the pharmaceutical industry, how a product is discovered, developed, tested and marketed. The course includes all the development and administrative processes making up a pharmaceutical company. The types of roles involved in developing a new drug and the necessary regulatory framework are all explained in detail.
In addition, we will go through all the IT systems that support the business processes used in Clinical Development, such as a Clinical Trial Management System, Electronic Data Capture, Safety Systems, Regulatory Management Systems, electronic Trial Master File, Statistical Analysis Environment, and Clinical Data Warehouse.
The course also covers how the clinical data standards (CDISC) are applied to the business in order to improve the collection, analysis and reporting of clinical data.

Content
  • Drug Development History
  • Drug Development Overview
  • Product Life Cycle
  • Production and Logistics
  • Discovery and Pre-Clinical
  • Regulatory Overview
  • Introduction to ICH (GxP)
  • Quality Management
  • Pharma IT Systems (e.g. EDC, CTMS)
  • Investigational Medicinal Products
  • Clinical Trial Phases
  • Clinical Trial Planning and Design
  • Clinical Trial Execution
  • Data Management
  • Trial Analysis and Reporting
  • Drug Safety Regulations and Responsibilities
  • Drug Safety Reporting
  • Clinical Standards (CDISC)
  • IT System Validation Overview

When delivering in-house training sessions for the Pharma Introduction course, the Drug Development History module is updated in collaboration with the client to reflect the specific company history, therapeutic areas and development specifics.

Learning Objectives
  • Knowledge of the pharmaceutical development processes, the regulatory framework, and IT systems used
  • Understand all aspects of the clinical development process, how the associated clinical systems support the processes and how the processes lead up to a new drug application
  • Understand how to collect and analyse clinical data, and report on clinical trials
Practicalities
  • LOCATION – We offer all training courses in-house at your location.
  • DURATION – 2 days
  • PRICING – EUR 1.270/DKK 9.450 + VAT per person – 10% discount with 10 or more participants.
  • ORDERING – Please contact us at training@herax.com
Pharma Business – IT Project Management

The complexity between the processes, the organizational change, and the IT systems used is increasing, creating a need for skilled project managers and participants.
This course provides a standard method with the tools, knowledge and processes needed to increase the effectiveness of internal projects for process optimization and IT implementations. The output of the course is knowledgeable Project Managers and employees who effectively contribute and manage projects covering process improvement and IT implementations.
Project participants will learn how to effectively plan projects, create business cases, plan and execute workshops, analyze processes, document planned changes in processes, organization and IT systems, and how to effectively plan, contribute to, manage and follow-up on project meetings.
Specific tools and templates for project management, business case development, and managing project activities will be provided, and real-life samples based on best practices will be used to teach how to apply them in projects.
Projects will run more smoothly and benefit from Project Managers and participants who are more focused and plan and use the project time more efficiently on the project activities and deliverables.
Participation in a HERAX Training Academy course requires dedication and focus due to a high paced training method. We wish to leave the participants with a significant amount of knowledge, so they can make a difference in the projects and daily work.

Content
  • Business Case Development
    • Identify issues, root causes, challenges and solutions
    • Benefit definition
    • Risk analysis
    • Impact analysis
  • Organizational Change Management
    • How to plan and implement the changes in the organization
    • Stakeholder Management
    • How to create project communication deliverables
  • How to create Use Cases and User Requirements Specifications
  • Project Activity Management
    • Basic project plan creation
    • Define deliverables and activities
    • How to effectively plan, contribute to, manage and follow-up on project meetings
    • How to structure your project time to “Get things done”
    • Learn how to write effective and structured project emails
    • How to create and track issues, dependencies and assumptions
    • How to effectively create documents, use version control and support multiple authors
  • Vendor Selection
    • Request for Information (RfI)
    • Request for Proposal (RfP) creation and management
    • Vendor rating and selection
  • IT System Validation
    • Introduction to test and validation of IT systems in pharma
    • Creation of validation plans
    • Creation of test cases and test plans
    • System change control management

Practicalities
  • LOCATION – We offer all training courses in-house at your location.
  • DURATION – 2 days
  • PRICING – EUR 1.270/DKK 9.450 + VAT per person – 10% discount with 10 or more participants.
  • ORDERING – Please contact us at training@herax.com