HERAX Training Course Information

Pharma Introduction


DESCRIPTION

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. All the types of roles involved in developing a new drug and the necessary regulatory framework are 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.
Participation in a HERAX Training Academy course requires dedication and focus due to a high paced training method. We wish to impart the participants with a significant amount of knowledge so they can make a difference in the projects and daily work.

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)
• Clinical Development
• Investigational Medicinal Products

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• 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

LEARNING OBJECTIVES

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• 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

AUDIENCE

Pharmaceutical, healthcare, and IT professionals who require a broad perspective and deeper knowledge of the pharmaceutical industry, processes, standards, and IT systems.

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DURATION                                                                                                                                                  2 days course

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PRICE                                                                                                                                                  EUR 1.270/DKK 9.450 + VAT per person

DURATION

2 days course

PRICE

EUR 1.270/DKK 9.450 + VAT per person

IN-HOUSE COMPANY TRAINING

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

 
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DURATION                                                                                                                                                  2 days course

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PRICE                                                                                                                                                  EUR 1.270/DKK 9.450 + VAT per person

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DURATION                                                                                                                                                  2 days course

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PRICE                                                                                                                                                  EUR 1.270/DKK 9.450 + VAT per person

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DURATION                                                                                                                                                  1 day course

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PRICE                                                                                                                                                  EUR 470/DKK 3.490 + VAT per person

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DURATION                                                                                                                                                  1 day course

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PRICE                                                                                                                                                  EUR 470/DKK 3.490 + VAT per person

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DURATION                                                                                                                                                  1 day course

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PRICE                                                                                                                                                  EUR 470/DKK 3.490 + VAT per person

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DURATION                                                                                                                                                  1 day course

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PRICE                                                                                                                                                  EUR 470/DKK 3.490 + VAT per person

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DURATION                                                                                                                                                  1 day course

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PRICE                                                                                                                                                  EUR 470/DKK 3.490 + VAT per person

PRACTICALITIES


TERMS

Payment terms: Invoice will be sent after signing up.
The invoice must be paid no later than 14 days before training start.
For signup less than 14 days before training start, the invoice is due immediately.

CATERING

The training course includes morning refreshments and lunch. Water, coffee and tea are available throughout the day.
If requiring special dietary considerations please contact us at least 8 days in advance.

PARKING

Parking is free of charge.

WIFI

WIFI is free of charge.

TRAVEL AND ACCOMODATION

The nearest airport is Copenhagen Airport about 40 minutes away.
Please contact us for a list of hotels with discount rates for HERAX course participants.

 

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