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Home » Clinical Trials: How to Obtain Approval to Conduct Clinical Trials in the EU

Clinical Trials: How to Obtain Approval to Conduct Clinical Trials in the EU

Certification Training
 
Rated 4.13/5
16 reviews
Program/Course ID: GCP020
Enrollment Period: 6 months.
Average Learning Time: ~180 minutes.
Additional Resources: Supplemental materials/activities.
Accredited Program: 3 CPD Credits.
Method of Training: Online / Self-paced eLearning.
Accessibility: 24/7 access to all program materials.
CPD Accredited TrainingCatalog: Clinical Trials Management and Monitoring.
Demonstration: Five (5) free trial courses are available.
Final Assessment: Multiple choice; unlimited attempts.
Certificate: PDF with validation code (See sample).
  Price: $175.00 USD  

Document your dedication to quality, compliance, safety, and job performance by earning a training certification.

Training Program: Clinical Trials: How to Obtain Approval to Conduct Clinical Trials in the EU
Training Provided By: Biopharma Institute
Website: https://www.biopharmainstitute.com

Schedule: Self-paced. Immediate access to training materials upon enrollment.

Description:
Biopharma Institute Reviews

To conduct a clinical trial in the European Economic Area the sponsor must apply for authorization from the national competent authority (i.e. medicines regulator), and favorable opinion must be obtained from a research ethics committee, in each member state in which the trial is to take place. This module sets out the requirements for successful compilation, submission and maintenance of the applications.

In addition to being fully compliant with current European Union legislation, the module looks forward to the implementation of the Clinical Trials Regulation.

Certification Requirements: Students must view the entire course and successfully pass an online, multiple-choice final assessment within a 6-month period, or a 12-month period for professional certification programs. A certificate of completion is immediately accessible in PDF format after satisfying the requirements.

Biopharma Institute certificates and digital badges include the date of completion, but do not have an expiration date. However, compliance training is typically considered valid for a period of 3 years. Many organizations suggest that compliance training should be refreshed at least every three years to stay up to date with regulations, standards, guidelines, and to reinforce the importance of maintaining compliance. The validity period for employee compliance training would be determined by those responsible for managing quality assurance.

Biopharma Institute's online training courses include immediate access after enrollment. Username, password, and instructions are emailed to the student directly following online enrollment into the program. Course takers may attempt the final assessment any number of times, as needed, to achieve a passing score. The certificate of completion is instantaneously launched and made available to the student in a PDF format upon completion.

Once all training requirements have been satisfied the achievement can be verified from our website using the unique ID code found on the certificate. Professional certification programs issue a digital badge to verify training and document the achievement. These digital badges can be displayed on social networking sites, such as LinkedIn, Facebook, Twitter, and Badgr.


Outline:


Overview
An outline of the module's scope and objectives, and notes on terminology.

The European context
This session explains the legal and regulatory framework for clinical trials in Europe.

Applying for approval
This session outlines the application procedures for clinical trial authorization (CTA) and for ethics committee (EC) favorable opinion. It provides a decision tree through which you can determine whether your prospective investigation is a clinical trial. It describes how to register a trial with the EudraCT database and obtain a EudraCT number. It summarizes the contents of applications and the processes and outcomes of reviews.

Application for clinical trial authorization
The contents of a CTA application are discussed in more detail, focusing on the investigator's brochure, investigational medicinal product (IMP) dossier, circumstances in which a simplified IMPD or Summary of Product Characteristics may be substituted, and other IMP-related data. Online compilation of the application form is explained.

Application for ethics committee favorable opinion
Significant features of an application for EC favorable opinion are discussed in more detail, including the clinical protocol, informed consent form, and subject recruitment materials.

Maintaining authorization
This session deals with the regulatory compliance activities that have to be carried out once a clinical trial has been approved. It examines the procedure for submitting substantial amendments, safety reporting requirements, and declaration of the end of a trial.

The Clinical Trials Regulation
This short session looks forward to the introduction of the Clinical Trials Regulation, which will replace the Clinical Trials Directive and establish greater uniformity in procedures for approval of clinical trials throughout the EEA.

Assessment
Multiple-choice mastery assessment.

Objectives:


Who will benefit from this module?
  • Regulatory affairs professionals and other staff of pharmaceutical or biotechnology companies involved in clinical development of medicinal products; and
  • healthcare professionals conducting clinical research as sponsor-investigators.

It will be of particular value to those who are new to European regulatory affairs, but familiarity with the basics of Good Clinical Practice is assumed.

Learning objectives
  • Outline the legal and regulatory framework that governs clinical trials in the European Economic Area
  • Summarize the procedures that must be carried out to gain approval to proceed with a trial
  • Identify the principal components of an application to a national competent authority for clinical trial authorization and describe their contents
  • Discuss the principal areas of concern to an ethics committee and describe the information to be submitted to one
  • Specify what measures must be taken to maintain the authorization of a trial in progress
  • Identify changes that will be brought about by the Clinical Trials Regulation

Clinical Trials: How to Obtain Approval to Conduct Clinical Trials in the EU is included in the following professional certification programs:



Professional Certification Program:

Clinical Trials Management (US & EU) Professional Certification Program

Course ID: GCP00A1
Price: $1295.00 (USD) | Learn more

Training Program For Professionals:

Obtaining Approval for Clinical Trials in US & EU for Regulatory Professionals

Course ID: GCP00A2
Price: $895.00 (USD) | Learn more

Benefits of Being Certified from Biopharma Institute: Throughout many of our online training programs students will be engaging in active learning through the use of interactive eLearning modules validated by 3rd party organizations for relavancy and regulatory content. The courses are developed by subject matter experts (SMEs) to promote the retaining of key knowledge. They offer access to regulatory references, real-life case studies, and introduce other important information necessary to assist with learning. Since 2003, Biopharma Institute has been aiding both professionals and their corporate employers with fulfilling training requirements. Biopharma Institute's certifications are recognized by a wide spectrum of industries, regulators, and companies around the world. Furthermore, our training solutions are customizable to any organization's training needs. Today, Biopharma Institute offers over 200 courses training on clinical research, drug manufacturing (cGMP), regulatory affairs, validation systems, pharmacovigilance, good laboratory practice (GLP), and data integrity for the clinical research, pharmaceutical, and medical device industries.

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Benefits of Training with Biopharma Institute

  • Immediate access to training: Instructions, username, password, and receipt of payment are emailed instantly upon online enrollment.
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  • Optimized for learning: Courses include voice-overs, easy navigation, case studies, progress checks, and high-quality animations to increase retention of subject matter.
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  • Flexible final assessments: Assessment testing include multiple-choice questions and can be taken repeatedly until a passing score is achieved.
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