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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 (GCP020)

Certification Training
 
Rated 4.33/5
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Method of Training: Online / Self-paced eLearning.
Credits: 3 CPD Credits.
Duration: ~180 minutes.
Self-paced Training: 24/7 access to course.
Enrollment Period: 3 months.
CPD Accredited TrainingCatalog: Clinical Trials Management and Monitoring.
Demonstration: Try one of our FREE courses.
Certificate: View sample certificate.

PRICE: USD $175.00

Document a dedication to your career and job performance by earning a training certification from Biopharma Institute.

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 ordering.

Description: Online training with immediate access upon enrollment. 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 program and successfully pass an online, multiple-choice final assessment within a 90-day/3-month period (180 day/6-month period for Professional Certification Programs). Certificate of completion is accessible in PDF format immediately after satisfying requirements.

Biopharma Institute's online training programs include immediate access after enrollment. Username, password, and instructions are emailed to the student following enrollment into the program. Course takers can attempt the final assessment any number of times, as needed, to achieve a passing score. Once all training requirements have been satisfied a certification of training has been achieved and can be verified immediately from our website using a unique certification ID code. The certificate of completion is also instantaneously launched and made available to the student in a PDF format upon completion. Professional certification programs additionally include a digital badge to verify training, and can be displayed on social networking sites, such as LinkedIn.

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

COURSE 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.

COURSE 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
  • Summarise 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 authorisation 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 authorisation of a trial in progress
  • Identify changes that will be brought about by the Clinical Trials Regulation

Online Training: The Benefits of Remote Learning & eLearning

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  • Self-paced courses: 24/7 access to individual courses for 90 days, and for professional certification programs for 180 days.
  • Flexible final assessments: Assessment testing include multiple-choice questions and can be taken repeatedly until a passing score is achieved.
  • Direct access to certificates: Certificate of completion is instantly available once course requirements have been fulfilled.
  • Verification of training: Certificates can be verified online, and digital badges are issued for all Professional Certification programs.
  • Tuition reimbursement: Some employers may reimburse for training expenses; check on your company's training reimbursement policy.
  • Financial assistance: Payment plans are available to those who qualify. These are offered when paying electronic invoices, online. You must first request an invoice to be considered. Alternatively, purchasing individual courses one at a time is also an option.
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