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

GCP: 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: ~3 hour(s).
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.

Biopharma Institute LogoTraining Program: GCP: 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.

This online training program includes immediate access after enrollment. Username, password, and instructions are emailed to the student following the enrollment into the program. Course takers can attempt the final assessment any number of times, as needed, in order to achieve a passing grade. Once all course requirements have been satisfied, a certification of training has been achieved and a certificate is immediately made available to the student.

Benefits of Getting Certified at Biopharma Institute

Throughout many of our courses, students will engage in active learning using interactive eLearning modules developed to promote the learning of key knowledge and information. For companies seeking a method to train employees, economically, without having to set aside an entire day for them to attend a live course, Biopharma Institute is the training partner you can rely on. Our training provides an effective, engaging, interactive, self-paced learning experience which fits in with most types of learners. We cater to both small-scale and large-scale training requests, customizing your employee's education.


Certification Requirements: Students must view the entire program and successfully pass an online, multiple-choice final assessment with passing score within a 90-day period of time (180 days for Professional Certification Programs). Certificate is accessible in PDF format immediately after satisfying requirements.


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

The GCP: How to Obtain Approval to Conduct Clinical Trials in the EU Course is Included in the Following Professional Certification Programs:


Clinical Trials Management (US & EU) Professional Certification Program: This online professional certification program is for regulatory affairs personnel, clinical managers, project managers, investigators, and clinical research associates. It is also available to those interested ... Learn more

Obtaining Approval for Clinical Trials in US & EU Professional Certification Program: This professional certification program is designed for regulatory affairs managers and directors, project managers, or clinical research associates and coordinators with desire to grow their career into these ... Learn more

Online Training: The Benefits of eLearning

  • Immediate access to training: Instructions, username, password, and receipt of payment are emailed instantly upon online enrollment.
  • Optimized for learning: Courses include voice-overs, easy navigation, progress checks, and high-quality animations to increase retention of subject matter.
  • 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 requirements.
  • 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.
  • Purchase orders (POs) accepted: If a PO is required by your company, request an invoice to start the procurement process.
  • Corporate LMS compatibility: All courses are SCORM compliant and can be delivered from most corporate Learning Management Systems.
  • Secure and safe access: Website and LMS provide an encrypted connection with firewall protection and daily scans for optimal level of security and performance.
  • Career advancement: Professional certifications help demonstrate your interest and dedication to job performance, and may be helpful for those seeking a new career or transitioning to different positions within their organization.

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