Length of Course: Approximate time to complete this course is 3 hour(s).
Self-paced Training: 24/7 access to course.
Enrollment Period: 3 months.
Catalog: Clinical Trials Management and Monitoring.
Demonstration: Try one of our FREE courses.
Certificate: View sample certificate.
PRICE: USD $145.00
Training Program: GCP: How to Obtain Approval to Conduct Clinical Trials in the EU
Training Provided By: BioPharma Institute
Availability: Immediately available upon ordering.
Description: Online training with immediate access upon enrollment.
Before each phase of clinical development, approval must be sought and gained for any sponsor desiring to conduct investigational drug clinical studies in the European Union. This online course enlightens regulatory professionals with the knowledge needed to help them put together and present applications for EC (Ethics Committee) and CTA favorable opinion. Additionally, it supplies information on how to maintain approval even if the clinical trial circumstances change. Only after the favorable opinion and authorization have been obtained is it proper for trials to commence. A sponsor must apply in each Member State (MS) for the relevant Ethics Committee's favorable opinion. This entails the submission of a CTA (Clinical Trial Authorization) Application to the Member State's regulatory Competent Authority pertinent to the area/state in which the clinical trial is to be commenced.
The entire program must be viewed by students in order to pass. An online, multiple-choice final assessment score of 75% or better is required. 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 Certificate of Completion is immediately available.
Benefits of Getting Certified at BioPharma Institute
By employing advanced e-learning training techniques, and coupling them with new automated tracking systems, the BioPharma Institute provides professionally designed online courses which are effective at training, and assist those interested with advancing their careers. The BioPharma Institute also assists companies through maintaining training records, the education of their employees, and assisting them with improving their overall quality of service. Because the BioPharma Institute understands how often things change in the clinical research, pharmaceutical, and healthcare industries, we know how important it is that you, your employees, and your colleagues be updated on as many of these changes as is possible in order to stay current and relevant in the industry. For this very reason, we have, for over two decades, provided various learning tools and online courses to help individuals and/or companies stay on top of the latest changes and satisfy their educational needs.
Certification Requirements: Students must view the entire program and successfully pass an online, multiple-choice final assessment with >80% passing grade within a 90 day period of time (180 days for Professional Certification Programs). Certificate is accessible in PDF format immediately after satisfying requirements.
The GCP: How to Obtain Approval to Conduct Clinical Trials in the EU course is found in the following professional certification program(s):
Overview: The requirements for CTA and EC favorable opinion are introduced, and the scope and learning objectives of The course are specified.
The European context: The EU regulatory environment is described, the Clinical Trials Directive is introduced, and the requirements on clinical trials are summarized.
Applying for approval: The required contents of the two submissions are summarized, and the main steps in the application processes are set out.
The CTA application: The main elements of the CTA application are described, particularly the Investigator's Brochure and the Investigational Medicinal Product Dossier, and the data required are discussed. The timelines of the application process are specified.
The EC application: The key components of the EC application are described, particularly the clinical protocol and documents relating to patient recruitment and informed consent. The timelines of the application process are specified.
Maintaining a CTA: The procedures necessary to maintain authorization are described, particularly the submission of amendments and the reporting of adverse reactions.
Summary: Key point summary of topics covered in The course. Ideal for review, a refresher, or consolidation of learning.
Students completing this course should be able to:
--Explain what a Clinical Trial Authorization (CTA) application is, why it is required, and to which bodies it should be submitted.
--Explain what an application for an Ethics Committee (EC) Opinion is, why it is required and to which bodies it should be submitted.
--Describe the regulatory environment governing CTA applications and access the key regulatory documents.
--Summarize the information that should be included in the CTA and EC applications.
All Courses in the Clinical Trials Management and Monitoring Catalog:
|GCP: ICH Good Clinical Practice (ICH-GCP): Many regulatory changes are happening in the pharmaceutical industry. Those who are particularly affected are individuals involved in research. When carrying out research duties, there is always the risk of bre ... Learn more|
|GCP: Clinical Trial Preparation and Design: Worldwide expenditure by pharmaceutical companies on research and development is continually increasing. In the production of a new drug, most of the financial investment is allocated to clinical trials. It is ... Learn more|
|GCP: Clinical Trials and Drug Development: This online course teaches the students about how clinical trials fit into the process of drug development. Key historical events which have led to the development of controlled clinical trials is outlined. The ... Learn more|
|GCP: Clinical Trial Monitoring: Site Evaluation and Set-up: Site evaluation and the set-up's purpose is to ensure that the site is fully prepared for the conduct of the clinical trial, facilitates to conduct the study, has adequate time and appropriately qualified staff ... Learn more|
|GCP: Clinical Trial Monitoring - Documentation and Closure: Once the initiation of a trial begins, the CRA (clinical research associate) has a crucial role which is to monitor the conduct of the trial, as well as the recorded data's integrity. This online course will fa ... Learn more|
|GCP: Preparing for an Audit or Inspection: In order to ensure compliance with GCP (Good Clinical Practice), clinical trial sites of investigators and sponsors are subject to rigorous inspection by regulatory agencies. In this course, United States and E ... Learn more|
|GCP: Application Process to Conduct FDA-regulated Clinical Trials in USA: The IND (Investigational New Drug) Application is a submission through which the sponsor seeks approval from the FDA (Food And Drug Administration) to conduct clinical studies with an investigational drug. This ... Learn more|
|GCP: How to Obtain Approval to Conduct Clinical Trials in the EU: Before each phase of clinical development, approval must be sought and gained for any sponsor desiring to conduct investigational drug clinical studies in the European Union. This online course enlightens regul ... Learn more|
Online Training: The Benefits of eLearning
- Immediate access to training: Instructions, username, password and receipt of payment 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 180 days for professional certification programs
- Flexible final assessments: Tests include multiple-choice questions and can be taken repeatedly until a passing score is achieved
- Direct access to certificates: Documentation instantly available once course requirements have been fulfilled
- Verification of training: Certificates can be verified online, and electronic badges are issued for all Professional Certification programs
- Tuition reimbursement: Some employers may reimburse for training expenses; check on your company's requirements
- Purchase orders (POs) accepted: If POs are required, 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 offer an encrypted connection with firewall protection and daily scans for optimal level of security and performance
- Career advancement: Professional certifications could be helpful for those seeking new careers or transitioning to different positions within their organization
For more information on the BioPharma Institute's training programs, or to suggest a course, please complete the form located below. Alternatively, you may call toll free in the US: (888) 4-BIO-LRN, international callers can dial (201) 301-8370, or email Support@BioPharmaInstitute.com.