Duration: 2 hours, Online (the average time to complete the training program, including final assessments).Credits Hours: 2
Self-paced Training: 24/7 access to course.
Enrollment Period: 3 months.
Demonstration: Try one of our FREE courses.
Certificate: View sample certificate.
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Contact the BioPharma Institute for more information.
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. A sponsor wishing to conduct clinical studies with an investigational drug in the European Union must seek and gain approval before each phase of clinical development. This entails submitting a Clinical Trial Authorization (CTA) application to the regulatory Competent Authority of each Member State (MS) in which the clinical trial is to be conducted. At the same time, the sponsor must apply for a favorable opinion from the relevant Ethics Committee(s) in each MS. Only when the authorization and favorable opinion have been obtained can the trial commence. This online course provides regulatory professionals with knowledge necessary to enable them to complete and submit applications for CTA and for Ethics Committee (EC) favorable opinion to conduct a clinical trial. It also provides information on what to do to maintain approval if the circumstances of the clinical trial change.
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.
Online Training Program Benefits:
- 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
- Corporate reimbursements: Employers may pay for or reimburse employees for training. Purchase orders (POs) for both individual and group training are accepted
- Corporate LMS solutions: 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 may 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.