Student Login |


Friday, March 29, 2024
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

GCP: How to Obtain Approval to Conduct Clinical Trials in the EU Certification Training


Program/Course ID:GCP20
Enrollment Period:12 months.
Average Learning Time:~.
Additional Resources:Supplemental materials/activities.
Credit Hours:3 credits.
Method of Training:
Online, asynchronous, self-paced eLearning.
Accessibility:24/7 access to all program materials.
Demonstration:Four (4) free trial courses are available.
Group/Employee Training: Click here to request a quote.
Final Assessment:Multiple choice; unlimited attempts.
Certificate:Encrypted PDF with validation QR barcode.

2024 UPDATE:
This program is currently unavailable for enrollment.

It may have been updated or discontinued.
Check for newer version in our catalog.


.

Browse Our Catalog of 300+ Courses:

Catalog of Courses

Enroll into a Trial Course & Start Learning, Today:

Free Trial Courses

Outline:


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.

Objectives:


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.

Use our Search Form to Find What You're Looking For:

  

Benefits of Training with Biopharma Institute

Immediate access to courses:Username, password, instructions, and receipt of payment are immediately emailed upon online enrollment.
Self-paced, asynchronous eLearning:24/7 access to all course materials and assessments for 12 months.
Open enrollment:No prior course prerequisites or work experience required.
Expertise:Courses developed by subject matter experts (SMEs) in the area being taught.
Current and validated:Training is current with respect to regulations, procedures, and 3rd party validated and/or accredited.
Optimized for learning:Courses include voiceovers, easy navigation, reading materials, case studies, progress checks, and high-quality animations to increase retention of subject matter.
Secure and safe access:Encrypted website and LMS connections, firewall, and daily malware scans deliver optimal security and performance.
Flexible final assessments:Multiple-choice questions can be taken repeatedly until a passing score is achieved.
Direct access to certificates:Upon completion, certificates are immediately issued in an encrypted PDF format. Certificates include a watermark, unique validation code, and QR verification barcode.
Verification of training:Certificates are verifiable online using QR barcode or the unique ID code. Digital badges are additionally issued for all professional certification programs.
Training manager access:A proprietary portal offers access to download enrollment reports, training records, account balance, and more.
SCORM-compliant courses:Courses can be delivered directly to most corporate Learning Management Systems (LMS).
Purchase orders (POs):POs are accepted from all companies. Request an invoice when starting the procurement process.
Reimbursement:Some employers may reimburse their employees for training expenses. Check your company's policy.
Financial assistance:Payment plans are available to those who qualify. Alternatively, purchasing individual courses one at a time is also an option.
Career advancement:Professional certifications help demonstrate interest and dedication to career and job performance. They may be helpful for those seeking to grow their career or transitioning to a different position within an organization. Professional certifications are a great addition to a resume, offer talking points for the interview, and practical knowledge for performing duties.

Have Questions? Contact Us:


Use the form below if you would like more information on our programs. You may want to request a quote on group training or an invoice for generating a company purchase order. For quotes or invoices please provide the course(s) and number of students. Alternatively, call toll-free from the US or Canada: +1 (888) 424-6576. International callers may dial: +1 (201) 301-8370.

Name:
Company:
Phone:
Email:
 
Enter the number from the image above:
Comments:


For quotes or invoices please provide the course(s) and number of students.