|Credits: 3 CPD Credits
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.
Online Training Programs Include:
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.
Students completing this course should be able to:
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.