|Duration: 2 hours (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.
THIS COURSE IS CURRENTLY NOT AVAILABLE.
Contact the BioPharma Institute for more information.
Training Program: Pharmaceutical Regulatory Affairs: EU Variations Procedure
Training Provided By: BioPharma Institute
Availability: Immediately available upon ordering.
Description: Online training with immediate access upon enrollment. Regulatory authorities must approve any variation to the terms of a marketing authorization. Common approaches are adopted within the European Economic Area to variations to licenses approved through the Centralized, Decentralized or Mutual Recognition Procedures. For national licenses, each country applies its legislation and guidelines. This online course details the legislation and classifications for variations and will enable the learner to submit variations applications for products authorized through any of the three multinational procedures. It describes how to identify the type of application required, the procedures to follow, the timelines, and the data required for a submission.
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 Pharmaceutical Regulatory Affairs: EU Variations Procedure course is found in the following professional certification program(s):
Students completing this course should be able to: Define the concept of variations as applied to postmarketing regulatory activity in the EU. Identify which type of variation is appropriate for the change being proposed. Identify the data required to support the variation being made. Describe how to prepare and submit variation applications for products authorized through the EU Centralized, Decentralized or Mutual Recognition Procedures.
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.