|Credits: 3.5 CPD Credits
Self-paced Training: 24/7 access to course.
Enrollment Period: 3 months.
Catalog: Pharmaceutical Regulatory Affairs.
Demonstration: Try one of our FREE courses.
Certificate: View sample certificate.
PRICE: USD $195.00
Training Program: Regulatory Affairs: Variations to Marketing Authorizations in Europe
Training Provided By: BioPharma Institute
Availability: Immediately available upon ordering.
Description: Online training with immediate access upon enrollment.
Changes to the terms of marketing authorizations for medicinal products, called variations in Europe, must be notified to or approved by the relevant regulatory authorities. Variations include changes to the composition of products, their manufacturing processes, the way they are used, or the indications for which they are authorized. Common approaches are adopted within the European Economic Area to variations to marketing authorizations approved through the Centralized, Decentralized or Mutual Recognition Procedures. Recent legislation has substantially modified the regulatory requirements and extended them to purely national authorizations by member states. This module, which is fully up to date with the new legislation, covers the classification of variations into their several types and the regulatory requirements, guidance and procedures to be followed for each type.
This course includes case studies, applying for variations to MRP authorizations, applying for variations to CP authorizations, general procedural aspects, EU regulations, defining variations, and ends with a key point summary.
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 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.
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 Regulatory Affairs: Variations to Marketing Authorizations in Europe course is found in the following professional certification program(s):
Defining variations – This session identifies and characterizes the different types of variation.
Determining variation types – This session looks at the reasons for variations and describes how to identify the type of variation appropriate for each change required.
General procedural aspects – This session describes the different routes to regulatory approval of variations, identifies which is appropriate for a given product, specifies the supporting documentation necessary, and describes the provisions for grouping multiple variations into a single submission and for work sharing of regulatory assessment among member states.
Variations via the Centralized Procedure – This session describes the processes specific to the submission and processing of variations notifications and applications through the Centralized Procedure.
Variations via the Mutual Recognition Procedure – This session describes the processes specific to the submission and processing of variations notifications and applications through the Mutual Recognition Procedure.
Case study – A case study of a flawed submission process.
Assessment – Multiple-choice mastery assessment.
Who will benefit from this module?
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.