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.
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?
Regulatory affairs and compliance staff, and all those who contribute to regulatory submissions, will find the module an invaluable introductory training course and/or a useful reference tool.
- Define the concept of variations to marketing authorizations in the EEA. - Identify which type of variation is appropriate for each kind of change to be made. - Identify the documentation required to support the variation. - Describe how to prepare and submit variation notifications or applications appropriate for each type of variation and route of regulatory approval, including options for grouping of variations and for work sharing of assessment.
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.