Duration: 2 hours, Online (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.
The Pharmaceutical Regulatory Affairs: EU Variations Procedure course is found in the following professional certification program(s):
Defining variations: This session identifies and describes the three main types of EU variations.
Determining variation types: This session looks at the reasons for variations and the applicable EU regulations.
General procedural aspects: This session looks at the documentation that has to be submitted with variation applications and also describes an urgent safety restriction.
Applying for variations to CP authorizations: This session describes the processes required to submit each of the three types of variations for products approved through the Centralized Procedure.
Applying for variations to MRP authorizations: This session describes the processes required to submit each of the three types of variations for products approved through the Mutual Recognition or Decentralized Procedure, including the role of the EudraTrack system.
Case study: This part consists of a case study requiring the learner to determine the correct variation submission route and data requirements and also understand the consequences of making mistakes during the submission process.
Key point summary: Key point summary for all topics covered in The course. Ideal for a refresher or consolidation of learning points.
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.
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.