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Regulatory Affairs: Variations to Marketing Authorizations in Europe (PRA22)

Certification Training
 
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Method of Training: Online / Self-paced eLearning.
Credits: 3.5 CPD Credits.
Duration: ~3.5 hour(s).
Self-paced Training: 24/7 access to course.
Enrollment Period: 3 months.
CPD Accredited TrainingCatalog: Pharmaceutical Regulatory Affairs.
Demonstration: Try one of our FREE courses.
Certificate: View sample certificate.

PRICE: USD $225.00

Document a dedication to your career and job performance by earning a training certification from Biopharma Institute.

Biopharma Institute LogoTraining Program: Regulatory Affairs: Variations to Marketing Authorizations in Europe
Training Provided By: Biopharma Institute
Website: https://www.biopharmainstitute.com

Schedule: Self-paced. Immediate access to training materials upon ordering.

Description: Online training with immediate access upon enrollment. Biopharma Institute Reviews

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, students will immediately receive a certificate of completion (PDF) and have been introduced to appropriate guidelines and pharmaceutical industry standards. This program assures that the student will understand the federal regulation compliances and how to conduct work which adheres to these standards.

This online training program includes immediate access after enrollment. Username, password, and instructions are emailed to the student following the enrollment into the program. 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 certification of training has been achieved and a certificate is immediately made available to the student.

Benefits of Getting Certified at Biopharma Institute

Throughout many of our courses, students will engage in active learning using interactive eLearning modules developed to promote the learning of key knowledge and information. For companies seeking a method to train employees, economically, without having to set aside an entire day for them to attend a live course, Biopharma Institute is the training partner you can rely on. Our training provides an effective, engaging, interactive, self-paced learning experience which fits in with most types of learners. We cater to both small-scale and large-scale training requests, customizing your employee's education.


Certification Requirements: Students must view the entire program and successfully pass an online, multiple-choice final assessment with passing score within a 90-day period of time (180 days for Professional Certification Programs). Certificate is accessible in PDF format immediately after satisfying requirements.


COURSE OUTLINE:


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.

COURSE OBJECTIVES:


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.

Objectives
- 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.

The Regulatory Affairs: Variations to Marketing Authorizations in Europe Course is Included in the Following Professional Certification Programs:


International Pharmaceutical Regulatory Affairs Professional Certification Program: This professional certification program includes descriptions of the decentralized procedure (DCP), EU variations procedure, the mutual recognition procedure (MRP), the European centralized procedure (CP); requ ... Learn more

Online Training: The Benefits of eLearning

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  • Self-paced courses: 24/7 access to individual courses for 90 days, and for professional certification programs for 180 days.
  • Flexible final assessments: Assessment testing include multiple-choice questions and can be taken repeatedly until a passing score is achieved.
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