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Saturday, June 24, 2017
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Regulatory Affairs: EU Variations Procedure (PRA22)

Certification Training Duration: 2 hours (the average time to complete the training program, including final assessments).
Credits Hours: 2
CPD Accredited TrainingAccreditation: This training course offers CPD accreditation from the Faculty of Pharmaceutical Medicine of the Royal Colleges of Physicians.
CPD Credits: 3.5
Demonstration: Demo an online course.

Certificate: View sample certificate.

PRICE: USD $195.00

dinaris.org LogoTraining Program: Regulatory Affairs: EU Variations Procedure
Training Provided By: dinaris.org
Website: http://dinaris.org

Availability: Immediately available upon ordering.

Description: Online training with immediate access upon enrollment.

All variations to a marketing authorization’s terms must be approved by regulatory authorities. Within the European Economic Area, common approaches are adopted to variations to licenses approved through the Mutual, Decentralized, or Centralized Recognition Procedures. Each country applies its guidelines and legislation for national licenses. This online course details the classifications and legislation for variations and will teach the student to submit application variations for products authorized through one of the three multinational procedures available. The course also discusses the identification of required application types, the data required, the timelines, and the procedures to follow for a submission.

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 80% 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 dinaris.org

By employing advanced e-learning training techniques, and coupling them with new automated tracking systems, the dinaris.org provides professionally designed online courses which are effective at training, and assist those interested with advancing their careers. The dinaris.org also assists companies through maintaining training records, the education of their employees, and assisting them with improving their overall quality of service.

Have Questions?

Should you have any particular question about this course, you can call us at (888) 111-1111 or send us an email at for more information.


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:

  • Immediate access to training: Instructions, password, and username are emailed following order
  • 90 days of 24/7 access to individual training programs / 180 days for Professional Certification Program
  • Programs include voice-overs, easy navigation, progress checks, and high-quality animations
  • Course notes (in PDF) and/or references available with select training programs
  • Online final assessment with multiple-choice questions can be taken an unlimited number of times, until passing grade is achieved
  • A Certificate of Completion is immediately available once course requirements have been satisfied


The Regulatory Affairs: EU Variations Procedure Course is Found in the Following Professional Certification Program(s):


International 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

COURSE OUTLINE:


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 authorisations
This session describes the processes required to submit each of the three types of variations for products approved through the Centralised Procedure.

Applying for variations to MRP authorisations
This session describes the processes required to submit each of the three types of variations for products approved through the Mutual Recognition or Decentralised 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 module. Ideal for a refresher or consolidation of learning points.

COURSE OBJECTIVES:


Students completing this course should be able to:

–Define the concept of variations as applied to post-marketing 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.

JOB POSTINGS:

313 Regulatory jobs found.
Displaying jobs #1-4.

Regulatory Reporting Specialist
Posted Date: 2017-06-23
COOK MEDICAL – United States, IN, Bloomington, 47404

Clinical Research Regulatory Affairs Manager
Posted Date: 2017-06-19
Medix – United States, WA, Seattle, 98127

Regulatory Compliance Analyst
Posted Date: 2017-06-19
Apex Life Sciences – United States, MD, Rockville, 20849

Associate Director Regulatory Affairs CMC
Posted Date: 2017-06-21
Ascent Life Sciences – United States, MA, Waltham, 02254

See more Regulatory Jobs


For more information on the dinaris.org’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) 111-1111, or email Support@BioPharmaInstitute.com.

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