Regulatory Affairs: EU Variations Procedure (PRA22)
|Duration: 2 hours (the average time to complete the training program, including final assessments).
Credits Hours: 2
Accreditation: 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
Training Program: Regulatory Affairs: EU Variations Procedure
Training Provided By: 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.
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:
The Regulatory Affairs: EU Variations Procedure Course is Found in the Following Professional Certification Program(s):
Students completing this course should be able to:
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
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.