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Saturday, June 24, 2017
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Regulatory Affairs: The European Centralized Procedure (CP) (PRA20)

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: 1.5
Demonstration: Demo an online course.

Certificate: View sample certificate.

PRICE: USD $195.00

dinaris.org LogoTraining Program: Regulatory Affairs: The European Centralized Procedure (CP)
Training Provided By: dinaris.org
Website: http://dinaris.org

Availability: Immediately available upon ordering.

Description: Online training with immediate access upon enrollment.

This online course describes the procedure’s various players, the duration and sequence of the stages involved, and requirements on timing, format, and content of submissions. In the Centralized Procedure, one successful application results in the issuance of a license by the European Commission which applies throughout the Europe Economic Area. The Centralized Procedure is mandatory for specific kinds of products, and is one of three available routes to help applicants gain multinational marketing authorization within the EEA (European Economic Area).

This course includes a general introduction and detailed looks at procedure and guidance. Also covered are discussions of the following: marketing authorization, submissions, SAWP, CPA, European Medicines Agency, fast-track provisions, the appeals procedure, and more.

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 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 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: The European Centralized Procedure (CP) 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:


Introduction
This session provides background information. It specifies the types of product for which the CP is mandatory and those for which it is optional. It discusses the types of Marketing Authorisation Application, and characteristics of the application procedure.

Procedure
This session takes you through the entire process from pre-submission to what happens after an Opinion has been received.

Guidance
This session describes the advice process and provides details on how to receive SAWP advice.

COURSE OBJECTIVES:


Students completing this course should be able to:

–Provide an overview of the CP process.

–Identify which products may/must use the CP.

–For products for which the CP is optional, outline the advantages and disadvantages of the CP compared with other routes to marketing authorization.

–Describe requirements on content, format and timing of submissions.

–Describe how to get advice from the Scientific Advice Working Party (SAWP).

–Specify the sequence and duration of the stages of the CP and the responsibilities of the participants.

–Describe the role of the European Medicines Agency and its relevant competent committee.

–Outline fast-track provisions.

–Describe the appeals procedure.

JOB POSTINGS:

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

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

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

Study Start Up Regulatory Submissions Coordinator
Posted Date: 2017-06-23
Medpace – United States, OH, Cincinnati, 45208

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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