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Saturday, January 19, 2019
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Pharmaceutical Regulatory Affairs: The European Centralized Procedure (CP) (PRA020)

Certification Training Duration: 2 hours (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.

BioPharma Institute LogoTraining Program: Pharmaceutical Regulatory Affairs: The European Centralized Procedure (CP)
Training Provided By: BioPharma Institute
Website: https://www.biopharmainstitute.com

Availability: Immediately available upon ordering.

Description: Online training with immediate access upon enrollment. The CP is one of three routes available to applicants to gain multinational marketing authorization within the European Economic Area (EEA). In the CP, one successful application leads to a license being issued by the European Commission that applies throughout the EEA. The CP is mandatory for certain types of products. This online course describes the various players in the procedure, the sequence and duration of the stages involved, and the requirements on content, format and timing of submissions.
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, user name, 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 training: 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
  • 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
  • Career advancement: Professional certifications may be helpful for those seeking new careers or transitioning to different positions within their organization


The Pharmaceutical Regulatory Affairs: The European Centralized Procedure (CP) course is found in the following professional certification program(s):


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 Authorization 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.


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