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Sunday, December 16, 2018
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Regulatory Affairs: The Mutual Recognition Procedure (MRP) (PRA21)

Certification Training CPD Accredited TrainingCredits: 2 CPD Credits
Self-paced Training: 24/7 access to course.
Enrollment Period: 3 months.
Catalog: Pharmaceutical Regulatory Affairs.
Demonstration: Try one of our FREE courses.
Certificate: View sample certificate.

PRICE: USD $145.00

BioPharma Institute LogoTraining Program: Regulatory Affairs: The Mutual Recognition Procedure (MRP)
Training Provided By: BioPharma Institute
Website: https://www.biopharmainstitute.com

Availability: Immediately available upon ordering.

Description: Online training with immediate access upon enrollment.

The Mutual Recognition Procedure is one of three routes available to applicants to gain multinational Marketing Authorization within the European Economic Area (EEA) on the basis of a single application. A national authorization is converted to harmonized authorizations issued in a number of other member states chosen by the applicant.

The MRP is similar to the Decentralized Procedure but with later involvement of the Concerned Member States in the assessment by the Reference Member State. The Coordination Group for Mutual Recognition and Decentralized Procedures provides guidance and acts to facilitate agreement among the participating states.

This module describes the roles of the various players in the procedure, the sequence and duration of the stages involved, and the requirements on content, format and timing of submissions. It discusses the special issues that apply to generic products in the MRP.

Once all course requirements have been satisfied, a certificate of completion is immediately available. Course takers can attempt the final assessment any number of times, as needed, in order to achieve a passing grade.

Benefits of Getting Certified at BioPharma Institute

By employing advanced e-learning training techniques, and coupling them with new automated tracking systems, the BioPharma Institute provides professionally designed online courses which are effective at training, and assist those interested with advancing their careers. The BioPharma Institute 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) 424-6576 or send us an email at support@biopharmainstitute.com 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, 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 Regulatory Affairs: The Mutual Recognition Procedure (MRP) course is found in the following professional certification program(s):


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


COURSE OUTLINE:


Course overview – Provides an overview of the content of the module and outlines related courses.

Introduction – This session provides background information. It covers products for which the MRP can be used, the types of Marketing Authorization Application, and characteristics of the application procedure.

The MRP process – This session takes you through the entire process from initial national authorization by the RMS to the issuing of national licences by the CMSs. Referral of issues to the CMD, and the arbitration process, are also covered.

Generics and the MRP – This session gives a brief introduction to generics and the special issues that apply to generic products in the MRP.

Assessment – Multiple-choice mastery assessment.

COURSE OBJECTIVES:


Who will benefit from this module?

This module is primarily aimed at regulatory affairs professionals dealing with marketing authorization applications and related submissions for regulatory approval in Europe. More generally, it will also be of interest to all those involved in the development and registration of medicinal products.

Objectives

-Provide an overview of the MRP process.
-Describe the pre-submission and submission actions in relation to timeline deadlines.
-Specify the responsibilities of the Reference Member State (RMS), the Concerned Member States (CMSs) and the applicant.


For more information on the BioPharma Institute’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) 301-8370, or email Support@BioPharmaInstitute.com.

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