|Credits: 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
Training Program: Regulatory Affairs: The Mutual Recognition Procedure (MRP)
Training Provided By: BioPharma Institute
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.
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.
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: The Mutual Recognition Procedure (MRP) course is found in the following professional certification program(s):
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.
Who will benefit from this module?
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.