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Tuesday, November 30, 2021
Home » Regulatory Affairs: The Mutual Recognition Procedure (MRP)

Regulatory Affairs: The Mutual Recognition Procedure (MRP)

Certification Training
 
Rated 4.18/5
17 reviews
Program/Course ID: PRA21
Enrollment Period: 6 months.
Average Learning Time: ~120 minutes.
Additional Resources: Supplemental materials/activities.
Accredited Program: 2 CPD Credits.
Method of Training: Online / Self-paced eLearning.
Accessibility: 24/7 access to all program materials.
CPD Accredited TrainingCatalog: Pharmaceutical Regulatory Affairs.
Demonstration: Five (5) free trial courses are available.
Final Assessment: Multiple choice; unlimited attempts.
Certificate: PDF with validation code (See sample).
  Price: $195.00 USD  

Document your dedication to compliance, safety, and job performance by earning a training certification from Biopharma Institute

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

Schedule: Self-paced. Immediate access to training materials upon ordering.

Description: Online training with immediate access upon enrollment. Biopharma Institute Reviews

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.

Certification Requirements: Students must view the entire program and successfully pass an online, multiple-choice final assessment within a 90-day/3-month period (180 day/6-month period for Professional Certification Programs). Certificate of completion is accessible in PDF format immediately after satisfying requirements.

Biopharma Institute's online training programs include immediate access after enrollment. Username, password, and instructions are emailed to the student following enrollment into the program. Course takers can attempt the final assessment any number of times, as needed, to achieve a passing score. Once all training requirements have been satisfied a certification of training has been achieved and can be verified immediately from our website using a unique certification ID code. The certificate of completion is also instantaneously launched and made available to the student in a PDF format upon completion. Professional certification programs additionally include a digital badge to verify training, and can be displayed on social networking sites, such as LinkedIn.


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.

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.

Regulatory Affairs: The Mutual Recognition Procedure (MRP) is included in the following professional certification programs:



Professional Certification Program:

International Pharmaceutical Regulatory Affairs Professional Certification Program

Course ID: PRA00A1
Price: $1795.00 (USD) | Learn more

Benefits of Being Certified from Biopharma Institute: Throughout many of our online training programs students will be engaging in active learning through the use of interactive eLearning modules which have been developed to promote the retaining of key knowledge, access to references, case studies, and other important information necessary to assist with learning. Since 2003, Biopharma Institute has been aiding both professionals and corporations with their training requirements. Biopharma Institute certifications are recognized by a wide spectrum of industries and companies, and our training solutions are customizable to any organization's training needs. Today, Biopharma Institute offers over 200 courses training on clinical research, drug manufacturing, regulatory affairs, validation systems, pharmacovigilance, good clinical laboratory practice (GCLP), data integrity, and medical devices.

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Online Training: The Benefits of Remote Learning & eLearning

  • Immediate access to training: Instructions, username, password, and receipt of payment are 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 courses: 24/7 access to individual courses for 90 days, and for professional certification programs for 180 days.
  • Flexible final assessments: Assessment testing include multiple-choice questions and can be taken repeatedly until a passing score is achieved.
  • Direct access to certificates: Certificate of completion is instantly available once course requirements have been fulfilled.
  • Verification of training: Certificates can be verified online, and digital badges are issued for all Professional Certification programs.
  • Tuition reimbursement: Some employers may reimburse for training expenses; check on your company's training reimbursement policy.
  • Financial assistance: Payment plans are available to those who qualify. These are offered when paying electronic invoices, online. You must first request an invoice to be considered. Alternatively, purchasing individual courses one at a time is also an option.
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  • Corporate LMS compatibility: All courses are SCORM compliant and can be delivered from most corporate Learning Management Systems.
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