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 European Centralized Procedure (CP)
Training Provided By: BioPharma Institute
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 75% 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 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.
The Regulatory Affairs: The European Centralized Procedure (CP) course is found in the following professional certification program(s):
Module overview - Provides an overview of the content of the module and outlines related courses.
An introduction to the Centralized Procedure - 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.
The Centralized Procedure process - This session takes you through the entire process from pre-submission to what happens after an Opinion has been received.
Assessment - Multiple-choice mastery assessment.
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.
-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. -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.
Online Training Program Benefits:
- Immediate access to training: Instructions, username, 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 courses: 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
- Verification of training: Certificates can be verified online, and electronic badges are issued for all Professional Certification programs
- 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
- Secure and safe access: Website and LMS offer an encrypted connection with firewall protection and daily scans for optimal level of security and performance
- Career advancement: Professional certifications may be helpful for those seeking new careers or transitioning to different positions within their organization
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.