|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.
Training Program: Pharmaceutical Regulatory Affairs: The Decentralized Procedure (DCP)
Training Provided By: BioPharma Institute
Availability: Immediately available upon ordering.
Description: Online training with immediate access upon enrollment. The DCP is one of three routes available to applicants to gain multinational marketing authorization within the European Economic Area (EEA). It can be used only for a product which has no existing marketing authorization in any member state. It is similar to The Mutual Recognition Procedure (MRP) but with earlier involvement of the Concerned Member States in the assessment by the Reference Member State. The Coordination Group for Mutual Recognition and Decentralized Procedures (CMD) provides guidance and acts to facilitate agreement among the participating states. This online course 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 DCP.
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 Pharmaceutical Regulatory Affairs: The Decentralized Procedure (DCP) course is found in the following professional certification program(s):
Students completing this course should be able to: Provide an overview of the DCP 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.