Regulatory Affairs: The Decentralised Procedure (DCP) (PRA23)
|Duration: 2 hours (the average time to complete the training program, including final assessments).
Credits Hours: 2
Accreditation: This training course offers CPD accreditation from the Faculty of Pharmaceutical Medicine of the Royal Colleges of Physicians.
CPD Credits: 2
Demonstration: Demo an online course.
Certificate: View sample certificate.
PRICE: USD $195.00
Training Program: Regulatory Affairs: The Decentralised Procedure (DCP)
Training Provided By: dinaris.org
Availability: Immediately available upon ordering.
Description: Online training with immediate access upon enrollment.
This course describes specific issues that apply to generic products in the Decentralized Procedure. It also discusses the requirements on timing, formats, and content of submissions, as well as the roles of the procedure’s various players. Also covered are the duration and sequence of the stages involved. Working to facilitate agreements among the participating states, the Coordination Group for Mutual Recognition and Decentralized Procedures additionally provides guidance.
The DCP is available to those wishing to gain multinational marketing authorization within the EEA (European Economic Area), and is one of three routes available. It can only be used for any product not already having a current marketing authorization in any member state. It is comparable to MRP (Mutual Recognition Procedure), but with earlier involvement of the Concerned Member States in the assessment by the Reference Member State.
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 of 80% or better.
Benefits of Getting Certified at dinaris.org
By employing advanced e-learning training techniques, and coupling them with new automated tracking systems, the dinaris.org provides professionally designed online courses which are effective at training, and assist those interested with advancing their careers. The dinaris.org also assists companies through maintaining training records, the education of their employees, and assisting them with improving their overall quality of service.
Should you have any particular question about this course, you can call us at (888) 111-1111 or send us an email at 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:
The Regulatory Affairs: The Decentralised Procedure (DCP) Course is Found in the Following Professional Certification Program(s):
Students completing this course should be able to:
JOB POSTINGS:313 Regulatory jobs found.
Displaying jobs #1-4.
Regulatory Reporting Specialist
Posted Date: 2017-06-23
COOK MEDICAL – United States, IN, Bloomington, 47404
Clinical Research Regulatory Affairs Manager
Posted Date: 2017-06-19
Medix – United States, WA, Seattle, 98127
Regulatory Compliance Analyst
Posted Date: 2017-06-19
Apex Life Sciences – United States, MD, Rockville, 20849
Associate Director Regulatory Affairs CMC
Posted Date: 2017-06-21
Ascent Life Sciences – United States, MA, Waltham, 02254
For more information on the dinaris.org’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) 111-1111, or email Support@BioPharmaInstitute.com.