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Saturday, June 24, 2017
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Regulatory Affairs: The Decentralised Procedure (DCP) (PRA23)

Certification Training Duration: 2 hours (the average time to complete the training program, including final assessments).
Credits Hours: 2
CPD Accredited TrainingAccreditation: 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

dinaris.org LogoTraining Program: Regulatory Affairs: The Decentralised Procedure (DCP)
Training Provided By: dinaris.org
Website: http://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.

Have Questions?

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:

  • Immediate access to training: Instructions, password, and username are emailed following order
  • 90 days of 24/7 access to individual training programs / 180 days for Professional Certification Program
  • Programs include voice-overs, easy navigation, progress checks, and high-quality animations
  • Course notes (in PDF) and/or references available with select training programs
  • Online final assessment with multiple-choice questions can be taken an unlimited number of times, until passing grade is achieved
  • A Certificate of Completion is immediately available once course requirements have been satisfied


The Regulatory Affairs: The Decentralised Procedure (DCP) Course is Found in the Following Professional Certification Program(s):


International Regulatory Affairs Professional Certification Program: This professional certification program includes descriptions of the decentralized procedure (DCP), EU variations procedure, the mutual recognition procedure (MRP), the European centralized procedure (CP); requ … Learn more

COURSE OUTLINE:


Introduction
This session provides background information. It covers products for which the DCP can be used, the types of Marketing Authorisation Application, and characteristics of the application procedure.

DCP Step 1
This session takes you through the pre-procedural Step and the first assessment stage of the DCP, as far as day 120.

DCP Step 2
This session takes you through the second assessment stage and the final step of issuing national licences. Referral of issues to the CMD, and the arbitration process, are also covered.

Generics and the DCP
This session gives a brief introduction to generics and the special issues facing generics in the DCP.

COURSE OBJECTIVES:


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.

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

See more Regulatory Jobs


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.

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