Length of Course: Approximate time to complete this course is 2 hour(s).
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 Decentralised 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) on the basis of a single application. 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 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 DCP.
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 75% or better.
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 Decentralised Procedure (DCP) 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 Decentralized Procedure - This session provides background information. It covers products for which the DCP can be used, the types of Marketing Authorization 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.
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.
Objectives - 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.
All Courses in the Pharmaceutical Regulatory Affairs Catalog:
|Regulatory Affairs: Essentials for Human Medicinal Products - EU and US: This foundation-level training program is the ideal introduction for entrants new to the field of pharmaceutical compliance and regulatory affairs. It describes the principal requirements needed in order to mai ... Learn more|
|Regulatory Affairs: Orphan Drug Application - EU and US: Medicines for the prevention, diagnosis, or treatment of rare diseases have become known as 'orphan drugs' because they are commercially unattractive. Development of such products is successfully encouraged thr ... Learn more|
|Regulatory Affairs: Preparing Submissions in the Common Technical Document (CTD) Format: The CTD is the internationally recognized standard format for submissions to medicines regulatory authorities. Its use is mandatory for all applications in the European Economic Area, required for prescription ... Learn more|
|Regulatory Affairs: Electronic Common Technical Document (eCTD): The eCTD specification has been developed to facilitate the global electronic submission, review and lifecycle management of medicinal product dossiers for regulatory applications. It broadens the scope of the ... Learn more|
|Regulatory Affairs: How to Gain Approval to Market Generic Drugs in the US: This course outlines the legislative and regulatory context for the development of generic drugs and describes the essential role of the Abbreviated New Drug Application (ANDA) in gaining marketing approval. Th ... Learn more|
|Regulatory Affairs: Submitting a New Drug Application (NDA) to Obtain Approval to Market in the US: An NDA (New Drug Application) is a regulatory vehicle through which sponsors formally propose that the FDA approve a new drug for marketing and sale in the USA. For successful approval, what format and content ... Learn more|
|Regulatory Affairs: The European Centralized Procedure (CP): 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 ... Learn more|
|Regulatory Affairs: The Mutual Recognition Procedure (MRP): 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 nati ... Learn more|
|Regulatory Affairs: Variations to Marketing Authorizations in Europe: Changes to the terms of marketing authorizations for medicinal products, called variations in Europe, must be notified to or approved by the relevant regulatory authorities. Variations include changes to the co ... Learn more|
|Regulatory Affairs: The Decentralised Procedure (DCP): The DCP 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. It can be used only for a produ ... Learn more|
|Regulatory Affairs: Registration of Drugs Based on Monoclonal Antibodies: This course addresses characteristic issues influencing the registration of medicinal products based on monoclonal antibodies (mAbs), for use in humans. Regulatory requirements for the registration of biologica ... Learn more|
|Regulatory Affairs: The Regulatory Pathway to Licensing Follow-on Biologics (Biosimilars) in the USA: The regulation of biological medicinal products is governed by different laws from those that apply to small-molecule synthetic drugs. Producing faithful copies of therapeutic proteins is more challenging than ... Learn more|
|Regulatory Affairs: Essentials of Monoclonal Antibodies: Monoclonal antibodies (mAbs for short) are the leading products of biotechnology. Drugs based on mAbs dominate the list of top-selling medicines worldwide. In addition, mAbs have many uses in medical diagnosis, ... Learn more|
Online Training: The Benefits of eLearning
- 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
- Tuition reimbursement: Some employers may reimburse for training expenses; check on your company's requirements
- Purchase orders (POs) accepted: If POs are required, request an invoice to start the procurement process
- Corporate LMS compatibility: 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 could 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.