Enrollment Period: 6 months.
Average Learning Time: ~120 minutes.
Additional Resources: Supplemental materials/activities.
Accredited Program: 2 CPD Credits.
Method of Training: Online / Self-paced eLearning.Accessibility: 24/7 access to all program materials.
Catalog: Pharmaceutical Regulatory Affairs.
Demonstration: Five (5) free trial courses are available.
Final Assessment: Multiple choice; unlimited attempts.
Certificate: PDF with validation code (See sample).
Price: $195.00 USD
Document your dedication to compliance, safety, and job performance by earning a training certification from Biopharma InstituteTraining Program: Regulatory Affairs: The Decentralised Procedure (DCP)
Training Provided By: Biopharma Institute
Schedule: Self-paced. Immediate access to training materials 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.
Certification Requirements: Students must view the entire program and successfully pass an online, multiple-choice final assessment within a 90-day/3-month period (180 day/6-month period for Professional Certification Programs). Certificate of completion is accessible in PDF format immediately after satisfying requirements.
Biopharma Institute's online training programs include immediate access after enrollment. Username, password, and instructions are emailed to the student following enrollment into the program. Course takers can attempt the final assessment any number of times, as needed, to achieve a passing score. Once all training requirements have been satisfied a certification of training has been achieved and can be verified immediately from our website using a unique certification ID code. The certificate of completion is also instantaneously launched and made available to the student in a PDF format upon completion. Professional certification programs additionally include a digital badge to verify training, and can be displayed on social networking sites, such as LinkedIn.
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.
Regulatory Affairs: The Decentralised Procedure (DCP) is included in the following professional certification programs:
Price: $1795.00 (USD) | Learn more
Benefits of Being Certified from Biopharma Institute: Throughout many of our online training programs students will be engaging in active learning through the use of interactive eLearning modules which have been developed to promote the retaining of key knowledge, access to references, case studies, and other important information necessary to assist with learning. Since 2003, Biopharma Institute has been aiding both professionals and corporations with their training requirements. Biopharma Institute certifications are recognized by a wide spectrum of industries and companies, and our training solutions are customizable to any organization's training needs. Today, Biopharma Institute offers over 200 courses training on clinical research, drug manufacturing, regulatory affairs, validation systems, pharmacovigilance, good clinical laboratory practice (GCLP), data integrity, and medical devices.
Employee / Corporate Training: For corporations seeking a method to train employees, economically, without having to set aside time for travel, webinars, or live, in-person training, Biopharma Institute is the training partner you can rely on. Our training provides an effective, engaging, self-paced learning experience which fits conveniently into the day-to-day activities of most types of learners. Our eLearning modules are SCORM-compliant and can be delivered from most corporate learning management systems (LMS). We catering to both small-scale (1-100 students) and large-scale (100+ students) training requests.
Online Training: The Benefits of Remote Learning & eLearning
- Immediate access to training: Instructions, username, password, and receipt of payment are 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 for professional certification programs for 180 days.
- Flexible final assessments: Assessment testing include multiple-choice questions and can be taken repeatedly until a passing score is achieved.
- Direct access to certificates: Certificate of completion is instantly available once course requirements have been fulfilled.
- Verification of training: Certificates can be verified online, and digital badges are issued for all Professional Certification programs.
- Tuition reimbursement: Some employers may reimburse for training expenses; check on your company's training reimbursement policy.
- Financial assistance: Payment plans are available to those who qualify. These are offered when paying electronic invoices, online. You must first request an invoice to be considered. Alternatively, purchasing individual courses one at a time is also an option.
- Purchase orders (POs) accepted: If a PO is required by your company, 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 provide an encrypted connection with firewall protection and daily scans for optimal level of security and performance.
- Career advancement: Professional certifications help demonstrate your interest and dedication to job performance, and may be helpful for those seeking a new career or transitioning to different positions within their organization.