Global Pharmaceutical Regulatory Affairs Professional Certification Program
Enrollment Period: 12 months.
Average Learning Time: ~20 - 29 hours.
Additional Resources: Supplemental materials/activities.
Method of Training: Online, asynchronous, self-paced eLearning.Accessibility: 24/7 access to all program materials.
Courses: Program includes 13 individual courses (see courses).
Outline/Syllabus: See individual course pages for outlines.
Digital Badge: Issued upon completion.
Post-nominal Letters: RAPro™.
Catalog: Pharmaceutical Regulatory Affairs.
Demonstration: Three (3) free trial courses are available.
Group/Employee Training: Click here to request a quote.
Final Assessment: Multiple choice; unlimited attempts.
Certificate: PDF with validation code (See sample).
Price: $1795.00 USD
Document your dedication to compliance, safety, and job performance by earning a professional certification.Training Provided By: Biopharma Institute
Outline/Syllabus: See individual course pages for outline.
The International Pharmaceutical Regulatory Affairs Professional Certification Program offers a foundation-level training which 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 maintain and gain approval to market medicinal products in Europe and the USA. The roles of major players and legal framework are presented.
The program move on to describe the life-cycle of a drug. The multiple procedures available for approval and assessment of products are described, and their requirements are discussed and described. Obligations which need to be filled for post-marketing approval are outlined.
As changes to procedures and regulations occur, this program is updated, and therefore, serves as a good reference tool allowing not only new users, but also experienced users, to stay updated with the broader picture of the environment of regulatory affairs.
This program includes details of the decentralized procedure (DCP), EU variations procedure, the mutual recognition procedure (MRP), the European centralized procedure (CP); requirements for obtaining approval for a new drug in the USA (the NDA process) and for obtaining FDA approval for a generic product in the USA (the ANDA); electronic common technological document (CTD); preparing submissions in the common technical document (CTD); orphan drug application in the US and EU; essentials for human medicinal products in US and EU; and registration of monoclonal antibodies.
Students participating in this program will be enrolled into the following thirteen (13) regulatory affairs courses, required for completing this program: 1) The Decentralized Procedure (DCP); 2) EU Variations Procedure; 3) The Mutual Recognition Procedure (MRP); 4) The European Centralized Procedure (CP); 5) The NDA Process: Requirements for Obtaining Approval for a New Drug in the USA; 6) The ANDA: Requirements for Obtaining FDA Approval for a Generic Product in the USA; 7) Electronic Common Technical Document (eCTD); 8) Preparing Submissions in the Common Technical Document (CTD) Form; 9) Orphan Drug Application- EU and US; 10) Essentials for Human Medicinal Products- EU and US; 11) Registration of Monoclonal Antibodies; 12) How to Gain Approval to Market Generic Drugs in the US; and 13) Submitting a New Drug Application (NDA) to Obtain Approval to Market in the US.
Global Pharmaceutical Regulatory Affairs Professional Certification Program includes these 13 individual courses:
Certification Requirements: Students must view the entire program and successfully pass an online, multiple-choice final assessment for each course within a 12-month period. Certificate of completion is accessible in PDF format immediately after satisfying the requirements.
Biopharma Institute certificates and digital badges include the date of completion, but do not have an expiration date. However, compliance training is typically considered valid for a period of 3 years. Many organizations suggest that compliance training should be refreshed at least every three years to stay up to date with regulations, standards, guidelines, and to reinforce the importance of maintaining compliance. The validity or recertification period for employee compliance training would be determined by those responsible for managing quality within the company.
Biopharma Institute's online training courses include immediate access after enrollment. Username, password, and instructions are emailed to the student following enrollment into any program or course. Students may attempt the final assessments any number of times, as needed, to achieve a passing score.
Once all training requirements have been satisfied a professional certification has been achieved and can be verified immediately from our website using a unique ID code located on the certificate. The professional certificate of completion is also instantaneously launched and made available to the student in a PDF format.
Additionally, once the student has completed the professional certification program, a digital badge is issued. The digital badge documents all the courses taken and completed within the program, to further validate the student's achievement. Digital badges can be displayed on social networking sites, such as LinkedIn, Facebook, Badgr, and others, to display accomplishments.
Benefits of Being Certified from Biopharma Institute: Throughout the online training courses students will be engaging in active learning using interactive eLearning modules developed to promote the retaining of key knowledge. Furthermore, students will be provided with access to references, the regulatory guidelines, case studies, and other important information necessary to gain a professional understanding for the discipline.
Since 2003, Biopharma Institute has been aiding both professionals and their corporate employers with attaining their training requirements. Our courses are developed by subject matter experts (SMEs) in the topic of study and have all been validated and/or accredited by a neutral 3rd party. Biopharma Institute certifications are recognized by regulators and companies in a wide range of industries around the world.
Biopharma Institute has training solutions which are customizable to any organization's training needs. We aim to provide only the highest quality of training, which is current, engaging, effective, and easy to navigate.
Today, Biopharma Institute has over 200+ courses in its catalog. These courses train on clinical trials, drug manufacturing, regulatory affairs, validation systems, drug safety, pharmacovigilance, good laboratory practice, and data integrity; all within the medical device, clinical research, and pharmaceutical industries.
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 cater to both small and large-scale training requests.
Benefits of Training with Biopharma Institute
|Immediate access to courses:||Username, password, instructions, and receipt of payment are immediately emailed upon online enrollment.|
|Self-paced, asynchronous eLearning:||24/7 access to all course materials and assessments for 12 months.|
|Open enrollment:||No prior course prerequisites or work experience required.|
|Expertise:||Courses developed by subject matter experts (SMEs) in the area being taught.|
|Current and validated:||Training is current with respect to regulations, procedures, and 3rd party validated and/or accredited.|
|Optimized for learning:||Courses include voiceovers, easy navigation, reading materials, case studies, progress checks, and high-quality animations to increase retention of subject matter.|
|Secure and safe access:||Encrypted website and LMS connections, firewall, and daily malware scans deliver optimal security and performance.|
|Flexible final assessments:||Multiple-choice questions can be taken repeatedly until a passing score is achieved.|
|Direct access to certificates:||Certificate of completion is instantly available once requirements have been fulfilled.|
|Verification of training:||Certificates verifiable online with digital badges issued for all professional certification programs.|
|Training manager access:||A proprietary portal offers access to download enrollment reports, training records, account balance, and more.|
|SCORM-compliant courses:||Courses can be delivered directly to most corporate Learning Management Systems (LMS).|
|Purchase orders (POs):||POs are accepted from all companies. Request an invoice when starting the procurement process.|
|Reimbursement:||Some employers may reimburse their employees for training expenses. Check your company's policy.|
|Financial assistance:||Payment plans are available to those who qualify. Alternatively, purchasing individual courses one at a time is also an option.|
|Career advancement:||Professional certifications help demonstrate interest and dedication to career and job performance. They may be helpful for those seeking to grow their career or transitioning to a different position within an organization. Professional certifications are a great addition to a resume, offer talking points for the interview, and practical knowledge for performing duties.|