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Home » Global Pharmaceutical Regulatory Affairs Professional Certification Program

Global Pharmaceutical Regulatory Affairs Professional Certification Program

Certification Training
 
Rated 4.1 / 5
21 reviews
Program/Course ID: PRA00A1
Enrollment Period: 12 months (1 year).
Average Learning Time: ~20 - 29 hours.
Additional Resources: Supplemental materials/activities.
Method of Training: Online / 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: Five (5) 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.

Biopharma Institute ReviewsTraining Provided By: Biopharma Institute
Website: https://www.biopharmainstitute.com

Outline/Syllabus: See individual course pages for outline.
Description:

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:

(Click on course links below to see outline/syllabus)



Individual Course w/Certificate of Completion:

Regulatory Affairs: Essentials for Human Medicinal Products - EU and US

Course ID: PRA01
Duration: 180 minutes (3 CPD Credits)
Price: Included | Learn more

Individual Course w/Certificate of Completion:

Regulatory Affairs: Orphan Drug Application - EU and US

Course ID: PRA02
Duration: 90 minutes (1.5 CPD Credits)
Price: Included | Learn more

Individual Course w/Certificate of Completion:

Regulatory Affairs: Preparing Submissions in the Common Technical Document (CTD) Format

Course ID: PRA03
Duration: 90 minutes (1.5 CPD Credits)
Price: Included | Learn more

Individual Course w/Certificate of Completion:

Regulatory Affairs: Electronic Common Technical Document (eCTD)

Course ID: PRA04
Duration: 150 minutes (2.5 CPD Credits)
Price: Included | Learn more

Individual Course w/Certificate of Completion:

Regulatory Affairs: Registration of Drugs Based on Monoclonal Antibodies

Course ID: PRA05
Duration: 180 minutes (3 CPD Credits)
Price: Included | Learn more

Individual Course w/Certificate of Completion:

Regulatory Affairs: How to Gain Approval to Market Generic Drugs in the US

Course ID: PRA06
Duration: 180 minutes (3 CPD Credits)
Price: Included | Learn more

Individual Course w/Certificate of Completion:

Regulatory Affairs: Submitting a New Drug Application (NDA) to Obtain Approval to Market in the US

Course ID: PRA07
Duration: 210 minutes (3.5 CPD Credits)
Price: Included | Learn more

Individual Course w/Certificate of Completion:

Regulatory Affairs: The Regulatory Pathway to Licensing Follow-on Biologics (Biosimilars) in the USA

Course ID: PRA08
Duration: 30 minutes (0.5 CPD Credits)
Price: Included | Learn more

Individual Course w/Certificate of Completion:

Regulatory Affairs: The European Centralized Procedure (CP)

Course ID: PRA20
Duration: 90 minutes (1.5 CPD Credits)
Price: Included | Learn more

Individual Course w/Certificate of Completion:

Regulatory Affairs: The Mutual Recognition Procedure (MRP)

Course ID: PRA21
Duration: 120 minutes (2 CPD Credits)
Price: Included | Learn more

Individual Course w/Certificate of Completion:

Regulatory Affairs: Variations to Marketing Authorizations in Europe

Course ID: PRA22
Duration: 210 minutes (3.5 CPD Credits)
Price: Included | Learn more

Individual Course w/Certificate of Completion:

Regulatory Affairs: The Decentralized Procedure (DCP)

Course ID: PRA23
Duration: 120 minutes (2 CPD Credits)
Price: Included | Learn more

Individual Course w/Certificate of Completion:

Regulatory Affairs: Essentials of Monoclonal Antibodies

Course ID: PRA24
Duration: 60 minutes (1 CPD Credits)
Price: Included | Learn more

Additional Information:

Certification Requirements: Students must view the entire program and successfully pass an online, multiple-choice final assessments 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 the accomplishment.

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 catering to both small and large-scale training requests.


Benefits of Training with Biopharma Institute

  • Immediate access to training: Instructions, username, password, and receipt of payment are emailed instantly upon online enrollment.
  • Self-paced courses: 24/7 access to individual courses for 6 months and 1 year for professional certification programs.
  • Expertise: All courses have been developed by subject matter experts (SMEs) in the area of material being taught.
  • Current and validated: All courses are current with respect to regulations and procedures, and are 3rd party validated and/or accredited.
  • Optimized for learning: Courses include voiceovers, easy navigation, case studies, progress checks, and high-quality animations to increase retention of subject matter.
  • Secure and safe access: Website and LMS provide an encrypted connection with firewall protection and daily scans for malware to deliver optimal level of security and performance.
  • Training manager access: Our proprietary Training Manager Portal offers managers access to download their group enrollments, training records, account balance, and so much more.
  • Purchase orders (POs): If issuing 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.
  • Reimbursement: Some employers may reimburse for training expenses. Check 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.
  • Flexible final assessments: Assessments include multiple-choice questions and can be taken repeatedly until a passing score is achieved.
  • Career advancement: Professional certifications help demonstrate your interest and dedication to your career and job performance. They may be helpful for those seeking a new career or transitioning to different positions within their organization.
  • Direct access to certificates: Certificate of completion is instantly available once requirements have been fulfilled.
  • Verification of training: Certificates can be verified online, and digital badges are issued for all professional certification programs.


Have Questions? Contact Us:

Use the form below if you would like more information on our programs. You may want to request a quote on group training or an invoice for generating a company purchase order. For quotes or invoices please provide the course(s) and number of students. Alternatively, call toll-free from the US or Canada: +1 (888) 424-6576. International callers may dial: +1 (201) 301-8370.

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For quotes or invoices please provide the course(s) and number of students.