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Wednesday, December 01, 2021
Home » US Pharmaceutical Regulatory Affairs Professional Certification Program

US Pharmaceutical Regulatory Affairs Professional Certification Program

Certification Training
 
Rated 4.26/5
19 reviews
Program/Course ID: PRA00B1
Enrollment Period: 12 months (1 year).
Average Learning Time: ~12 - 18 hours.
Additional Resources: Supplemental materials/activities.
Method of Training: Online / Self-paced eLearning.
Accessibility: 24/7 access to all program materials.
Courses: Program includes 8 individual courses (see below).
Digital Badge: Issued upon completion.
Post-nominal Letters: RAPro™.
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: $1295.00 USD  

Document your dedication to compliance, safety, and job performance by earning a professional certification from Biopharma Institute

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

Description:

This online professional certification program describes the essential requirements for obtaining approval of a new drug in the USA, the 'NDA Process'. The program describes preparing submissions using the Common Technical Document (CTD) Form and requirements for obtaining approval of human medicinal products in the US.

Courses included in this program are: 1) Essentials for Human Medicinal Products; 2) Orphan Drug Application; 3) How to Gain Approval to Market Generic Drugs in the US; 4) Submitting a New Drug Application (NDA) to Obtain Approval to Market in the US; 5) Preparing Submissions in the Common Technical Document (CTD) Format; 6) Electronic Common Technical Document (eCTD); 7) The Regulatory Pathway to Licensing Follow-on Biologics (Biosimilars) in the USA; and 8) Registration of Drugs Based on Monoclonal Antibodies.


US Pharmaceutical Regulatory Affairs Professional Certification Program includes these courses:



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

Additional Details:

Certification Requirements: Students must view the entire program and successfully pass online, multiple-choice final assessments for each course within a 180 day/6-month period. Certificate of completion is accessible in PDF format immediately after satisfying the 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. Program enrollees can 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 certification ID code. The professional 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 validate the training achieved. Digital badges can be displayed on social networking sites, such as LinkedIn.

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.


Contact Us:

For additional information on our training programs, to request a quote/invoice, or suggest a course, complete the form below or call toll free in the US/Canada: (888) 4-BIO-LRN. Callers from outside the US can dial +1 (201) 301-8370.

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