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Thursday, September 23, 2021
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Regulatory Affairs: Pharmaceuticals, Medical Devices, and Clinical ResearchRegulatory Affairs: Pharmaceuticals, Medical Devices, and Clinical Research Training and Professional Certification Programs


Document a dedication to your career and job performance by earning a certification from Biopharma Institute.

Biopharma Institute offers a catalog of over 200 programs for pharmaceutical, medical device, and clinical research professionals. Below is our list of Pharmaceutical Regulatory Affairs training courses and professional certification programs:


Certification Training GCP Training: ICH E6(R2), An Abridged Course  Free Trial Course: 

GCP Training: ICH E6(R2), An Abridged Course

Course ID: CP002a00
Free Course: Start Learning, Today! Learn more

Certification Training US Pharmaceutical Regulatory Affairs Professional Certification Program  Professional Certification Program: 

US Pharmaceutical Regulatory Affairs Professional Certification Program

Course ID: PRA00B1
Price: $1295 | Learn more

Certification Training International Pharmaceutical Regulatory Affairs Professional Certification Program  Professional Certification Program: 

International Pharmaceutical Regulatory Affairs Professional Certification Program

Course ID: PRA00A1
Price: $1795 | Learn more

Certification Training Clinical Trials Management (US & EU) Professional Certification Program  Professional Certification Program: 

Clinical Trials Management (US & EU) Professional Certification Program

Course ID: GCP00A1
Price: $1295 | Learn more

Certification Training Obtaining Approval for Clinical Trials in US & EU for Regulatory Professionals  Training Program for Professionals: 

Obtaining Approval for Clinical Trials in US & EU for Regulatory Professionals

Course ID: GCP00A2
Price: $895 | Learn more

Certification Training GCP: Preparing for an Audit or Inspection  Individual Course w/Certificate of Completion: 

GCP: Preparing for an Audit or Inspection

Course ID: GCP006
Price: $225 | Learn more

Certification Training Clinical Trials: Application Process to Conduct FDA-regulated Clinical Trials in USA  Individual Course w/Certificate of Completion: 

Clinical Trials: Application Process to Conduct FDA-regulated Clinical Trials in USA

Course ID: GCP007
Price: $225 | Learn more

Certification Training Clinical Trials:  How to Obtain Approval to Conduct Clinical Trials in the EU  Individual Course w/Certificate of Completion: 

Clinical Trials: How to Obtain Approval to Conduct Clinical Trials in the EU

Course ID: GCP020
Price: $175 | Learn more

Certification Training Overview of 21 CFR 312 Investigational New Drug Application (IND) and 21 CFR 314 Application for FDA Approval to Market a New Drug (NDA)  Individual Course w/Certificate of Completion: 

Overview of 21 CFR 312 Investigational New Drug Application (IND) and 21 CFR 314 Application for FDA Approval to Market a New Drug (NDA)

Course ID: CP015a
Price: $199 | Learn more

Certification Training Regulatory Affairs: Essentials for Human Medicinal Products - EU and US  Individual Course w/Certificate of Completion: 

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

Course ID: PRA01
Price: $225 | Learn more

Certification Training Regulatory Affairs: Orphan Drug Application - EU and US  Individual Course w/Certificate of Completion: 

Regulatory Affairs: Orphan Drug Application – EU and US

Course ID: PRA02
Price: $145 | Learn more

Certification Training Regulatory Affairs: Preparing Submissions in the Common Technical Document (CTD) Format  Individual Course w/Certificate of Completion: 

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

Course ID: PRA03
Price: $145 | Learn more

Certification Training Regulatory Affairs: Electronic Common Technical Document (eCTD)  Individual Course w/Certificate of Completion: 

Regulatory Affairs: Electronic Common Technical Document (eCTD)

Course ID: PRA04
Price: $225 | Learn more

Certification Training Regulatory Affairs: Registration of Drugs Based on Monoclonal Antibodies  Individual Course w/Certificate of Completion: 

Regulatory Affairs: Registration of Drugs Based on Monoclonal Antibodies

Course ID: PRA05
Price: $225 | Learn more

Certification Training Regulatory Affairs: How to Gain Approval to Market Generic Drugs in the US  Individual Course w/Certificate of Completion: 

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

Course ID: PRA06
Price: $225 | Learn more

Certification Training Regulatory Affairs: Submitting a New Drug Application (NDA) to Obtain Approval to Market in the US  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
Price: $225 | Learn more

Certification Training Regulatory Affairs: The Regulatory Pathway to Licensing Follow-on Biologics (Biosimilars) in the USA  Individual Course w/Certificate of Completion: 

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

Course ID: PRA08
Price: $115 | Learn more

Certification Training Regulatory Affairs: The European Centralized Procedure (CP)  Individual Course w/Certificate of Completion: 

Regulatory Affairs: The European Centralized Procedure (CP)

Course ID: PRA20
Price: $145 | Learn more

Certification Training Regulatory Affairs: The Mutual Recognition Procedure (MRP)  Individual Course w/Certificate of Completion: 

Regulatory Affairs: The Mutual Recognition Procedure (MRP)

Course ID: PRA21
Price: $195 | Learn more

Certification Training Regulatory Affairs: Variations to Marketing Authorizations in Europe  Individual Course w/Certificate of Completion: 

Regulatory Affairs: Variations to Marketing Authorizations in Europe

Course ID: PRA22
Price: $225 | Learn more

Certification Training Regulatory Affairs: The Decentralised Procedure (DCP)  Individual Course w/Certificate of Completion: 

Regulatory Affairs: The Decentralised Procedure (DCP)

Course ID: PRA23
Price: $195 | Learn more

Certification Training Regulatory Affairs: Essentials of Monoclonal Antibodies  Individual Course w/Certificate of Completion: 

Regulatory Affairs: Essentials of Monoclonal Antibodies

Course ID: PRA24
Price: $145 | Learn more

Medical Device Regulatory Affairs Programs

Certification Training 21 CFR Part 820: Medical Device cGMP Professional Certification Program  Professional Certification Program: 

21 CFR Part 820: Medical Device cGMP Professional Certification Program

Course ID: MDPRO
Price: $2495 | Learn More

Certification Training ISO 13485:2016 Professional Certification Program  Professional Certification Program: 

ISO 13485:2016 Professional Certification Program

Course ID: ISOPCRT
Price: $1295 | Learn More

Certification Training ISO 14971:2019 for Professionals  Training Program for Professionals: 

ISO 14971:2019 for Professionals

Course ID: ISOPRO
Price: $339 | Learn More

Certification Training EU Medical Device Regulation (EU MDR) for Professionals  Training Program for Professionals: 

EU Medical Device Regulation (EU MDR) for Professionals

Course ID: EUMDR
Price: $1295 | Learn More

Certification Training Medical Device Single Audit Program (MDSAP) for Professionals  Training Program for Professionals: 

Medical Device Single Audit Program (MDSAP) for Professionals

Course ID: MDSAP
Price: $1195 | Learn More

Certification Training FDA Inspection Readiness for Professionals  Training Program for Professionals: 

FDA Inspection Readiness for Professionals

Course ID: FDAINSP
Price: $495 | Learn More

Certification Training MedDev: Introduction to the Regulation of Medical Devices  Individual Course w/Certificate of Completion: 

MedDev: Introduction to the Regulation of Medical Devices

Course ID: MDA0
Price: $195 | Learn More

Color Key – Types of Programs:

 Professional Certification Programs:  These programs are intended for experienced professionals. Professional certification programs provide a curriculum which offers a detailed and comprehensive dive into the particular subject matter. Students completing these programs have demonstrated a professional level of competence for the particular subject matter and will receive a professional certification and digital badge upon successful completion.

 Training Programs for Professionals:  These programs are intended for professionals. This is a professional certification program which provides a specific curriculum offering a detailed and comprehensive dive into the subject matter. Students completing these programs have demonstrated a professional competence for the particular subject matter and will receive a professional certification and digital badge upon successful completion.

 Individual Courses w/Certificate of Completion:  These are individual courses intended for professionals. These courses provide a specific training offering a strong understanding for the subject matter. Students completing these courses have demonstrated a comprehension for the particular subject matter.


Online Training – The Benefits of 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.