Student Login |


Sunday, November 27, 2022
Home » Training Certification Courses

Regulatory Affairs for Pharmaceuticals, Medical Devices, and Clinical Research Training Certification Courses and Programs


Regulatory Affairs for Pharmaceuticals, Medical Devices, and Clinical ResearchDocument your dedication to regulatory affairs for pharmaceuticals, medical devices, and clinical research by earning a professional training certification from Biopharma Institute.

Choosing Biopharma Institute to train on how to maintain regulatory affairs for pharmaceuticals, medical devices, and clinical research compliance demonstrates your high priority on preserving quality and consumer protection. Employees earning a certificate of training from Biopharma Institute have established their value and understanding for the subject matter taught. Below is our list of regulatory affairs for pharmaceuticals, medical devices, and clinical research training certification courses and programs.

Regulatory Affairs:
Popular Programs & Training Categories


Regulatory Affairs Courses and Programs:

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

Global Pharmaceutical Regulatory Affairs Professional Certification Program

Course ID: PRA00A1
Average Learning Time: See Program Webpage
Price: $1795 | Learn more

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

US Pharmaceutical Regulatory Affairs Professional Certification Program

Course ID: PRA00B1
Average Learning Time: See Program Webpage
Price: $1295 | 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
Average Learning Time: 180 minutes
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
Average Learning Time: 90 minutes
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
Average Learning Time: 90 minutes
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
Average Learning Time: 150 minutes
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
Average Learning Time: 180 minutes
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
Average Learning Time: 180 minutes
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
Average Learning Time: 210 minutes
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
Average Learning Time: 30 minutes
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
Average Learning Time: 90 minutes
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
Average Learning Time: 120 minutes
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
Average Learning Time: 210 minutes
Price: $225 | Learn more

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

Regulatory Affairs: The Decentralized Procedure (DCP)

Course ID: PRA23
Average Learning Time: 120 minutes
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
Average Learning Time: 60 minutes
Price: $145 | Learn more

Regulatory Affairs for Medical Devices


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

Introduction to the Regulation of Medical Devices

Course ID: MDA0
Average Learning Time: 60 minutes
Price: $195 | Learn More

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

FDA Inspection Readiness for Professionals

Course ID: FDAINSP
Average Learning Time: See Program Webpage
Price: $495 | 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
Average Learning Time: See Program Webpage
Price: $1195 | 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
Average Learning Time: See Program Webpage
Price: $1295 | Learn More

Regulatory Affairs for Clinical Research


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

Clinical Trials Management Professional Certification Program (US & EU)

Course ID: GCP00A1
Average Learning Time: See Program Webpage
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
Average Learning Time: See Program Webpage
Price: $895 | Learn More

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

Clinical Trials: Preparing for an Audit or Inspection

Course ID: GCP006
Average Learning Time: 150 minutes
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
Average Learning Time: 180 minutes
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
Average Learning Time: 180 minutes
Price: $175 | Learn More

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

Course ID: CP015a
Average Learning Time: 60 minutes
Price: $199 | Learn More

Online Training – The Benefits of eLearning:

  • 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.

Name:
Company:
Phone:
Email:
 
Enter the number from the image above:
Comments:



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