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Tuesday, March 19, 2024
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Regulatory Affairs for Pharmaceuticals, Medical Devices, and Clinical Research Training Courses and Certification 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 certification from Biopharma Institute.

Choosing Biopharma Institute to provide training on regulatory affairs for pharmaceuticals, medical devices, and clinical research demonstrates the importance you place on receiving a reliable, accurate, and high-quality instruction with an emphasis on producing products or services which are safe for the consumers or patients to use. Students earning a certificate of training from Biopharma Institute have an established appreciation for regulatory and compliance and have presented a strong understanding of 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
Method of Training: Online, self-paced eLearning.
Price: $1795.00


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

US Pharmaceutical Regulatory Affairs Professional Certification Program

Course ID: PRA00B1
Method of Training: Online, self-paced eLearning.
Price: $1295.00


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
Method of Training: Online, self-paced eLearning.
Length: 180 minutes
Price: $225.00


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
Method of Training: Online, self-paced eLearning.
Length: 90 minutes
Price: $145.00


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
Method of Training: Online, self-paced eLearning.
Length: 90 minutes
Price: $145.00


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
Method of Training: Online, self-paced eLearning.
Length: 150 minutes
Price: $225.00


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
Method of Training: Online, self-paced eLearning.
Length: 180 minutes
Price: $225.00


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
Method of Training: Online, self-paced eLearning.
Length: 180 minutes
Price: $225.00


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
Method of Training: Online, self-paced eLearning.
Length: 210 minutes
Price: $225.00


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
Method of Training: Online, self-paced eLearning.
Length: 30 minutes
Price: $115.00


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
Method of Training: Online, self-paced eLearning.
Length: 90 minutes
Price: $145.00


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
Method of Training: Online, self-paced eLearning.
Length: 120 minutes
Price: $195.00


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
Method of Training: Online, self-paced eLearning.
Length: 210 minutes
Price: $225.00


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

Regulatory Affairs: The Decentralized Procedure (DCP)

Course ID: PRA23
Method of Training: Online, self-paced eLearning.
Length: 120 minutes
Price: $195.00


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

Regulatory Affairs: Essentials of Monoclonal Antibodies

Course ID: PRA24
Method of Training: Online, self-paced eLearning.
Length: 60 minutes
Price: $145.00


Certification Training The Biologics License Application (BLA) for Marketing Approval in the USA
Individual Course w/Certificate of Completion:

The Biologics License Application (BLA) for Marketing Approval in the USA

Course ID: SUB15
Method of Training: Online, self-paced eLearning.
Length: 210 minutes
Price: $225.00


Certification Training The 505(b)(2) Application for Marketing Approval in the USA
Individual Course w/Certificate of Completion:

The 505(b)(2) Application for Marketing Approval in the USA

Course ID: SUB16
Method of Training: Online, self-paced eLearning.
Length: 30 minutes
Price: $145.00


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
Method of Training: Online, self-paced eLearning.
Length: 60 minutes
Price: $195.00


Regulatory Affairs for Clinical Research


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

Clinical Trials Management (US & EU) Professional Certification Program

Course ID: GCP00A1
Method of Training: Online, self-paced eLearning.
Price: $1295.00


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
Method of Training: Online, self-paced eLearning.
Price: $895.00


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
Method of Training: Online, self-paced eLearning.
Length: 150 minutes
Price: $225.00


Certification Training Clinical Trials: The Investigational New Drug Application (IND) to Conduct FDA-regulated Clinical Trials
Individual Course w/Certificate of Completion:

Clinical Trials: The Investigational New Drug Application (IND) to Conduct FDA-regulated Clinical Trials

Course ID: GCP007
Method of Training: Online, self-paced eLearning.
Length: 180 minutes
Price: $225.00


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
Method of Training: Online, self-paced eLearning.
Length: 180 minutes
Price: $175.00


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
Method of Training: Online, self-paced eLearning.
Length: 60 minutes
Price: $199.00



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Online Training – The Benefits of eLearning:

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: Upon completion, certificates are immediately issued in an encrypted PDF format. Certificates include a watermark, unique validation code, and QR verification barcode.
Verification of training: Certificates are verifiable online using QR barcode or the unique ID code. Digital badges are additionally 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.


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.