Regulatory Affairs for Pharmaceuticals, Medical Devices, and Clinical Research Training Courses and Certification Programs
Document 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 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
Popular Programs & Training Categories
- Professional Certifications:
- Global Pharmaceutical Regulatory Affairs Professional Certification Program
- US Pharmaceutical Regulatory Affairs Professional Certification Program
- Clinical Trials Management (US & EU) Professional Certification Program
- Obtaining Approval for Clinical Trials in US & EU for Professionals
- EU MDR: EU Medical Device Regulation for Professionals
- Medical Device Single Audit Program (MDSAP) for Professionals
- Regulatory Affairs for Medical Devices
- Regulatory Affairs for Pharmaceuticals
- Regulatory Affairs for Clinical Trials
- MRP – The Mutual Recognition Procedure
- CTD – Preparing Submissions in the Common Technical Document Format
- eCTD – Electronic Common Technical Document
- DCP – The Decentralized Procedure
- NDA – Submitting a New Drug Application: Obtain Approval to Market in the US
- Registration of Drugs Based on Monoclonal Antibodies
- How to Gain Approval to Market Generic Drugs in the US
- The Regulatory Pathway to Licensing Follow-on Biologics (Biosimilars) in the USA
Subcategories (Areas of specialty or focus):
Regulatory Affairs Courses and Programs:
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Global Pharmaceutical Regulatory Affairs Professional Certification ProgramCourse ID: PRA00A1 |
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US Pharmaceutical Regulatory Affairs Professional Certification ProgramCourse ID: PRA00B1 |
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Regulatory Affairs: Essentials for Human Medicinal Products – EU and USCourse ID: PRA01 |
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Regulatory Affairs: Orphan Drug Application – EU and USCourse ID: PRA02 |
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Regulatory Affairs: Preparing Submissions in the Common Technical Document (CTD) FormatCourse ID: PRA03 |
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Regulatory Affairs: Electronic Common Technical Document (eCTD)Course ID: PRA04 |
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Regulatory Affairs: Registration of Drugs Based on Monoclonal AntibodiesCourse ID: PRA05 |
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Regulatory Affairs: How to Gain Approval to Market Generic Drugs in the USCourse ID: PRA06 |
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Regulatory Affairs: Submitting a New Drug Application (NDA) to Obtain Approval to Market in the USCourse ID: PRA07 |
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Regulatory Affairs: The Regulatory Pathway to Licensing Follow-on Biologics (Biosimilars) in the USACourse ID: PRA08 |
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Regulatory Affairs: The European Centralized Procedure (CP)Course ID: PRA20 |
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Regulatory Affairs: The Mutual Recognition Procedure (MRP)Course ID: PRA21 |
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Regulatory Affairs: Variations to Marketing Authorizations in EuropeCourse ID: PRA22 |
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Regulatory Affairs: The Decentralized Procedure (DCP)Course ID: PRA23 |
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Regulatory Affairs: Essentials of Monoclonal AntibodiesCourse ID: PRA24 |
Regulatory Affairs for Medical Devices
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Introduction to the Regulation of Medical DevicesCourse ID: MDA0 |
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FDA Inspection Readiness for GMP Auditors and ProfessionalsCourse ID: FDAINSP |
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Medical Device Single Audit Program (MDSAP) for ProfessionalsCourse ID: MDSAP |
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EU Medical Device Regulation (EU MDR) for ProfessionalsCourse ID: EUMDR |
Regulatory Affairs for Clinical Research
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Clinical Trials Management (US & EU) Professional Certification ProgramCourse ID: GCP00A1 |
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Obtaining Approval for Clinical Trials in US & EU for Regulatory ProfessionalsCourse ID: GCP00A2 |
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Clinical Trials: Preparing for an Audit or InspectionCourse ID: GCP006 |
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Clinical Trials: The Investigational New Drug Application (IND) to Conduct FDA-regulated Clinical TrialsCourse ID: GCP007 |
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Clinical Trials: How to Obtain Approval to Conduct Clinical Trials in the EUCourse ID: GCP020 |
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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 |
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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.
