Regulatory Affairs for Pharmaceuticals, Medical Devices, and Clinical Research Training Certification Courses and 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
- Introduction to the Regulation of Medical Devices
- Regulatory Affairs for Human Medicinal Products (EU and US)
- 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: PRA00A1Average Learning Time: See Program Webpage Price: $1795 | Learn more |
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US Pharmaceutical Regulatory Affairs Professional Certification ProgramCourse ID: PRA00B1Average Learning Time: See Program Webpage Price: $1295 | Learn more |
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Regulatory Affairs: Essentials for Human Medicinal Products – EU and USCourse ID: PRA01Average Learning Time: 180 minutes Price: $225 | Learn more |
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Regulatory Affairs: Orphan Drug Application – EU and USCourse ID: PRA02Average Learning Time: 90 minutes Price: $145 | Learn more |
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Regulatory Affairs: Preparing Submissions in the Common Technical Document (CTD) FormatCourse ID: PRA03Average Learning Time: 90 minutes Price: $145 | Learn more |
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Regulatory Affairs: Electronic Common Technical Document (eCTD)Course ID: PRA04Average Learning Time: 150 minutes Price: $225 | Learn more |
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Regulatory Affairs: Registration of Drugs Based on Monoclonal AntibodiesCourse ID: PRA05Average Learning Time: 180 minutes Price: $225 | Learn more |
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Regulatory Affairs: How to Gain Approval to Market Generic Drugs in the USCourse ID: PRA06Average Learning Time: 180 minutes Price: $225 | Learn more |
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Regulatory Affairs: Submitting a New Drug Application (NDA) to Obtain Approval to Market in the USCourse ID: PRA07Average Learning Time: 210 minutes Price: $225 | Learn more |
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Regulatory Affairs: The Regulatory Pathway to Licensing Follow-on Biologics (Biosimilars) in the USACourse ID: PRA08Average Learning Time: 30 minutes Price: $115 | Learn more |
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Regulatory Affairs: The European Centralized Procedure (CP)Course ID: PRA20Average Learning Time: 90 minutes Price: $145 | Learn more |
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Regulatory Affairs: The Mutual Recognition Procedure (MRP)Course ID: PRA21Average Learning Time: 120 minutes Price: $195 | Learn more |
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Regulatory Affairs: Variations to Marketing Authorizations in EuropeCourse ID: PRA22Average Learning Time: 210 minutes Price: $225 | Learn more |
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Regulatory Affairs: The Decentralized Procedure (DCP)Course ID: PRA23Average Learning Time: 120 minutes Price: $195 | Learn more |
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Regulatory Affairs: Essentials of Monoclonal AntibodiesCourse ID: PRA24Average Learning Time: 60 minutes Price: $145 | Learn more |
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Regulatory Affairs for Medical Devices
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Introduction to the Regulation of Medical DevicesCourse ID: MDA0Average Learning Time: 60 minutes Price: $195 | Learn More |
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FDA Inspection Readiness for ProfessionalsCourse ID: FDAINSPAverage Learning Time: See Program Webpage Price: $495 | Learn More |
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Medical Device Single Audit Program (MDSAP) for ProfessionalsCourse ID: MDSAPAverage Learning Time: See Program Webpage Price: $1195 | Learn More |
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EU Medical Device Regulation (EU MDR) for ProfessionalsCourse ID: EUMDRAverage Learning Time: See Program Webpage Price: $1295 | Learn More |
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Regulatory Affairs for Clinical Research
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Clinical Trials Management Professional Certification Program (US & EU)Course ID: GCP00A1Average Learning Time: See Program Webpage Price: $1295 | Learn More |
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Obtaining Approval for Clinical Trials in US & EU for Regulatory ProfessionalsCourse ID: GCP00A2Average Learning Time: See Program Webpage Price: $895 | Learn More |
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Clinical Trials: Preparing for an Audit or InspectionCourse ID: GCP006Average Learning Time: 150 minutes Price: $225 | Learn More |
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Clinical Trials: Application Process to Conduct FDA-regulated Clinical Trials in USACourse ID: GCP007Average Learning Time: 180 minutes Price: $225 | Learn More |
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Clinical Trials: How to Obtain Approval to Conduct Clinical Trials in the EUCourse ID: GCP020Average Learning Time: 180 minutes Price: $175 | Learn More |
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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: CP015aAverage Learning Time: 60 minutes Price: $199 | Learn More |
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Online Training – The Benefits of eLearning:
- Immediate access to courses: Instructions, username, password, and receipt of payment are emailed instantly upon online enrollment.
- Self-paced, asynchronous eLearning: 24/7 access to individual courses for 6 months and 1 year for professional certification programs.
- Expertise: Courses have been developed by subject matter experts (SMEs) in the area of material being taught.
- Current and validated: Courses are current with respect to regulations, procedures, and are 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: Website and LMS provide an encrypted connection, including firewall protection and daily scans for malware, to deliver optimal level of security and performance.
- Flexible final assessments: Assessments 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 requirements have been fulfilled.
- Verification of training: Certificates can be verified online, and digital badges are issued for all professional certification programs.
- Training manager access: Our proprietary Training Manager Portal offers managers access to download their group enrollments, training records, account balance, and so much more.
- SCORM-compliant courses: Courses can be delivered directly from most corporate Learning Management Systems (LMS).
- Purchase orders (POs): POs are accepted from all companies. You must request an invoice to start the procurement process.
- Reimbursement: Some employers may reimburse their employees for training expenses. Check your company’s education reimbursement policy.
- Financial assistance: Payment plans are available to those who qualify. These are offered when paying electronic invoices, online. Alternatively, purchasing individual courses one at a time is also an option.
- Career advancement: Professional certifications help demonstrate interest and dedication to your career and job performance. They may be helpful for those seeking a new career or transitioning to a different position within an organization. Professional certifications are a great addition to a resume, offer taking points for the interview, and practical knowledge for performing the work.