Internationally Accredited Training Courses
Many of Biopharma Institute’s clinical research, regulatory affairs, cGMP, validation, and drug safety courses are internationally accredited by the Faculty of Pharmaceutical Medicine of the Royal Colleges of Physicians of the United Kingdom, and offer Continuing Professional Development (CPD) points. On completion of each course, learners earn CPD points in proportion to the course’s duration. The CPD points earned are specified on the certificate awarded to the learner on successful completion of the course’s multiple-choice-question assessment. Below you will find a list of the courses which offer CPD points upon completion.
CME, CEU, and CPE Credits: Most credentialing centers in the US and abroad will transfer CPD points to units such as CME credits (for medical doctors), CEU credits (for nurses), or CPE credits (for pharmacists). However, we suggest you reach out to your local medical licensing board to confirm before purchasing the training if this is a desire. Each medical licensing board has different guidelines regarding the transfer of units.
Accredited Training Programs Offering CPD Credits:
- Change Control
- Clinical Trials Management and Monitoring
- Computer System Validation (CSV)
- Contamination Control
- Data Integrity
- Drug Safety
- Electronic Records
- Good Documentation Practices
- Good Laboratory Practices
- Good Manufacturing Practices
- Medical Devices
- Pharmaceutical Microbiology
- Pharmaceutical Regulatory Affairs
- Pharmaceutical Sales and Marketing
- Validation for BioPharma Companies
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GCP: ICH-GCP Good Clinical PracticeCourse ID: GCP001 |
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Clinical Trials: Preparation and DesignCourse ID: GCP002 |
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Clinical Trials and Drug DevelopmentCourse ID: GCP003 |
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Clinical Trial Monitoring: Site Evaluation and Set-upCourse ID: GCP004 |
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Clinical Trial Monitoring: Documentation and ClosureCourse ID: GCP005 |
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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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Clinical Trials: How to Gain Authorization for Clinical Research Under the EU Clinical Trials RegulationCourse ID: CT11 |
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Clinical Trials: How to Conduct Clinical Research Under the EU Clinical Trials RegulationCourse ID: CT12 |
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Validation: Computer System Validation (Part 1 of 2) (Planning)Course ID: VAL09 |
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Validation: Computer System Validation (Part 2 of 2) (Implementation)Course ID: VAL10 |
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Introduction to Drug Safety and PharmacovigilanceCourse ID: AV02 |
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Drug Safety: Signal Detection and Management in PharmacovigilanceCourse ID: PV04 |
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Drug Safety: Risk Management Planning for Medicinal ProductsCourse ID: PV05 |
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Drug Safety: Urgent Safety RestrictionsCourse ID: PV06 |
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Drug Safety: Good Pharmacoepidemiology PracticeCourse ID: PV07 |
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Safety Reporting in Clinical Trials (Adverse Event Reporting)Course ID: CT13 |
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Clinical Trial Safety Reporting Requirements in the EU and USACourse ID: CT14 |
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Introduction to Pharmacokinetics and Pharmacodynamics in Drug Development and RegistrationCourse ID: PKPD01 |
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Conducting Pharmacokinetic and Pharmacodynamic StudiesCourse ID: PKPD02 |
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Compliance with Regulation 21 CFR Part 11 (Electronic Records and Electronic Signatures)Course ID: ESR01A |
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cGMP: Introduction to Good Manufacturing Practice for Medicinal ProductsCourse ID: CGMP01 |
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cGMP: Good Documentation Practice (GDocP)Course ID: CGMP02 |
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cGMP: Good Manufacturing Practice in Cleaning and SanitationCourse ID: CGMP03 |
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cGMP: Good Manufacturing Practice for the WarehouseCourse ID: CGMP04 |
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cGMP: Good Manufacturing Practice in Processing Medicinal ProductsCourse ID: CGMP05 |
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cGMP: Good Manufacturing Practice in Packaging Medicinal ProductsCourse ID: CGMP06 |
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cGMP: Corrective and Preventive Action (CAPA) in Medicinal Product Manufacturing – Including Root Cause AnalysisCourse ID: CGMP07 |
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Introduction to the Regulation of Medical DevicesCourse ID: MDA0 |
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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 |
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The Biologics License Application (BLA) for Marketing Approval in the USACourse ID: SUB15 |
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The 505(b)(2) Application for Marketing Approval in the USACourse ID: SUB16 |
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Pharmaceutical Sales & Marketing: Legal and Regulatory Framework for Advertising and Promotion of Prescription Drugs in the USACourse ID: SAM01 |
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Pharmaceutical Sales & Marketing: Regulatory Requirements and Guidance on Advertising and Promotion of Prescription Drugs in the USACourse ID: SAM02 |
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Pharmaceutical Sales & Marketing: Consumer-directed Advertising and Online Promotion of Prescription Drugs in the USACourse ID: SAM03 |
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Pharmaceutical Sales & Marketing: Marketing of Prescription Drugs in the USA- Interactions with Healthcare ProfessionalsCourse ID: SAM04 |
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Validation: Introduction to ValidationCourse ID: VAL01 |
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Validation: Plans and DocumentationCourse ID: VAL02 |
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Validation: Commissioning and Installation Qualification (IQ)Course ID: VAL03 |
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Validation: Operational and Performance Qualification (OQ/PQ)Course ID: VAL04 |
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Validation: Equipment Cleaning ValidationCourse ID: VAL08 |
Online Training Benefits:
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. |