The BioPharma Learning Center is an initiative of Pharma Research, a global leader in clinical research training and certification provider. It offers globally recognized, industry-oriented pharma courses in regional languages to support career growth. These programs meet real industry standards and are accredited by International Accreditation Council for Clinical Research and Education (IACCRE), helping learners build successful careers in the global pharmaceutical industry.
BioPharma Learning Center Pharma Research की एक पहल है, जो क्लिनिकल रिसर्च प्रशिक्षण और प्रमाणन में वैश्विक अग्रणी संस्था है। यह क्षेत्रीय भाषाओं में वैश्विक मान्यता प्राप्त, उद्योग-उन्मुख फार्मा कोर्स प्रदान करता है। ये कार्यक्रम उद्योग मानकों के अनुरूप हैं और International Accreditation Council for Clinical Research and Education (IACCRE) द्वारा मान्यता प्राप्त हैं, जो शिक्षार्थियों को फार्मास्यूटिकल उद्योग में सफल करियर बनाने में मदद करते हैं।
| Module 1 | Introduction to Clinical Research & Drug Development |
|---|---|
| Unit 1 | Chapter 1 – Lesson 1.2: Phases of Drug Development (Pre-clinical to Post-marketing) |
| Unit 2 | Chapter 1 – Lesson 1.3: Types of Clinical Trials (Interventional vs. Observational) |
| Unit 3 | Chapter 1 – Lesson 1.4: Key Stakeholders in Clinical Research: Sponsor, CRO, Investigator, IRB/IEC and RA |
| Module 2 | Chapter 2 — ICH-GCP and Quality Management |
| Unit 1 | Clinical research- Chapter2- Lesson 2.1 |
| Unit 2 | Clinical research- Chapter2- Lesson 2.3 |
| Unit 3 | Clinical research- Chapter2- Lesson 2.4 |
| Unit 4 | Clinical research- Chapter2- Lesson 2.5 |
| Module 3 | Chapter 3 — Ethics, GCP and Essential Trial Documents |
| Unit 1 | Chapter 3 – Lesson 3.1: Ethical Principles |
| Unit 2 | Chapter 3 – Lesson 3.2: GCP Principles — Data Integrity |
| Unit 3 | Chapter 3 – Lesson 3.3: Trial Processes Proportionate to Risk |
| Unit 4 | Chapter 3 – Lesson 3.4: Essential Documents for Conducting a Trial |
| Module 4 | Chapter 4 — Clinical Trial Protocol and Design |
| Unit 1 | Chapter 4 – Lesson 4.1: Clinical Trial Protocol, Design and Methodology |
| Unit 2 | Chapter 4 – Lesson 4.2: Protocol Components and Amendments |
| Unit 3 | Chapter 4 – Lesson 4.3: Trial Designs: Parallel, Crossover and Factorial |
| Unit 4 | Chapter 4 – Lesson 4.4: Adaptive Clinical Trial Designs |
| Unit 5 | Chapter 4 – Lesson 4.5: Blinding and Randomization |
| Module 5 | Chapter 5 — IRB and IEC Review |
| Unit 1 | Chapter 5 – Lesson 5.1: Purpose, Composition and Authority of the IRB/IEC |
| Unit 2 | Chapter 5 – Lesson 5.2: Types of Review: Full, Expedited and Exemption |
| Unit 3 | Chapter 5 – Lesson 5.3: Continuing Review and Reporting Requirements |
| Module 6 | Chapter 6 — Investigator Responsibilities and Regulatory Bodies |
| Unit 1 | Chapter 6 – Lesson 6.1: Investigator’s Role and Responsibilities |
| Unit 2 | Chapter 6 – Lesson 6.2: Communication with the IRB/IEC |
| Unit 3 | Chapter 6 – Lesson 6.3: Global Regulatory Bodies |
| Module 7 | Chapter 7 — Investigator Site Oversight |
| Unit 1 | Chapter 7 – Lesson 7.1: Investigator Site Qualifications and Resources |
| Unit 2 | Chapter 7 – Lesson 7.2: Investigator Oversight and Delegation of Tasks |
| Unit 3 | Chapter 7 – Lesson 7.3: Oversight of the Informed Consent Process |
| Unit 4 | Chapter 7 – Lesson 7.4: Investigational Product Accountability |
| Unit 5 | Chapter 7 – Lesson 7.5: Protocol Compliance and Regulatory Requirements |
| Module 8 | Chapter 8 — Sponsor Responsibilities and Monitoring |
| Unit 1 | Chapter 8 – Lesson 8.1: Sponsor’s Overall Responsibilities |
| Unit 2 | Chapter 8 – Lesson 8.2: Risk-Based Quality Management (RBQM) |
| Unit 3 | Chapter 8 – Lesson 8.3: Role of the Clinical Research Associate (CRA) |
| Unit 4 | Chapter 8 – Lesson 8.4: Centralized Monitoring |
| Unit 5 | Chapter 8 – Lesson 8.5: Monitoring Plan Components and Requirements |
| Module 9 | Chapter 9 — Informed Consent and Participant Rights |
| Unit 1 | Chapter 9 – Lesson 9.1: Key Elements of a Valid Informed Consent Form |
| Unit 2 | Chapter 9 – Lesson 9.2: The Informed Consent Discussion |
| Unit 3 | Chapter 9 – Lesson 9.3: Special Considerations for Vulnerable Populations |
| Unit 4 | Chapter 9 – Lesson 9.4: Electronic Consent and Regulatory Acceptance |
| Unit 5 | Chapter 9 – Lesson 9.5: Participant Rights and Withdrawal from a Study |
| Module 10 | Chapter 10 — Safety Reporting and Pharmacovigilance |
| Unit 1 | Chapter 10 – Lesson 10.1: Definitions: AE, SAE and ADR |
| Unit 2 | Chapter 10 – Lesson 10.2: Seriousness Criteria and Expectedness |
| Unit 3 | Chapter 10 – Lesson 10.3: Immediate Reporting Requirements and Timelines |
| Unit 4 | Chapter 10 – Lesson 10.4: Overview of Pharmacovigilance (PV) |
| Unit 5 | Chapter 10 – Lesson 10.5: Safety Data Reconciliation |
| Module 11 | Chapter 11 — Site Initiation and Inspection Readiness |
| Unit 1 | Chapter 11 – Lesson 11.1: Purpose and Execution of the Site Initiation Visit (SIV) |
| Unit 2 | Chapter 11 – Lesson 11.2: Reviewing the Investigator Site File (ISF) Setup |
| Unit 3 | Chapter 11 – Lesson 11.4: Regulatory Inspection Readiness in Clinical Trials |
| Module 12 | Chapter 12 — Site Closeout and Final Activities |
| Unit 1 | Chapter 12 – Lesson 12.1: Final Site Activities and the SCV Process |
| Unit 2 | Chapter 12 – Lesson 12.2: Archiving Essential Documents and Retention Periods |
| Unit 3 | Chapter 12 – Lesson 12.3: Final Investigational Product Accountability |
| Unit 4 | Chapter 12 – Lesson 12.4: Reporting Final Results and Disclosure to Participants |
| Module 13 | Chapter 13 — Digital Transformation and Decentralized Clinical Trials |
| Unit 1 | Chapter 13 – Lesson 13.1: Introduction to Decentralized Clinical Trials (DCTs) and Hybrid Models |
| Unit 2 | Chapter 13 – Lesson 13.2: Technology in Decentralized Clinical Trials |
| Unit 3 | Chapter 13 – Lesson 13.3: Remote Source Data Verification (rSDV) and Its Challenges |
| Unit 4 | Chapter 13 – Lesson 13.4: Regulatory and Ethical Considerations for Remote Conduct |