JADE Pilot Certification Program in Medical Affairs

1. Modulo 4: Statistics (Phase I/II Studies)

1.1. Topic 1: Introduction to Study Designs

1.2. Topic 2: Adaptive Designs

1.3. Topic 3: Evidence, Belief, and Decision from a Statistical Perspective

1.4. Topic 4: Surrogate Endpoints

1.5. Topic 5: Dose Escalation Methods in Phase I Clinical Trials in Oncology

2. Modulo 5: Phase III/IIIb Studies (Statistics)

2.1. Topic 1: The Basic Knowledge in Statistics

2.2. Topic 2: The Principles Underlying Statistical Hypothesis Tests

2.3. Topic 3: Basic Sample Size and Power Calculations in Randomized Controlled Trials

2.4. Topic 4: Statistical Analysis Plan for a Clinical Trial

2.5. Topic 5: Analysis Framework on Data Organization in Spreadsheets for Quantitative Analysis

3. Modulo 6: Statistical Elements of Diagnostic Studies

3.1. Topic 1: Diagnostic Tests: Dichotomous Tests

3.2. Topic 2: Diagnostic Tests: Combining Test Results with Prior Information about the Patient

4. Modulo7: Systematic Literature Reviews and Meta-Analysis

4.1. Topic 1: Critical Appraisal of Medical Literature

4.2. Topic 2: What is a Systematic Review?

4.3. Topic 3: Principles of a Systematic Review and Meta-Analysis (Part 1) - Basic Components of a Systematic Review

4.4. Topic 4: Principles of a Systematic Review and Meta-Analysis (Part 2) - Meta-Analysis and Heterogeneity

5. Modulo 8: Clinical Research Execution

5.1. Topic 1: The International Principles, Guidelines and Ethics on Conduct in Clinical Trials

5.2. Topic 2: The Activities and Issues Involved in Country, Site Selections and Feasibility

5.3. Topic 3: Budgeting for Clinical Trials (Financial Management)

5.4. Topic 4: Regulatory and Ethics, the Competent Authorities (CAs), Central IRBs and Local Ethic Committees

5.5. Topic 5: Project Management In Managing Project Timelines, Vendors and Resourcing

5.6. Topic 6: Management Investigational Product, Clinical Supplies and Study Materials

5.7. Topic 7: Data Management in Clinical Research

5.8. Topic 8: Pharmacovigilance Drug Safety and Medical Monitoring

5.9. Topic 9: Quality and Risk Management in Clinical Research

5.10. Topic 10: Registration, Reporting and Publishing Clinical Study Results

6. Modulo 9: Medical Communications

6.1. Topic 1: Overview of Study Protocols

6.2. Topic 2: Clinical Study Reports: How to Effectively Use Them

6.3. Topic 3: Publication Planning, Preparation and Submission

7. Module 1: Role of Medical Affairs

7.1. Topic 1: The Roles and Responsibilities of Medical Affairs

7.2. Topic 2: The Key Medical Affairs Needs and Activities of Drug Development

7.3. Topic 3: The Objectives and Principles of Scientific Engagement and Medical Governance

7.4. Topic 4: The Objectives and Principles of Medical Science Liaison Interactions

7.5. Topic 5: Introduction to Continuing Medical Education

7.6. Topic 6: The Objectives and Principles of Data Generation Activities - Concept to Publication

7.7. Topic 7: The Principles of Compassionate Use of Unregistered Drugs

8. Modulo 2: Drug Discovery, Development & Regulations

8.1. Topic 1: The End-to-End Process of Drug Discovery, Development, Registration

8.2. Topic 2: The Late Clinical Development and Basic Phase III Trial Design

8.3. Topic 3: The Regulatory Framework of Developing a Medicine

8.4. Topic 4: The Discovery Process to Candidate Selection

8.5. Topic 5: The Pre-Clinical Development

8.6. Topic 6: The Early Clinical Development to Proof of Concept (PoC)

8.7. Topic 7: Vaccine Medical Affairs

8.8. Topic 8: Drug Metabolism and Pharmacokinetics (DMPK) Specific Requirements for Asia Pacific

9. Modulo 3: Epidemiology & Observational Studies

9.1. Topic 1: Introduction to Epidemiology

9.2. Topic 2: Matching Descriptive Study Aims to Appropriate Study Designs

9.3. Topic 3: Matching Analytic Study Aims to Appropriate Study Designs

9.4. Topic 4: Common Observational Study Designs Used in Pharmacoepidemiology Research

9.5. Topic 5: Elements of Design on Sampling

9.6. Topic 6: Elements of Design on Follow-up

9.7. Topic 7: Confounders and Confounding

9.8. Topic 8: Confounder Control – Restriction & Randomization

9.9. Topic 9: Confounder Control – Matching & Stratification

9.10. Topic 10: Measurements

9.11. Topic 11: Descriptive Analysis

9.12. Topic 12: Comparative Analysis – Unadjusted

9.13. Topic 13: Comparative Analysis – Adjusted

10. Modulo 10: Drug Safety

10.1. Topic 1: Introducing Pharmacovigilance

10.2. Topic 2: Individual Case Safety Reports (ICSRs)

10.3. Topic 3: Pharmacovigilance Operations in Clinical Studies

10.4. Topic 4: Risk Management Activities

10.5. Topic 5: Safety Communication

10.6. Topic 6: Management of Product Quality Issues with Pharmacovigilance Implications

10.7. Topic 7: Ensuring the Quality and Compliance of Pharmacovigilance Systems

11. Modulo 11: Product Information & Medical Education

11.1. Topic 1: What is Medical Marketing? A Dialog in ‘Existentialism’

11.2. Topic 2: The Industry Code of Conduct in Advertising / Promotion Regulations and the Difference between Promotional and Educational Activities

11.3. Topic 3: The Different Types and Best Practices for Continuing Medical Education

11.4. Topic 4: Critical Review of Promotional and Educational Materials

12. Module 12: Health Economics

12.1. Topic 1: An Overview of the Healthcare Systems in Asia Pacific Countries

12.2. Topic 2: Health Technology Assessment Principles and Methodology

12.3. Topic 3: Application of Economic Evaluation Analysis in Formulary Listing and Pricing Decision-Making

12.4. Topic 4: Alternative Tools in Regulating Pricing, Reimbursement and Access of New Technologies by Payers

13. SUMMIT

14. Topic 1- JADE-01 - Topic 1: The Roles and Responsibilities of Medical Affairs