Medical Review
Medical review in pharmacovigilance is the process of assessing individual case safety reports (ICSRs) or aggregated safety data to determine the causality, seriousness, and expectedness of adverse events associated with a drug. This process is instrumental in safeguarding the well-being of patients and guiding decisions about the benefit-risk profile of a pharmaceutical product.
Program Highlights
Modules-
20
HRS of Learning-
100+
Weeks -
6
Sample Medical Review Cases -
150+
Real World Scenarios-
100+
Program Overview
The Medical Review in Pharmacovigilance program is designed to provide participants with the specialized knowledge and skills required for assessing adverse events and ensuring drug safety within the pharmaceutical industry. Through a combination of theoretical instruction and hands-on training, participants will become proficient in the causality assessment, seriousness evaluation, and expectedness determination of adverse events.
- Provide an in-depth understanding of the significance and responsibilities associated with medical review in drug safety surveillance.
- Train participants in determining the likelihood of a causal relationship between a drug and an adverse event. Equip them with skills in identifying potential safety signals.
- Instruct participants on assessing the seriousness of adverse events based on regulatory criteria. Provide guidance on reporting requirements to regulatory authorities.
- Familiarize participants with the concept of expectedness and how it pertains to the known pharmacology and indications of a drug.
- Provide skills in conducting a thorough benefit-risk assessment for pharmaceutical products, considering both therapeutic benefits and potential risks.
- Train participants in analyzing safety data from various sources and interpreting information in aggregate reports, such as PSURs and DSURs.
- Highlight the importance of interdisciplinary collaboration with healthcare experts in the assessment of adverse events.
- Emphasize the ethical considerations and patient-centric approach required in the evaluation of drug safety.
- Ensure participants understand the regulatory standards and quality assurance measures essential for accurate and timely safety reporting.
- Provide hands-on experience through case studies and practical exercises that simulate real-world scenarios in medical review.
Program Objectives
- To Understand study data that is collected, organized, and saved to meet compliance requirements,such as CFR21 Part 11, good manufacturing practices (GMP),and good clinical practice (GCP).
- Develop advanced knowledge of the roles and responsibilities of various functionaries in the CDM department such as Clinical Data Manager, Data Management Assistant, Data Team Lead (DTL),Database Programmer/Designer, Medical Coder/Writer, Clinical.
- Practice the process of Query writing.
- Detailed training in EDC tool and medical writing
- Thorough knowledge of Protocol Review and CRF Review
- Competence in managing end to end process in Data Management Plan.
- Working experience in EDC tool and edit checks writing.
- Soft skills development for Interview success.
Target Audience
- Medical graduates with MBBS, MD, DO, Ph.Ds',
- Dental graduates with BDS, MDS, DMD, DDS
- Pharmacy graduates with B.Pharm, PharmD
- Ph.D
- Nursing graduates with RN, BS, LPN
- Majors in Biological Sciences/Life Sciences/allied health fields.
- Pharmaceutical Quality analysts
- Microbiology, Biochemistry, Organic Chemistry and Biotechnology students
.
- Health Informatics
- Regulatory affairs
- Medical Affairs
- Clinical Research
- Clinical Data Management or Data sciences
- Clinical Trial Management
- Quality Assurance
- Quality Control
- Pharmacovigilance and Drug Safety
Program Curriculum
Designing a comprehensive curriculum for a Medical Review program involves structuring a course that covers key theoretical concepts and provides hands-on training in practical skills. Here's a suggested outline for a Medical Review program:
- Definition and Significance of Medical Review
- Role and Responsibilities of Medical Reviewers
- Ethical Considerations in Drug Safety Evaluation
- Principles of Causality Assessment
- Types of Causality Relationships (e.g., Certain, Probable, Possible)
- Application of Bradford Hill Criteria
- Criteria for Seriousness Assessment
- Regulatory Reporting Requirements (e.g., ICH E2E(R2), FDA, EMA)
- Expedited Reporting and Timelines
- Definition of Expectedness
- Known Pharmacological Effects and Indications
- Literature Review and Data Mining for Expectedness Assessment
- Methods for Signal Detection
- Data Mining and Statistical Signal Detection
- Risk-Benefit Assessment and Signal Evaluation
- Framework for Benefit-Risk Evaluation
- Factors Influencing Benefit-Risk Profile
- Communication of Benefit-Risk Decisions
- Analysis of Safety Data from Various Sources
- Interpretation of Aggregate Reports (e.g., PSUR, DSUR)
- Benefit-Risk Considerations in Aggregate Reports
- Interdisciplinary Collaboration in Medical Review
- Engaging with Clinicians, Pharmacists, and Experts
- Multidisciplinary Approach to Adverse Event Assessment
- Regulatory Standards for Adverse Event Reporting
- Quality Control Measures in Medical Review
- Compliance with Good Pharmacovigilance Practices (GVP)
- Hands-On Assessment of Adverse Event Cases
- Case Study Analysis and Discussion
- Simulated Medical Review Scenarios
- Ethical Considerations in Medical Review
- Patient-Centric Approach to Adverse Event Assessment
- Balancing Patient Safety and Benefit-Risk Profile
- Integration of Technology in Medical Review Processes
- Use of Artificial Intelligence in Signal Detection
- Future Trends in Drug Safety Evaluation
- Quizzes and Knowledge Checks
- Case Study Analysis and Presentation
- Practical Exercises (e.g., Causality Assessment, Signal Detection)
- Final Exam or Capstone Project
- Guest Lectures from Industry Experts
- Mock Medical Review Scenarios
- Regulatory Affairs and Compliance Workshops
Career Paths
Pharmacovigilance, as a critical aspect of drug safety, offers a range of career opportunities. Here are some common career paths in Pharmacovigilance:
- Responsibilities: Collect and evaluate adverse event reports, ensure compliance with regulatory requirements, and manage safety databases.
- Skills Needed: Attention to detail, knowledge of regulatory guidelines, strong organizational skills.
- Responsibilities: Assess and evaluate adverse event reports for causality and seriousness, provide medical expertise in safety assessment.
- Skills Needed: Medical background (e.g., PharmD, MD), clinical knowledge, analytical skills.
- Responsibilities: Oversee pharmacovigilance activities, ensure compliance with regulatory requirements, lead safety teams.
- Skills Needed: Leadership, regulatory knowledge, project management skills.
- Responsibilities: Develop and implement risk minimization strategies, conduct benefit-risk assessments, and oversee risk management plans.
- Skills Needed: Risk assessment, regulatory knowledge, communication skills.
- Responsibilities: Ensure compliance with quality standards, conduct audits and inspections, implement quality management systems.
- Skills Needed: Quality assurance knowledge, auditing skills, attention to detail.
- Responsibilities: Liaise with regulatory authorities, ensure compliance with pharmacovigilance regulations, and support regulatory submissions.
- Skills Needed: Regulatory knowledge, communication skills, attention to detail.
- Responsibilities: Analyze safety data to identify potential signals, perform benefit-risk assessments, and contribute to risk management strategies.
- Skills Needed: Analytical skills, statistical knowledge, pharmacovigilance expertise.
- Responsibilities: Conduct safety assessments in clinical trials, contribute to study protocols, and provide safety-related guidance.
- Skills Needed: Clinical research knowledge, medical background, analytical skills.
- Responsibilities: Provide training on pharmacovigilance principles, regulatory requirements, and case processing procedures.
- Skills Needed: Communication skills, knowledge of pharmacovigilance practices.
- Responsibilities: Offer specialized pharmacovigilance services to pharmaceutical companies, regulatory agencies, or research organizations.
- Skills Needed: Expertise in pharmacovigilance, business acumen, networking skills.
- Responsibilities: Analyze safety data, perform statistical analyses, and generate safety reports.
- Skills Needed: Statistical knowledge, data analysis skills, pharmacovigilance expertise.
- Responsibilities: Manage pharmacovigilance databases and IT systems, ensure data integrity and security.
- Skills Needed: IT skills, database management knowledge, attention to detail.
Remember, these career paths often have room for advancement, specialization, and crossover into related fields like regulatory affairs, clinical research, or quality assurance. Continuous learning and staying updated with industry trends and regulations are crucial for success in Pharmacovigilance.