Post-Marketing Safety Surveillance: This course provides an overview of post-marketing safety surveillance (PMSS) in the context of both American (FDA) and international (ICH-E2C) regulatory requirements. It begins with an historical overview of PMSS, th
- Hyderabad, India
- Program Type:
- Study Abroad
- Degree Level:
- Academic Year, Fall Semester
- Program Description:
- The pharmaceutical industry is challenged with providing oversight of a drug’s safety throughout the product lifecycle. This includes continually reviewing safety profiles and managing and assessing benefit and risk that arise during and after drug development. This certificate provides a foundation in pharmacovigilance principles to both experienced professionals and those seeking entry into this career field from within and outside the pharmaceutical area.
Post-Marketing Safety Surveillance: This course provides an overview of post-marketing safety surveillance (PMSS) in the context of both American (FDA) and international (ICH-E2C) regulatory requirements. It begins with an historical overview of PMSS, then reviews the role of epidemiological methods in identifying signals and quantifying, assessing, and preventing adverse drug reactions (ADR). Medical/legal issues, benefits and limitations of safety surveillance systems, labeling changes, the ability to refute false signals, and social and ethical obligations inherent in the conduct of PMSS are discussed. Good Pharmacovigilance Operations: Pharmacovigilance’s basic platform involves the receipt and processing of safety data from multiple sources. The mechanics and operations of a pharmacovigilance processing center will be reviewed, including discussions around organizational structure and the business environment, safety database design and structure, MedDRA coding, Medicinal Product Dictionary, human resource management, process excellence, continuous quality Improvement and data exchange agreements. Also covered are the production of regulatory documents (such as CIOMS forms and Periodic Safety Update reports) and regulatory inspections and pharmacovigilance QA. Pharmacoepidemiology: Pharmacovigilance is a quantitative discipline. Understanding how to interpret data in an objective and scientific manner is critical to prudent decision-making. While this is not a course in statistics, it is designed to provide even the non-mathematically inclined student with a comfort level in key areas of pharmacovigilance. Basic statistical principles will be reviewed, including epidemiology concepts of ratios and rates, quantitative measures of benefit, and exposure estimation. Signaling and surveillance will be covered, along with the interpretation of clinical, post-marketing, and epidemiologic studies, business metrics, and compliance science.
- Setting Description:
- ELIGIBILITY: 1.A postgraduate or graduate in Bachelors of Science, Masters in Science, MBBS or BDS including Medicine, Pharmacy, Nursing, Life Sciences (with any of the following subjects: Botany, Zoology, Biochemistry, Microbiology, Genetics, Biotech) 2. Graduated with minimum 60 percent 3. TOEFEL score: 585 paper based exam, 230 for computer based or 85 for online exam
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