PHARMACOVIGILANCE & MEDICAL SCIENTIFIC WRITING

Global Institute of Health Science is a pioneer in health science education especially in distance & online education. Global Institute of Health Science is an ISO 21001:2018 Certified health science Institute & globally acclaimed, also certified with copyright approval from IPR Government of INDIA. GIHS have international certification from UASL UK for Quality Control Management System.

WHY CHOOSE US

• BRINGING EXCELLENCE TO HEALTH PROFESSIONALS
• 10+ YEARS OF EXPERIENCE WITH INTERNATIONAL EXPOSURE
• INTERNATIONAL ACLAIMED WITH ISO & GOVT APPROVED
• LIFETIME FREE PERSONALIZED TUTORING FOR SUCCESS

Pharmacovigilance Training Program also known as Drug Safety. This is the pharmacological science relating to the collection, detection, assessment, monitoring, and prevention of adverse effects with pharmaceutical products. As such, pharmacovigilance heavily focuses on adverse drug reactions, or ADRs, which are defined as any response to a drug which is noxious and unintended, including lack of efficacy, which occurs at doses normally used for the prophylaxis, diagnosis or therapy of disease, or for the modification of physiological function monitored by the physicians. Medication errors such as overdose, and misuse and abuse of a drug, are also of interest because they may result in an ADR. This GIHS Pharmacovigilance Program designed to provide total overview and skill globally in the field of clinical research and pharmacovigilance. It would help professionals to upgrade & develop their knowledge about pharmacovigilance, regulatory issues and other major aspects of pharmacovigilance. This program will enhance you on medical & scientific writings, you will be expert in Medical writing which involves the development and production of print or digital documents that deal specifically with medicine or health care. The profession of medical writing calls for knowledge in both writing and science, combining a writer’s creative talent with the rigor and detail of research and the scientific process.

SYLLABUS

PHARMACOVIGILANCE

Introduction of Pharmacovigilance

• Overview of Pharmacovigilance

Standard Terms and Terminology in Pharmacovigilance Medical Evaluation of Adverse Events in Pharmacovigilance Adverse Event Reporting System and Form Diagnosis and Managements of ADRs / Medical Evaluation of AE

• Case Processing

Global Perspective of Pharmacovigilance Single Case Processing / Case Narrative Writing

• Pharmacovigilance Reporting Database, Signal Detection, Managements and Risk Assessments & Evaluation

Quality System in PV / Expedited Reporting Criteria PSUR & PBRER / PV Database and Signal Detection Risk Assessments & Management

• Medical Dictionary for Regulatory Activities medDRA

medDRA

• PV laws and Guideline

Regulatory Guideline @ Laws in PV / SOPS in PV PV Auditing and Inspection / Regulatory Aspects in PV MEDICAL/SCIENTIFIC WRITING

• Disease management
• Continuing education and training
• Medical reference and information-gathering
• Practice management and monitoring
• Correct spelling, grammar, and punctuation errors
• Copyedit to make writing accurate, clear, and smoothly flowing
• Ensure correct and consistent data across texts and graphics
• Ensure that the content and its organization comply with the appropriate guidelines and standards

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