Pharmacovigilance Risk Management Plan - Webinar

  • ID: 4539778
  • Webinar
  • 60 Minutes
  • Academy of Clinical Intelligence
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Topic Background:

The main objective of the RMP is to improve pharmacovigilance by identifying potential safety issues of human medicinal products, presenting how to reduce these risks and consequently to increase the knowledge about the human medicinal product concerned. Creating an RMP is a complex, challenging and cross-functional process that focuses on evaluating safety issues identified during product development.  

Learning Objectives: At the conclusion of this tutorial, participants should be able to:

  • Discuss the content of Pharmacovigilance Risk Management Plan
  • Describe how to create and maintain a Risk Management Plan so that it can be available on request from regulatory authorities
  • Overcome challenges on preparation and maintenance of Risk Management Plan
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Course Summary:

  • Principles of risk management in Pharmacovigilance
  • Role of risk management plans in pharmacovigilance
  • Developing an Risk Management Plan
  • Structure and Layouts of Risk Management Plan
  • Creating a Pharmacovigilance Plan
  • RMP maintenance and updates
  • QA Session
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  • Sunil Verma Sunil Verma,
    Director ,
    Academy of Clinical Intelligence


    Sunil has been in the Clinical Research Industry for over 10 years. He held the position of Director of Trainings for a leading Contract Research Organization, HAROM Solutions. His company facilitates the business sector by providing Pharmacovigilance services to Pharmaceutical companies and technical trainings to Medicine, Dental, and Pharmacy, Life Science professionals internationally in the fields of Pharmacovigilance, Clinical Research, and Medical Writing etc. He has been involved in trainings throughout his career particularly in the areas of Pharmacovigilance including ARGUS Safety, Clinical Research and Medical Writing. With over 10 years of experience in the pharmaceutical industry and clinical research organization, Sunil offers his clients the assurance that their drug safety training programs are being conducted by a seasoned pharmacovigilance executive with experience in developing, implementing and leading safety trainings in lower cost markets.

    Sunil was formerly Manager, Trainings & Operations of Clinical Research and Pharmacovigilance, where he successfully developed and led more than 8 therapeutic area teams and support training and operations functions for the management of Clinical Data and Adverse Event reporting for human health, including all phases of a product life cycle (drugs, vaccines and devices). Sunil is a client certified trainer with expertise in techno-functional training on Oracle Argus Safety 7.0 including Argus activities, User management, Case processing including duplicate check, case book-in, follow up, coding, medical review, reports generating (Expedited, Aggregated, PSUR) and dashboard reports. He ahs proficiency in WHO-DD and MedDRA Dictionary and knowledgeable in various regulatory guidelines like ICH guidelines, Good Clinical Practices, Good Documentation Practices and Volume 9A etc.

     

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All Professionals are involved in:

  • Pharmacovigilance (including QPPV)
  • Clinical Research
  • Risk Management
  • Drug Safety Assessment Department
  • Safety Data Analysis
  • Pharmacoepidemiology
  • Information Technology
  • Regulatory Affairs
  • Pharmacovigilance consultancy
  • Quality and Compliance
  • Legal
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