New Perspectives in Pharmacovigilance@Mumbai on 23rd July 2011

New Perspectives in Pharmacovigilance@Mumbai on 23rd July 2011


About The Event

Safety  monitoring  during clinical development and post marketing Pharmacovigilance  are critical practices in the development and evaluation of medicinal products.  Constantly evolving  international and  Indian  drug regulations are forcing companies to look more closely at their pharmacovigilance systems and develop core competencies of data collection, monitoring, assessment and analysis. The workshop aims to integrate various perspectives on development of capabilities  and  systems with a focus on processes related to  risk identification and mitigation. Also discussed will be the challenges associated with in/out-licensing of products and those brought about by the emerging trend of outsourcing of Pharmacovigilance services. The workshop will conclude with an opportunity for the target audience  -new and mid career professionals to pose questions and discuss their doubts through an open session and network with like minded professionals.

Workshop Topics  

  1. Pharmacovigilance: The scientific perspective
  2. Pharmacovigilance: The industry & regulatory perspectives
  3. An overview and comparison of Indian & international PhV regulationsï
  4. Systems and processes of post marketing Pharmacovigilance: The key stakeholders
  5. Pharmacovigilance for clinical trials
  6. Writing high quality patient narratives
  7. Emerging areas and what you need to know
  8. Evaluating safety of licensed products
  9. Negotiating Safety Data Exchange Agreements

Trainers’ Profile  

Dr Sushrut Bhatt Dr Sushrut Bhatt is a Medical & Clinical Research Professional with excellent theoretical, functional & operational knowledge & holistic understanding of various aspects of Clinical Research & Medical Operations. He currently leads Pharmacovigilance Operations for developmental and marketed products for a top tier MNC and is also responsible for Quality Standards of the Medical Division. Having held diverse roles and responsibilities within the Medical & Clinical Research domains,  he brings a unique perspective and deep understanding of the science and challenges faced in deploying a successful Pharmacovigilance System.  He  is regularly  invited as  an international speaker on topics related to clinical research & drug safety and other national level forums. Dr Bhatt is a member of the British Association for Research Quality Assurance. He tries to combine his responsibilities with a special interest in Training & Development and has to his credit several training initiatives in the companies he has worked for.

Who should attend? 

This training program is ideal for:

  • Individual who is working in Clinical Research/Pharmaceutical industry/Regularities bodies.
  • Student/research scholar/faculty who aspire to work in the field of pharmacovigilance. 

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