Pharmacovigilance: ADR Management and Reporting & Outsourcing Trends, A New Drug Safety Webinar from Xtalks

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Xtalks presents an exciting live webinar on Wednesday, December 4, 2013 at 9:00am EST on the benefits and challenges of pharmacovigilance outsourcing and adverse drug reaction management and reporting.

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Join Dr. Marcin Marciniak, Director Drug Safety & Pharmacovigilance, PregLem SA, and member of Gedeon Richter Group and Dr. Philip Jones, BMBS, MA, MSc, PhD, Associate Director & Deputy QPPV, Symogen Limited for an in depth webinar on Adverse Drug Reaction Management and Reporting and Pharmacovigilance Outsourcing Trends.

During this webinar, the following points will be discussed:

Adverse Drug Reaction Management and Reporting

  • Key Requirements
  • Timeliness for expedited reporting
  • Reporting to EudraVigilance
  • Tools and internal industry solutions for being compliant with regulations

Pharmacovigilance Outsourcing Trends

  • Benefits and challenges involved in outsourcing pharmacovigilance processes
  • Advantages and disadvantages of outsourcing
  • Choosing a pharmacovigilance provider
  • Working with your PV provider

*Ensuring oversight of out-sourced activities

  • Brief insights into the role of pharmacovigilance throughout the product lifecycle from clinical development to patient care
  • Presenting a PSUR to external regulatory authorities
  • Main pitfalls
  • Completing the risk-benefit analysis

A live Q&A with the audience will follow the main presentation.

For more information about this online seminar or to register, go to

Xtalks, powered by Honeycomb Worldwide Inc., is a leading provider of educational webinars to the global Life Sciences community. Every year thousands of industry practitioners (from pharmaceutical & biotech companies, private & academic research institutions, healthcare centers, etc.) turn to Xtalks for access to quality content. Xtalks helps Life Science professionals stay current with industry developments, trends and regulations. Xtalks webinars also provide perspectives on key issues from top industry thought leaders and service providers.

To learn more about Xtalks visit

Zayeeta Dasgupta, M.Sc in Life Science and Business Management
+1 (416) 977-6555 ext. 260

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