Pharmacovigilance in APAC: An Update and Focus on India (PvPI)

Life Sciences, Pharmaceutical Regulation, Pharmaceutical, Drug Safety, Emerging Market,
  • Thursday, March 13, 2014

Increases in drug safety concerns in recent years due to some high profile drug withdrawals have led to a reevaluation of the pharmacovigilance process by stakeholders and more importantly, by regulatory authorities. The increase in the number of Adverse Drug Reactions (ADRs) reported concomitantly resulted in an increase in the volume of data handled.

How can the industry take on such challenges? To understand the pharmacovigilance process a high level of expertise is required to rapidly detect drug risks and to defend the product against an inappropriate removal. Proactive pharmacovigilance throughout the product life cycle is the way forward and the future direction for drug safety in the APAC region.

This webinar will focus on APAC and the following topics:

  • Understanding GVP – New GVP Guideline by EMA & its impact
  • Patient Data Collection System – Reviewing the challenges of complying with changing country regulations in Asia/India
  • Overview and major achievements of PvPI ( Pharmacovigilance Program of India)


Michal Borawski, International Pharmacovigilance Officer for the Asia-Pacific Region Affairs, Sanofi Pasteur

Michal received his Doctorate from The Ernest Mario School of Pharmacy at Rutgers University. He completed a post-doctoral fellowship in Benefit Risk Management at Johnson & Johnson before joining the Global Pharmacovigilance Department at sanofi pasteur. Michal has been with sanofi pasteur for 6 years. He has been located in Singapore the last 4 years serving as the International Pharmacovigilance Officer for the Asia Pacific Region.

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Who Should Attend?

CEOs, Directors, VP, Heads and Team Leaders involved with

  • Legislation and Policy Advice
  • Biosimilar Strategists
  • Business Development – EU, USA, and Emerging Markets
  • Manufacturing
  • Drug Development
  • Bioequivalence
  • Drug and Safety Assessment
  • Market Strategy
  • Regulatory Affairs
  • APIs
  • Intellectual Property
  • Pricing Lead
  • Project Lead

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