2nd Annual Risk Management & Pharmacovigilance America Summit

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2nd Annual Risk Management & Pharmacovigilance America Summit
Date October 24 - 26, 2017
Place Boston, USA

The requirement to fully understand the risks and benefits of pharmaceutical products through all phases of their lifecycle has fueled the need for more efficient and effective pharmacovigilance solutions to protect patients and manufacturers against risk and ensure regulatory compliance.

Maintaining pharmacovigilance data is a mandatory, yet time intensive and costly process that ultimately contributes little to your company’s bottom line revenue. As such, the need to minimize these costs, yet remain compliant is crucial to your business success.

EXTEDO’s PcVmanager is a comprehensive, cost effective and easy to deploy solution designed to streamline your pharmacovigilance processes. It enables you to classify, create, review, submit and maintain pharmacovigilance data and adverse event reports within a single, easy-to-use application.2nd Annual Risk Management and Pharmacovigilance America Summit[1] comes as a continuation of the successful last year´s meeting of the best PV experts on the market. This upcoming October, we will discuss a wide range of topics and areas within drug safety and risk management. As we all know, this field is very important for the whole population and it absolutely requires the constant education and sharing expertise of the best PV professionals. If you want to stay updated with the current Pharmacovigilance issues, do not miss this meeting hold on 24 - 26 October in Boston. Companies such as Astellas, GSK, Merck, Janssen, CSL Behring, Sanofi Pasteur, Otsuka and many more will share case studies and their opinions on topics such as Risk Minimization, Social listening, Outsourcing of Pharmacovigilance, Data Management and Data Mining, RMPs update, function of the Safety Management Teams, New technologies in PV and many others.[2]

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  • The requirement to fully understand the risks and benefits of pharmaceutical products through all phases of their lifecycle has fueled the need for more efficient and effective pharmacovigilance solutions to protect patients and manufacturers against risk and ensure regulatory compliance. Maintaining pharmacovigilance data is a mandatory, yet time intensive and costly process that ultimately contributes little to your company’s bottom line revenue. As such, the need to minimize these costs, yet remain compliant is crucial to your business success. EXTEDO’s PcVmanager is a comprehensive, cost effective and easy to deploy solution designed to streamline your pharmacovigilance processes. It enables you to classify, create, review, submit and maintain pharmacovigilance data and adverse event reports within a single, easy-to-use application.Lessons learned from the risk minimization strategies
  • Function of the Safety Management Teams
  • Safety Review of products in development and post-marketing
  • What are the potential uses for social media to improve drug safety?
  • Vendor management and outsourcing of pharmacovigilance services
  • New definitions in the Maternal Immunization (MI) Pharmacovigilance
  • Risk Management Plans rule amendments
  • Evolving themes for Safety Signal Detection in Clinical Development and post-Marketing
  • New technologies in Pharmacovigilance
  • Benefit-Risk Management

Key Speakers

Milbor D'Silva

Vice President, Head of Safety Science & Site Head for VP Pharmacovigilance

Astellas Pharma Global Development

Susan Welsh

Chief Safety Officer

CSL Behring

Harry Seifert

Executive Director, Clinical Safety Sciences

GlaxoSmithKline Vaccines

Annie Tougas

Associate Director, Pharmacovigilance & Medical Information

Otsuka Canada Pharmaceutical Inc.

Ann Straus

AVP CSRM

Merck

References

  1. http://pharmacovigilancesummit.com/
  2. http://www.allanlloyds.com/upcoming-events/107/2nd-annual-risk-management-and-pharmacovigilance-america-summit-2017/

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