EVENT BIO

See breakdown of all you need to know about our Summit

HOT CONFERENCE TOPICS

  • Pharmacovigilance Trends – Global Harmonization
  • PV Regulatory Aspects
  • Social Media and Networks
  • Outsourcing – The Benefits and Challenges
  • Signal Detection and Signal Management
  • Strategic Clinical Drug Safety
  • Good Pharmacovigilance Practices
  • PV Database Management
  • Pharmacovigilance Significance and Scope
  • Clinical Data Management

WHO WILL YOU MEET

Members of board, C-level, Senior Vice Presidents, Vice Presidents, Directors, Heads of departments from Pharma industry / industries involved in:

  • Pharmacovigilance
  • Drug/Product Safety
  • Drug Development
  • Information and Clinical Data Management
  • Clinical Pharmacology
  • Clinical Safety
  • Risk Management
  • Research & Development
  • Quality Assurance
  • Patient Safety
  • Signal Detection
  • Safety Surveillance
  • Outcome Research
  • Data Analysis
  • Epidemiology
  • Medical Affairs
  • Regulatory Affairs and Compliance
  • Information technology
  • Sales and Marketing

PRE-CONFERENCE WORKSHOPS

Workshop A 15:00 - 16:00

The future trends

12 September 2017, 15:00 – 16:00

  • New technologies and innovative methods in pharmacovigilance are emerging, but do you know how to utilize them?
  • Dive deeper into safety and risk management issues and solutions in the EU through real-world experiences
  • Enlightened evolution of regulatory science that speeds needed products to prescribers and patients
  • Future strategies for growth in Pharma
  • Engagement of patients in the future product development and regulatory processes
  • Utilize new approaches to present benefit-risk data and communication of risk-benefit messages to health care providers, patients and consumers

Workshop B 16:00 - 17:00

PV Inspection readiness

12 September 2017, 16:00 – 17:00

  • Would your organization be ready for an inspection of your pharmacovigilance system?
  • What are the current FDA expectations?
  • Discuss common missteps during the course or preparation
  • FDA Pharmacovigilance inspection and its processes
  • Explain the purpose behind pharmacovigilance inspections and their benefit
  • Common inspection observations
  • Plan and conduct a response to inspection observations

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