Pharmacovigilance Audit and Inspection Conference

Create a Compliant, Effective, and Robust Pharmacovigilance Strategy to Improve Product Quality and Patient Safety


Philadelphia, PA, United States

Being adequately prepared for pharmacovigilance audit and inspections is crucial to any bio/pharma company committed to maintaining the highest standards of safety and risk management. As regulators increase PV audits and inspections, placing greater scrutiny on PV quality management systems, it's up to the sponsor to assess internal activities, vendor relationships, commercial partnerships, and others that compromise the PV system.

This year, at our 2nd Pharmacovigilance Audit and Inspection Conference will focus on the best practices and strategies for those preparing for their audit and inspection, educating PV professionals on new technologies and innovative methods in pharmacovigilance that are emerging, and how to utilize them to improve organizational performance and reporting.

Top Five Reasons to Attend

  1. Examine complex issues such as managing large-scale data sets, facilitating cross-departmental PV engagement, developing detailed audit plans, generating timely and insightful reports, and tracking ever-evolving global regulationsUnderstand how to strategically solve challenges you are currently facing in your PV audits and inspections
  2. Develop a robust PV system that ensures both quality and safety while reaching a continual state of PV audit readiness
  3. Review the pressing issues related to managing the growing volume and frequency of audits and inspections
  4. Analyze feedback of methodology from industry experts
  5. Understand how to strategically solve current challenges facing your PV audit and inspections

Who Should Attend

  • Pharmacovigilance/Drug Safety (QPPV)
  • Regulatory Affairs
  • Quality and Compliance
  • Medical Information
  • Risk Management
  • Compliance
  • Pharmacovigilance Auditors
  • Management Staff Responsible for Running Inspections
  • Employees (Directly and Indirectly) Involved in Inspections
  • Drug/Product Safety
  • Drug Development
  • Information and Clinical Data Management
  • Clinical Pharmacology
  • Clinical Safety
  • Research and Development
  • Quality Assurance
  • Patient Safety
  • Signal Detection
  • Safety Surveillance
  • Outcome Research
  • Data Analysis
  • Epidemiology
  • Medical Affairs
  • Regulatory Affairs and Compliance
  • Information Technology

Speakers

  • Deepa Arora, Vice President Pharmacovigilance and Global Head, Drug Safety and Risk Management, LUPIN LIMITED
  • Katie Driscoll-Alberta, Global Head of Quality; R&D, Pharmacovigilance and Commercial Product Samples, ALKERMES
  • Suzanne Elliott, Director, Quality Assurance Pharmacovigilance, MERCK
  • Paula Engle, Head of Global PV Compliance and Training, GE HEALTHCARE
  • Marissa Fernandez, Pharmacovigilance Manager, BAXTER HEALTHCARE CORPORATION
  • Romana Hosain, Head of Risk Management, REGENERON PHARMACEUTICALS, INC.
  • Kevin Malobisky, Senior Vice President Regulatory, Quality, and Pharmacovigilance, KARYOPHARM THERAPEUTICS
  • Julie Miller, Deputy Director, Audit and Inspection Readiness Manager, SANOFI
  • Jaylaxmi Nalawade, Associate Director, Pharmacovigilance and REMS, LUPIN SOMERSET
  • Claudia Nolte, Director of PV Quality Assurance (PVQA), CSL BEHRING
  • Fawad Piracha, Risk Management, Pharmacovigilance/Risk Management, REGENERON PHARMACEUTICALS, INC
  • Nusrat Sultani, Associate Director, PV Compliance, Global Patient Safety Evaluation (GPSE) Compliance, TAKEDA PHARMACEUTICALS
  • Sameer Thapar, Assistant Professor, Drug Safety and PV, RUTGERS UNIVERSITY
  • Richard Wolf, Senior Director Regions and PV Operations, Global Clinical Safety and Pharmacovigilance, CSL BEHRING

Venue

The Inn at Penn, A Hilton Hotel
3600 Sansom Street
Philadelphia, PA 19104

Discover a huge variety of Philadelphia attractions and activities within minutes of The Inn at Penn, a Hilton hotel. We're right on the campus of the University of Pennsylvania. From museums and tours to art and cultural and family attractions, there's a whole vibrant city to discover.

To make reservations please call 215-823-6240 and request the negotiated rate for ExL's March Meetings. To make reservations online Click Here

The group rate is available until March 4, 2019. Please book your room early as rooms available at this rate are limited.
Event details
Organizer : ExL Events
Venue : The Inn at Penn, A Hilton Hotel, Philadelphia, PA, United States
Event type : Conference
Reference : ASDE-19172