Agenda – Pharmacovigilance Audit and Inspections Conference

  • Day One
  • Day Two

Day One

 Monday, March 26

8:45AM – 9:00AM

Chairperson’s Welcome and Opening Remarks
Susan Welsh, Chief Safety Officer, CSL BEHRING

9:00AM – 10:15AM

Data Integrity for PV in Preparation for Audits/Inspections
Patrick Hoegen, Associate Director, PV Quality and Compliance, Alkermes, Inc.

10:15AM – 11:00AM

CASE STUDY: Allergan Audit/Inspection Readiness Program
Rena Pandit, Director, Inspection Readiness, Global Patient Safety and Epidemiology (GPSE), ALLERGAN

11:00AM – 11:30AM

Networking Break

11:30AM – 12:15PM

CASE STUDY: Pharmacovigilance Exchange Through Pfizer’s PvX
Boris Videlov, Head PV Licensing, PFIZER

12:15PM – 1:00PM

Ensure Inspection Readiness Through Mock Inspections
Deanna Montes de Oca, Associate Director, PV Operations Clinical Safety and Pharmacovigilance, OTSUKA

1:00PM – 2:00PM


2:00PM – 2:45PM

Technological Advancements and Their Impact on Data Management
Sameer Thapar, Assistant Professor, Drug Safety and PV, RUTGERS UNIVERSITY

2:45PM – 3:30PM

Networking Break

3:30PM – 4:15PM

Pharmacovigilance (PV) Audits Through the Perspective of an Auditor and Auditee
Marissa Fernandez, Pharmacovigilance Manager, BAXTER HEALTH CORPORATION

4:15PM – 5:00PM

Successful Partner Change Management During Multiple Ongoing Development Programs — Best Practices and Lessons Learned
Kevin P. Malobisky, Senior Vice President Regulatory, Quality, and Pharmacovigilance, KARYOPHARM THERAPEUTICS

Day Two

 Tuesday, March 27

9:00AM – 9:15AM

Chairperson’s Recap of Day One
Susan Welsh, Chief Safety Officer, CSL BEHRING

9:15AM – 10:00AM

Session sponsored by UBC

10:00AM – 10:45AM

Support PV Inspections Activities That Come in Through the GMP Door
Richard Wolf, Senior Director Regions and Pv Operations, Global Clinical Safety and Pharmacovigilance, CSL BEHRING

10:45AM – 11:30AM

Networking Break

11:30AM – 12:15PM

Company Culture and the Impact on Pharmacovigilance Audit and Inspections
Suzanne Elliott, Director (Head), U.S. Medical Compliance, Boehringer Ingelheim

12:15PM – 1:00PM

Oversight and Management of a Global PV Network
Paula Engle, Head of Global PV Compliance, Training and PV Network, GE HEALTHCARE

1:00PM – 2:00PM


2:00PM – 2:45PM

Science and Art of Preparing Efficient CAPAs in Pharmacovigilance
Deepa Arora, Vice President — Pharmacovigilance and Global Head — Drug Safety and Risk Management, LUPIN LIMITED