Agenda – The 2nd Pharmacovigilance Audit and Inspections Conference

  • Day One
  • Day Two

Day One

 MONDAY, MARCH 25

8:45AM – 9:00AM

Chairperson's Opening Remarks
Kevin P. Malobisky, Ph.D., M.S., RAC, Senior Vice President Global Regulatory Affairs, Quality and Compliance, ACHILLION PHARMACEUTICALS

9:00AM – 9:45AM

Successful PV Inspections: Does Your CAPA System Hold the Key?
Nusrat Sultani, Associate Director, PV Compliance, Global Patient Safety Evaluation (GPSE) Compliance, TAKEDA PHARMACEUTICALS

9:45AM – 10:30AM

Prepare for GMP Inspection
Julie Miller, Deputy Director, Audit and Inspection Readiness Manager, SANOFI

10:30AM – 11:00AM

Networking Break

11:00AM – 11:45AM

Walk Through Inspection Readiness
Claudia Nolte, Director of PV Quality Assurance (PVQA), CSL BEHRING

11:45AM – 12:30PM

Review of Updates on GCP EMA Guidance: EMA Risk Management Plan
Fawad Piracha, Risk Management, Pharmacovigilance/Risk Management, REGENERON PHARMACEUTICALS, INC.

12:30PM – 1:30PM

Luncheon

1:30PM – 2:15PM

Navigate a Regulatory Risk-Based Approach to Pharmacovigilance (PV) Supplier Management
Marissa Fernandez, Pharmacovigilance Manager, BAXTER HEALTHCARE CORPORATION

2:15PM – 3:00PM

Master Document Content Quality - An Overlooked Aspect of Audits
Romana Hosain, Head of Risk Management, REGENERON PHARMACEUTICALS, INC.

3:00PM – 3:30PM

Networking Break

3:30PM – 4:15PM

Challenges With PV Audits
Suzanne Elliot, Director, Quality Assurance Pharmacovigilance, MERCK

4:15PM – 5:00PM

Successful Partner Change Management During Multiple Ongoing Development Programs - Best Practices and Lessons Learned
Kevin P. Malobisky, Ph.D., M.S., RAC, Senior Vice President Global Regulatory Affairs, Quality and Compliance, ACHILLION PHARMACEUTICALS

5:00PM –

End of Day One


Day Two

 TUESDAY, MARCH 26

8:15AM – 9:00AM

Continental Breakfast

9:00AM – 9:15AM

Chairperson's Recap of Day One
Kevin P. Malobisky, Ph.D., M.S., RAC, Senior Vice President Global Regulatory Affairs, Quality and Compliance, ACHILLION PHARMACEUTICALS

9:15AM – 10:00AM

Oversight and Management of a Global PV Network
Jaylaxmi Nalawade, M.D., Associate Director, Pharmacovigilance and REMS, LUPIN SOMERSET

10:00AM – 10:45AM

What Makes a Healthy Relationship Between the Quality Unit and PV?
Moderator:
Kevin P. Malobisky, Ph.D., M.S., RAC, Senior Vice President Global Regulatory Affairs, Quality and Compliance, ACHILLION PHARMACEUTICALS

Panelist:
Katie Driscoll-Alberta, Global Head of Quality; R&D, Pharmacovigilance and Commercial Product Samples, ALKERMES

10:45AM – 11:15AM

Networking Break

11:15AM – 12:00PM

Best Practices in Pharmacovigilance
Deepa Arora, Vice President - Pharmacovigilance and Global Head - Drug Safety and Risk Management, LUPIN LIMITED

12:00PM – 1:00PM

Luncheon

1:00PM – 1:45PM

Discuss Recent Trends in Inspection Observation
Richard Wolf, Senior Director Regions and PV Operations, Global Clinical Safety and Pharmacovigilance, CSL BEHRING

1:45PM – 2:30PM

Embrace Cognitive Computing in Pharmacovigilance
Sameer Thapar, Assistant Professor, Drug Safety and PV, RUTGERS UNIVERSITY