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 ExL's 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.
Speakers: Susan Welsh, Chief Safety Officer, CSL BEHRING, Nusrat Sultani, Associate Director, PV Compliance, Global Patient Safety Evaluation (GPSE) Compliance, TAKEDA PHARMACEUTICALS, Julie Miller, Deputy Director, Audit and Inspection Readiness Manager, SANOFI, Claudia Nolte, Director of PV Quality Assurance (PVQA), CSL BEHRING, Fawad Piracha, Risk Management, Pharmacovigilance/Risk Management, REGENERON PHARMACEUTICALS, INC., Marissa Fernandez, Pharmacovigilance Manager, BAXTER HEALTHCARE CORPORATION, Romana Hosain, Head of Risk Management, REGENERON PHARMACEUTICALS, INC., Suzanne Elliott, Director, MRL QA Pharmacovigilance, MERCK, Kevin P. Malobisky, Senior Vice President Regulatory, Quality, and Pharmacovigilance, KARYOPHARM THERAPEUTICS, Jaylaxmi Nalawade, M.D., Associate Director, Pharmacovigilance and REMS, LUPIN SOMERSET, Katie Driscoll-Alberta, Global Head of Quality; R And D, Pharmacovigilance and Commercial Product Samples, ALKERMES, Deepa Arora, Vice President - Pharmacovigilance and Global Head - Drug Safety and Risk Management, LUPIN LIMITED, Richard Wolf, Senior Director Regions and PV Operations, Global Clinical Safety and Pharmacovigilance, CSL BEHRING, Sameer Thapar, Drug Safety and Pharmacovigilance, TEMPLE UNIVERSITY SCHOOL OF PHARMACY
Time: 8:00 am to 5:00 pm
Early Bird Pricing - Before February 8, 2019: USD 1895.0,
Standard Pricing - After February 8, 2019: USD 2095.0
2nd Pharmacovigilance Audit and Inspection Confe...
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