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Virtual

Jan 14, 2022 10:00 AM - Jan 14, 2022 1:00 PM

Short Course 3: Getting Real About Inspections

Instructors

Linda J. Scarazzini, MD, RPh

Linda J. Scarazzini, MD, RPh

Vice President, Pharmacovigilance and Patient Safety, AbbVie, United States

She is currently Vice President, Head of Pharmacovigilance and Patient Safety at AbbVie. Prior to joining AbbVie, Dr. Scarazzini served as Director of the Division of Pharmacovigilance in the Office of Pharmacovigilance and Epidemiology, CDER, FDA. She began her career in pharmacovigilance at Sanofi-Aventis, ultimately serving as Associate Vice President of Pharmacovigilance and Risk Management. In 2016, she was selected by her industry peers to serve as the BioPharma Representative on FDA Drug Safety and Risk Management Advisory Committee. Dr Scarazzini’s publications include the recently-released textbook “Pharmacovigilance: A Practical Approach,” as co-author and co-editor along with members of her AbbVie PV team

Carrie  Scott

Carrie Scott

Head, Global PV Compliance and Policy, Pharmacovigilance and Patient Safety, AbbVie Ltd, Portugal

Currently Director of Global Safety Compliance, with responsibility to set strategic direction for an optimised pharmacovigilance quality management system. Carrie holds a BSc Biochemistry with Pharmacology. Carrie worked at the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK, holding a variety of positions, including Pharmacovigilance Inspectorate Operations Manager & Senior Pharmacovigilance Inspector, and other roles in the Enforcement and Post-Licensing Divisions. Carrie took a lead role in the publication of the MHRA's Good Pharmacovigilance Practice Guide and also contributed to the development of the EU Good Vigilance Practice modules. Carrie has also held other PV Compliance and Quality Assurance roles.

Nusrat  Sultani

Nusrat Sultani

Associate Director Safety Compliance, Abbvie, United States, United States

I have been in the pharmaceutical industry for 20 years. About half the time focused in clinical trial management and the recent half focused on compliance, mainly supporting PV related audits and inspections. I find inspections and audits to be truly learning experiences and a chance to showcase how well your system and processes function but to also learn what can be even better.

Rebecca  Webb

Rebecca Webb

Director, Pharmacovigilance Quality Assurance, Abbvie, United Kingdom

Rebecca is the Director of Pharmacovigilance Quality Assurance at AbbVie, having joined in January 2016. Prior to this Rebecca spent 10 years at the UK Medicines and Healthcare products Regulatory Agency (MHRA) in variety of operational roles within the Vigilance and Risk Management of Medicines division and later as a Senior Pharmacovigilance Inspector within the Inspection, Enforcement and Standards division.

Patrick  Spracklin, MBA

Patrick Spracklin, MBA

Senior Director, PV Process, Technology, Data and Innovation, AbbVie, Inc., United States

Pat leads the Process, Technology, Data, and Innovation organization at Abbvie. In this position Pat leads efforts to continuously improve and innovate across Abbvie's PV System. Pat has a BS in Manufacturing Engineering from Bradley University in Peoria, Illinois and an MBA from Lake Forest Graduate School of Management.

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