Faculty – The 2nd Pharmacovigilance Audit and Inspections Conference

Deepa Arora
Vice President Pharmacovigilance and Global Head, Drug Safety and Risk Management, LUPIN LIMITED

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Dr. Deepa Arora is Vice President Pharmacovigilance and Global Head Drug Safety and Risk Management with Lupin Limited. She is a Physician, having more than 18 years of experience in drug safety and clinical development in the pharma industry and academia.

She has successfully set up world-class Pharmacovigilance systems for Lupin & Lupin subsidiaries in US, Europe, Japan and Australia. Under her able leadership, Lupin has successfully cleared Pharmacovigilance inspections conducted by regulatory authorities across the world.

She is playing an active role in developing awareness and skills of pharmacovigilance in the region by designing teaching modules in Pharmacovigilance & conducting training for medical institutions. She believes in finding innovative solutions to facilitate the translation of PV regulations in enhanced patient safety. She has authored the book on Pharmacovigilance; “Pharmacovigilance- An Industry Perspective” to help youngsters learn relevant aspects of Pharmacovigilance.

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

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Katie transitioned from a career in critical care nursing into the pharmaceutical/biotech industry in the 1990s. Katie spent her career developing global; Quality Assurance Programs, Inspection Readiness Models, Internal System Assessments and Teams to support global GxPs – in the pre/clinical, PV and commercial distribution space. Katie has worked in the wide spectrum of start ups to global commercial pharma corporations from Synergen/Amgen, Cephalon/Teva and now Alkermes. Katie also experienced her own start-up consulting firm Coastal Compliance, LLC, whereby she assisted pharma companies in corporate compliance investigations and due diligence activities.

Suzanne Elliott
Director, Quality Assurance Pharmacovigilance, MERCK

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Suzanne Elliott has served in various positions throughout the drug development lifecycle within the Pharmaceutical Industry for over 25 years. Sue is dedicated to bringing safe and effective life-changing therapies to patients. She started in the industry in the Pharmacovigilance space and worked in various positions of increasing responsibility, which includes Operations, Surveillance, Risk Management, Compliance, Quality, Inspection Readiness, and Quality Assurance. In addition, other areas Sue worked in are Clinical, GCP Compliance, Regulatory Affairs, and as an Auditor conducting various GxP and REMS audits. Sue is a leader in strengthening and executing on the Quality Management System and realizes that a robust QMS is needed to achieve the best outcomes in audits and inspection. She has led Risk Management efforts across the GxP landscape. She currently holds the position of Director, US Medical Compliance, where she is responsible to oversee GxP compliance, provide guidance on GxP non-conformances, and lead Inspection activities. Sue has hosted and supported many PV audits and Inspections. Previous to entering the Industry, Sue worked as a registered nurse in the pediatric unit, and prior to that worked for the Federal Government conducting audits for the Department of Defense under the direction of the Military. Sue holds various certifications in Quality Assurance acquired while working for the Government, a Diploma in Nursing (RN), Bachelors of Science in Health Sciences, Masters of Science in Regulatory Affairs and Quality Assurance, and recently completed an immersion Executive Leadership Program through the Wharton School of Business.

Paula Engle
Head of Global PV Compliance and Training, GE HEALTHCARE

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Paula Engle has been in the pharmaceutical industry for 15 years focusing on Pharmacovigilance. In 2013, she joined GE Healthcare as Manager of PV Compliance. In 2015 she was named Head of Global PV Compliance, Training and PV Network focusing on PV quality activities such as inspection readiness, SOP & training management and oversight of worldwide PV affiliates.

Prior to joining GE Healthcare, she worked for 10 years at Merck in various Drug Safety/Pharmacovigilance roles. She attended the University of Pittsburgh School of Nursing and before joining industry worked in the inpatient hospital setting and managed a family medicine clinical practice.

Marissa Fernandez

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Dr. Marissa Fernandez is the current country head of Baxter’s Patient Safety department in Canada. Marissa is both a pharmacist and a medical doctor by training with more than 25 years of comprehensive knowledge and cross-functional experience in pharmacovigilance, regulatory affairs and quality assurance within the pharmaceutical industry. Marissa has held various roles with increasing responsibilities, is recognized for operational excellence, and has successfully led various national inspections and audits. Marissa has thorough knowledge of pharmacovigilance principles and regulations, including Health Canada, ICH guidelines and the European Medicine Agency’s Good Pharmacovigilance Practices modules. Marissa is concurrently a part-time faculty in the Regulatory Affairs Program of Humber College’s School of Health Sciences in Canada, where she is responsible for courses in medical products safety, regulatory legislations and submissions. She has also recently completed her Certified Quality Auditor Certification from the American Society of Quality.

Romana Hosain

Kevin P. Malobisky, Ph.D., M.S., RAC
Senior Vice President Regulatory, Quality, and Pharmacovigilance, KARYOPHARM THERAPEUTICS

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Dr. Kevin P. Malobisky is a seasoned executive in the pharmaceutical and biotechnology arenas with professional experience in clinical and regulatory drug development, quality assurance, and pharmacovigilance. As a professional with over 26 years of experience, Dr. Malobisky has provided global leadership, management, and strategy across numerous therapeutic domains while working for companies and organizations in the public and private sectors. Kevin earned his bachelor of science degree in microbiology from the Pennsylvania State University, his masters of science in quality assurance and regulatory affairs from the Temple University School of Pharmacy, and his doctorate in organization management from the Capella University School of Business and Technology. Dr. Malobisky is currently the senior vice president of regulatory, quality, and pharmacovigilance at Karyopharm Therapeutics, a clinical-stage biotechnology company developing first-in-class selective inhibitors of nuclear export proteins for the treatment of hematologic and solid organ cancers. He is a member of the senior executive and leadership teams.

Julie Miller
Deputy Director, Audit and Inspection Readiness Manager, SANOFI

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Julie A. Miller is a registered nurse and biologist who has worked for Sanofi Pasteur for over 18 years. The majority of her career with Sanofi has been in Pharmacovigilance in various roles including case management, compliance, quality assurance, and audits and inspections. In her current role, Julie works in PV Quality – Medical, Clinical, and Countries Quality (MCCQ) managing various audits and inspections for PV globally, with a specialization in FDA GMP inspections and medical devices audits and inspections. She is also a PhD candidate in public health and epidemiology at Walden University.

Jaylaxmi Nalawade
Associate Director, Pharmacovigilance and REMS, LUPIN SOMERSET

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Jaylaxmi Nalawade has been in the pharmaceutical industry for around nine years focusing on drug safety and drug development lifecycle. She is currently working an Associate Director of Pharmacovigilance and REMS at Lupin Somerset, USA. She is a physician experienced in centralized management of global pharmacovigilance activities, medical affairs, and medical research in new drug development. She is an experienced professional in Medical Writing, Risk Evaluation and Mitigation Strategy (REMS), Risk Management Planning and
Implementation, PV agreements and PV compliance training. She has led several pharmacovigilance initiatives within cross-functional processes and teams including regulatory affairs, marketing, business development, quality assurance and new product launch teams globally. She has worked in global PV integration across U.S., Europe, and Australia. She has hosted and supported a few PV audits and inspections.

Prior to Lupin, she was an Assistant Manager in Medical Affairs in Unichem Laboratories (India) and as a Medical Reviewer in Pharmacovigilance group with Tata Consultancy Services (India).

She has completed MBBS (the equivalent of MD in the U.S.) from Maharashtra University of Health Sciences, India followed by a Post Graduate Diploma in Clinical Research Management and Regulatory Affairs (PGDCRMRA) from Haffkine Institute for Training, Research, & Testing in India.

Claudia Nolte
Director of PV Quality Assurance (PVQA), CSL BEHRING

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Claudia Nolte is Director, Global Pharmacovigilance Quality Assurance (PVQA) within Global Quality of CSL Behring, being located in Marburg, Germany. In the current role she is responsible for setting up, maintaining and executing CSLBs’ global PV Audit program, as well as for other aspects of the PV Quality Management System including Deviation and CAPA Management, Inspection Preparation and Management, 3rd Party Quality Management, Change Management, and Continuous Improvement.

Claudia holds a Master of Science in Pharmaceutical Medicine from the University of Surrey, Guildford, UK and has been in the pharmaceutical industry for more than 25 years; more than 10 years thereof in various positions within Quality Assurance. Since the implementation of GVP in Europe she has experienced and managed Pharmacovigilance Inspections from several Health Authorities, including MHRA, Swissmedic, PEI, ANSM, and also FDA and Health Canada.

Fawad Piracha
Risk Management, Pharmacovigilance/Risk Management, REGENERON PHARMACEUTICALS, INC

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Fawad assumes responsibilities in Risk Management for early and late stage clinical development programs in infectious diseases and immuno-oncology and completed a post-doctoral fellowship in Pharmacovigilance and Risk Management at Regeneron Pharmaceuticals, Inc., in Tarrytown, NY. Fawad also practices as a community pharmacist on weekends and holidays. He received his Doctor of Pharmacy degree from St. John’s University College of Pharmacy and Health Sciences.

Penelope Przekop
Former Director of Global PV Quality Management, JOHNSON & JOHNSON

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Ms. Przekop is the former Director of Global PV Quality Management, Johnson & Johnson. She has also held leadership positions at Wyeth, Novartis, and Covance. She’s a Quality Systems Engineer and GXP Quality Assurance/ Systems & Compliance Consultant with more than 25 years of industry experience. Her consulting focus is on developing and executing GCP and PV risk-based strategies that support comprehensive global regulatory compliance throughout the drug development process and product lifecycle. She has consulted with numerous top 100 pharma and biotech companies and is often sought out for her broad and deep PV and quality systems experience both from an operational and quality assurance perspective. Ms. Przekop earned a BS degree in Biology from Louisiana State University and an MS degree in Quality Systems Engineering from Kennesaw State University. She’s the author of Six Sigma for Business Excellence (McGraw-Hill) and frequently writes, speaks, and delivers training on quality and compliance topics.

Nusrat Sultani
Associate Director, PV Compliance, Global Patient Safety Evaluation (GPSE) Compliance, TAKEDA PHARMACEUTICALS

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I have been in the industry for the past 18 years and have been involved in compliance aspects for the majority of my time. Initially GCP and most recently PV. Supporting and managing multiple global health authority inspections for the majority of those years. From pre-inspection prep all the way through response development and CAPA implementation. I have also been through and played key roles in multiple major company mergers, acquisitions and transformations throughout my career at Takeda. I have a degree in Psychology from Northwestern University.

Sameer Thapar
Professor, Drug Safety and PV, TEMPLE UNIVERSITY

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Dr. Sameer Thapar holds a doctorate of pharmacy (Pharm.D.) and is Oracle Health Science Consulting’s Global Pharmacovigilance Director, based in the US and concurrently, holds an academic role of Professor, Drug Safety and Pharmacovigilance with a major US University. Dr. Thapar has over 20 years of experience in operations within the pharmaceutical, biotech, and CRO industries, with cross-functional experience in medical affairs, clinical operations, quality assurance, and subject matter expertise in pharmacovigilance operations and compliance. He has built global departments and defended in successful FDA, MHRA, and EMA health authority inspections. Dr. Thapar is an active advisor in U.S.-based life science industry conferences and participates as an invited speaker and panelist at global industry conferences.

Richard Wolf
Executive Director, Head of Pv Operations, GCSP, CSL BEHRING

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Rich Wolf is Senior Director, Regions & Pv Operations in the Global Clinical Safety and Pharmacovigilance group at CSL Behring. He directs Case Management, Medical Evaluation, Pv Systems, and the Regional organization responsible for Pv in affiliates around the world.

CSL Behring is a global leader in the plasma protein biotherapeutics industry. They research, develop, manufacture and market biotherapies that are used to treat serious and rare conditions. Users of their therapies rely on them for their quality of life and, in many cases, for life itself. Corporate Headquarters are in King of Prussia, Pennsylvania in the United States and its parent company CSL is headquartered in Melbourne Australia.

Rich joined CSLB in 2014 after 12 years with Johnson & Johnson serving a number of different roles across Drug Safety, Benefit Risk Management, and Global Medical Safety. He has a BA from the University of Richmond, and MBA from Rutgers University is PMP certified in project management.