Faculty – 2nd Product Complaints Forum

Khaudeja Bano
Senior Medical Director, ABBOTT

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Khaudeja is a Physician with a Masters in Clinical Research (UCSD), Pharmaceutical engineering Certification, a Database Administrator and a certified Project Management Professional.

She is an Abbott President’s award winner, avid Toastmaster and certified coach. Khaudeja has more than 25 years’ professional experience, including clinical practice. She has held several global medical positions at Guidant, Abbott, and AbbVie Inc. Her career includes global medical / clinical and safety leadership roles in devices, diagnostics, pharmaceuticals and combination products.

She currently serves as the chair for the Post Marketing Safety working group for the Combination Product Coalition (CPC).

Gregory Ellis
Senior Manager Product Monitoring, Quality Assurance, ALEXION PHARMACEUTICALS

Joe Falvo
Senior Manager: Postmarket Risk Management, ORTHO CLINICAL DIAGNOSTICS

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With over 32 years of industry experience in Research & Development along with Quality, Regulatory and Compliance responsibilities, Joe has managed recalls and development of worldwide recall strategies for Ortho-Clinical Diagnostics for over 19 years. He liaises with numerous FDA District Offices (CDRH and CBER) regarding initial and follow-up recall reports, as well as supports the reporting of field actions to global Competent Authorities such as MHRA, ANSM, MHLW, etc. Joe expanded his responsibilities to Managing the Complaint Handling Unit in 2007, which included reportability determination, Regulatory Reporting (MDRs, Adverse Event Reporting, etc.), authoring of Health Hazard Evaluations, etc. As a recall/field action Subject Matter Expert, Joe has also provided expertise to other companies.

Krishna Kotha
Associate Director- External Manufacturing, DR. REDDY’S LABORATORIES

Julii Lindquist
VP Quality and Regulatory, WESTERN ENTERPRISES

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Julii has more than 15 years of medical device experience in managing Corporate Quality Systems and regulatory compliance, including 12 years in the Army, eight years with a titanium manufacturer and the last 13 years in the medical device field. Julii obtained her M.S. degree at the University of Nebraska and is an ISO 13485 certified Lead Auditor, has a RAC (Regulatory Affairs Certification) from RAPS (Regulatory Affairs Professional Society) and a Six Sigma blackbelt, and is an ASQ Certified Quality Auditor. Julii’s passion has always been developing and improving quality systems with focus on Audit, CAPA, Training and Management Review.

Linda Lum
Team Lead Pharmacovigilance Science, Global Pharmacovigilance and Epidemiology, BRISTOL-MYERS SQUIBB

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Linda Lum, PharmD MBA RPh, is a Director in Global Pharmacovigilance and Epidemiology at Bristol-Myers Squibb (BMS) Company in Princeton, NJ with 20 years of pharmaceutical industry experience. She serves as a team lead in the Pharmacovigilance Science group which performs signal detection, manages medical surveillance teams, answers safety data queries, and authors sections of regulatory reports. As project leader for multiple continuous improvement projects, she enjoys developing and implementing innovative processes to create efficiencies while meeting the changes in regulatory requirements. Her experience includes participation in the initiation of product quality review activities as part of signal detection. Linda serves as a preceptor for the BMS collaboration in the Rutgers Pharmaceutical Industry Fellowship Program. She is the recipient of multiple BMS recognition awards including the 2014 Global Regulatory & Safety Sciences Distinction Award. She received her Doctor of Pharmacy degree from University of the Sciences, Philadelphia College of Pharmacy.

Jaylaxmi Nalawade
Senior Manager – Drug Safety and Risk Management, LUPIN LIMITED

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Dr. Jaylaxmi Nalawade is a Medical Doctor with seven years of pharmaceutical industry experience in centralized management of global pharmacovigilance activities. She is an experienced professional in Medical Writing, Risk Evaluation and Mitigation Strategy (REMS), & Risk Management Planning and Implementation, Safety data exchange agreements. Jaylaxmi is currently working as a Senior Manager in Drug Safety and Risk Management department of Lupin Limited (India). In her current role, 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 in India and overseas subsidiaries in the U.S., Europe, Australia. She has worked in integration teams for effective implementation of pharmacovigilance activities in the U.S., Europe, & Australia. She is also a medical expert for review of aggregate safety reports. 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 her MBBS from Maharashtra University of Health Sciences, followed by a Post Graduate Diploma in Clinical Research and Regulatory Affairs (PGDCRRA) from Haffkine Institute for Training, Research, & Testing.

Sonny T. Nguyen
Director of Quality Assurance and Regulatory Affairs, PERIGEN

Rupesh Patel
Product Quality Complaint Lead, Associate Director, OTSUKA

Sharon Perez, Ph.D.
Director, Global Medical Safety, NOVOCURE

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Sharon Perez, Ph.D. is Director of Global Medical Safety at Novocure. She has spent 20 years in the pharmaceutical and medical device industries, focusing on global patient safety in both the clinical and commercial settings. Her experience also includes risk management, GxP compliance, quality system auditing, and FDA/Notified Body/PDMA inspections. In her current role, Sharon is responsible for all post-marketing vigilance and surveillance activities worldwide, including complaint investigation and regulatory reporting. Sharon obtained a Bachelor of Science in Biotechnology from Rochester Institute of Technology, a Ph.D. in Molecular & Cell Biology from the University of Maryland and was a post-doctoral fellow in Neuroscience at Harvard Medical School.

Lawrence Perruzza
Director/Head, Case Investigation and Resolution, ROCHE

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Larry Perruzza is Director of Case Investigation and Resolution for Roche Molecular Diagnostics. Larry has 15 years of leadership experience in post market surveillance and vigilance, including, complaint management, adverse event reporting, field actions, CAPA and audit management within the in vitro diagnostics industry. During his career, Larry has developed quality system processes, led continuous improvement and integration initiatives, and designed and implemented innovative, customer-centric solutions focused on ensuring patient safety, reducing risk and complying with global requirements, including, US FDA Regulations (21 CFR Parts 7, 11, 600, 803, 806 and 820), in vitro Diagnostics Medical Devices Directive (98/70/EC), ISO 13485 and Canadian Medical Devices Regulations (SOR/98-282). In addition, Larry has extensive experience leading within a global, matric organization, developing high performing teams and organizational strategy. Larry received his BSc in Biology from Monmouth University and his MSc in Quality Assurance and Regulatory Affairs from Temple University.

Richard Shields
Consumer Complaint Investigator, Consumer Health, BAYER

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Richard Shields is a Quality Specialist for Bayer’s Quality Assurance Consumer Health Regulatory Compliance group. His primary focus is on supervision of staff performing consumer complaint investigations for products manufactured and packaged by Bayer’s Consumer Health OTC business located in Myerstown, Pennsylvania. In this role, Rich reviews complaint assessments, confirms the investigation conforms to all required testing and/or evaluations, and assigns final risk ratings and justifications. He also represents the site as the subject matter expert on consumer complaints during regulatory audits.

Rich has over 25 years of experience in both supervisory and non-supervisory roles at Johnson Matthey, Eurofins (Lancaster Laboratories), LANXESS Sybron Chemicals, and Bayer. He has a BS in Chemistry and an MBA from Drexel University.

Vaishali Shukla
Director, Due Diligence and Quality Integration, SHIRE

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Vaishali Shukla is the Director of Due Diligence and Quality Integration at Shire Pharmaceuticals. Vaishali is a Quality Compliance leader with over 14 years’ of experience in the biopharmaceutical industry, with expertise in a broad variety of subjects ranging from early clinical development (IND/NDA/ANDA/BLA) to commercialization of biologics & small molecules (solid oral dosage forms/liquid/inhaled). Vaishali started her career in Quality Assurance at BioVest Internationals, where she implemented novel processes for continuous development. She went on receive recognition for her contributions to the Quality systems at both Takeda and Shire Pharmaceuticals, and in her current role at Shire, she is responsible for Legal Entity Integration, Divestiture, Partnerships, Continuous Improvement and various Quality Systems. Vaishali holds a BS in Biology, a Masters in Botany, a Masters in Regulatory Affairs for Drugs, Biologics and Medical Devices and is currently a PhD candidate for Pharmaceutical Economics and Policy.

Sameer Thapar
Assistant Professor and Advisor, Drug Safety and Pharmacovigilance Rutgers, THE STATE UNIVERSITY OF NEW JERSEY

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Dr. Sameer Thapar holds a doctorate of pharmacy (PharmD) and is Oracle Health Science Consulting’s Global Pharmacovigilance Director, based in the US and has held an academic role of Professor, Drug Safety and Pharmacovigilance at Rutgers 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 US based life science industry conferences and participates as an invited speaker and panelist in global industry conferences.

Sophie Vaillot
Regulatory Affairs Director and Leader of Global Postmarket, GE HEALTHCARE

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Sophie has a pharmacy Ph.D., completed with a regulatory affairs degree from a French University. Her doctoral thesis was focused on medical device regulation.

Sophie started her carrier working for the French competent authority (ANSM) in the medical device vigilance department, where she oversaw complaint handling but also focused on training and communication to health professionals and the public. She later took a more international role and played an active part in improving the cooperation between competent authorities and increasing process harmonization.

Sophie then joined GE Healthcare in 2009, where she is now Regulatory Affairs Director and leads the global postmarket organization for RA. She also provides guidance on how to deal with newly regulated/emerging countries around the world and closely works with the QA organization on process improvements.

Sophie is President of the regulatory affairs group of SNITEM (the French trade association for medical devices manufacturer) and is Chair of the European trade association COCIR postmarket surveillance task force. She also represents the industry in several expert groups of the European Commission and is following closely the new EU medical device regulation.