Faculty – 2nd Product Complaints Forum

Kaudeja Bano, M.D.
Senior Medical Director, ABBOTT UNIVERSITY

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

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

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

Julii Lindquist
VP Quality and Regulatory, WESTERN ENTERPRISES

view speaker profile

Julii has more than 20 years of 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

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

view speaker profile

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

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

Richard Shields
Consumer Complaint Investigator, Consumer Health, BAYER

Vaishali Shukla
Director, Due Diligence and Quality Integration, SHIRE

Sameer Thapar
Assistant Professor and Advisor, Drug Safety and Pharmacovigilance, RUTGERS

view speaker profile

Dr. Sameer Thapar holds a doctorate of pharmacy, is Oracle Health Science Consulting’s Director of Global Pharmacovigilance, and is on faculty as Assistant Professor for the Drug Safety and Pharmacovigilance track of the Master in Clinical Trial Sciences program at Rutgers University. Dr. Thapar has 18 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. He is an active advisor in several U.S.-based life science industry conferences and participates as an invited speaker and panelist at global industry conferences.

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

view speaker profile

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.

Michael Van Ryn
Sr. Staff Regulatory Compliance Specialist, STRYKER